Trial Outcomes & Findings for Psychological Support for Patients With an Implantable Cardioverter Defibrillator (NCT NCT00152763)
NCT ID: NCT00152763
Last Updated: 2011-01-28
Results Overview
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores \>= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
193 participants
Primary outcome timeframe
Baseline
Results posted on
2011-01-28
Participant Flow
Recruitment commenced in October 2003 at Toronto General Hospital and St. Michael's Hospital in Toronto, Ontario, Canada and concluded in August 2006.
Upon recruitment, participants completed baseline psychological assessment prior to being randomized to the experimental intervention arm (cognitive behaviour therapy) or usual care.
Participant milestones
| Measure |
Usual Cardiac Care - Men
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
19
|
20
|
77
|
|
Overall Study
COMPLETED
|
67
|
14
|
16
|
63
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
4
|
14
|
Reasons for withdrawal
| Measure |
Usual Cardiac Care - Men
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Overall Study
Death
|
4
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
2
|
13
|
Baseline Characteristics
Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Baseline characteristics by cohort
| Measure |
Usual Cardiac Care - Men
n=77 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=19 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=20 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=77 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
61.29 years
STANDARD_DEVIATION 13.17 • n=99 Participants
|
54.58 years
STANDARD_DEVIATION 15.75 • n=107 Participants
|
55.35 years
STANDARD_DEVIATION 18.30 • n=206 Participants
|
64.2 years
STANDARD_DEVIATION 13.35 • n=7 Participants
|
61.68 years
STANDARD_DEVIATION 14.18 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
77 Participants
n=7 Participants
|
154 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intention to treat analyses but data on participants who died over follow-up were omitted.
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores \>= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Hospital Anxiety and Depression Scale - Depression Scale at Baseline
|
4.70 units on a scale
Standard Deviation 3.41
|
7.47 units on a scale
Standard Deviation 5.02
|
5.35 units on a scale
Standard Deviation 3.82
|
4.12 units on a scale
Standard Deviation 4.01
|
PRIMARY outcome
Timeframe: Six-months follow-upPopulation: Intention to treat analyses but data on participants who died over follow-up were omitted.
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores \>= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up
|
4.21 units on a scale
Standard Deviation 3.31
|
4.86 units on a scale
Standard Deviation 3.25
|
5.50 units on a scale
Standard Deviation 4.22
|
3.82 units on a scale
Standard Deviation 3.39
|
PRIMARY outcome
Timeframe: Twelve-months follow-upPopulation: Intention to treat analyses but data on participants who died over follow-up were omitted.
Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores \>= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up
|
4.52 units on a scale
Standard Deviation 3.29
|
4.67 units on a scale
Standard Deviation 4.19
|
5.87 units on a scale
Standard Deviation 3.12
|
4.15 units on a scale
Standard Deviation 3.36
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intention to treat analyses but data on participants who died over follow-up were omitted.
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores \>= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline
|
6.53 units on a scale
Standard Deviation 4.26
|
9.32 units on a scale
Standard Deviation 5.50
|
7.70 units on a scale
Standard Deviation 3.85
|
4.80 units on a scale
Standard Deviation 3.93
|
PRIMARY outcome
Timeframe: Six-months follow-upPopulation: Intention to treat analyses but data on participants who died over follow-up were omitted.
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores \>= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up
|
6.06 units on a scale
Standard Deviation 3.84
|
7.28 units on a scale
Standard Deviation 4.01
|
6.83 units on a scale
Standard Deviation 4.67
|
4.69 units on a scale
Standard Deviation 3.92
|
PRIMARY outcome
Timeframe: Twelve-months follow-upPopulation: Intention to treat analyses but data on participants who died over follow-up were omitted.
Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores \>= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up
|
6.06 units on a scale
Standard Deviation 3.97
|
8.00 units on a scale
Standard Deviation 3.70
|
7.25 units on a scale
Standard Deviation 3.57
|
4.43 units on a scale
Standard Deviation 3.77
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intention to treat analysis although data for participants who died over follow-up were omitted.
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Total Score at Baseline
|
0.81 units on a scale
Standard Deviation 0.66
|
1.56 units on a scale
Standard Deviation 0.99
|
1.20 units on a scale
Standard Deviation 0.85
|
0.63 units on a scale
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Six-months follow-upPopulation: Intention to treat analysis although data for participants who died over follow-up were omitted.
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Total Score at 6-months Follow-up
|
0.70 units on a scale
Standard Deviation 0.52
|
0.76 units on a scale
Standard Deviation 0.83
|
0.68 units on a scale
Standard Deviation 0.64
|
0.54 units on a scale
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: Twelve-months follow-upPopulation: Intention to treat analysis although data for participants who died over follow-up were omitted.
Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Total Score at 12-months Follow-up
|
0.70 units on a scale
Standard Deviation 0.64
|
0.69 units on a scale
Standard Deviation 0.53
|
0.82 units on a scale
Standard Deviation 0.69
|
0.46 units on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: BaselinePsychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Intrusiveness Scale at Baseline
|
0.80 units on a scale
Standard Deviation 0.71
|
1.53 units on a scale
Standard Deviation 0.98
|
1.25 units on a scale
Standard Deviation 0.95
|
0.61 units on a scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: Six-months follow-upPsychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up
|
0.61 units on a scale
Standard Deviation 0.52
|
0.82 units on a scale
Standard Deviation 0.96
|
0.73 units on a scale
Standard Deviation 0.73
|
0.56 units on a scale
Standard Deviation 0.73
|
PRIMARY outcome
Timeframe: Twelve-months follow-upPsychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up
|
0.62 units on a scale
Standard Deviation 0.62
|
0.64 units on a scale
Standard Deviation 0.60
|
0.80 units on a scale
Standard Deviation 0.70
|
0.42 units on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intention to treat analysis although data from participants who died were omitted from analysis
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Avoidance Scale at Baseline
|
0.84 units on a scale
Standard Deviation 0.62
|
1.68 units on a scale
Standard Deviation 1.10
|
1.25 units on a scale
Standard Deviation 0.82
|
0.64 units on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Six-months follow-upPopulation: Intention to treat analysis although data from participants who died were omitted from analysis
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up
|
0.86 units on a scale
Standard Deviation 0.64
|
0.77 units on a scale
Standard Deviation 0.87
|
0.74 units on a scale
Standard Deviation 0.71
|
0.55 units on a scale
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: Twelve-months follow-upPopulation: Intention to treat analysis although data from participants who died were omitted from analysis
Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up
|
0.82 units on a scale
Standard Deviation 0.74
|
0.84 units on a scale
Standard Deviation 0.65
|
0.98 units on a scale
Standard Deviation 0.86
|
0.57 units on a scale
Standard Deviation 0.66
|
PRIMARY outcome
Timeframe: BaselinePsychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Event Scale-Revised Hyperarousal Scale at Baseline
|
0.78 units on a scale
Standard Deviation 0.86
|
1.40 units on a scale
Standard Deviation 1.11
|
1.07 units on a scale
Standard Deviation 0.98
|
0.64 units on a scale
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: Six-months follow-upPsychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up
|
0.61 units on a scale
Standard Deviation 0.70
|
0.64 units on a scale
Standard Deviation 0.87
|
0.56 units on a scale
Standard Deviation 0.61
|
0.52 units on a scale
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: Twelve-months follow-upPsychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up
|
0.64 units on a scale
Standard Deviation 0.73
|
0.57 units on a scale
Standard Deviation 0.54
|
0.67 units on a scale
Standard Deviation 0.70
|
0.39 units on a scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: BaselinePsychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline
|
0.98 units on a scale
Standard Deviation 0.39
|
1.17 units on a scale
Standard Deviation 0.28
|
1.23 units on a scale
Standard Deviation 0.41
|
0.83 units on a scale
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Six-months follow-upPsychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up
|
0.92 units on a scale
Standard Deviation 0.40
|
1.04 units on a scale
Standard Deviation 0.38
|
1.07 units on a scale
Standard Deviation 0.36
|
0.84 units on a scale
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: Twelve-months follow-upPsychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=12 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up
|
0.98 units on a scale
Standard Deviation 0.40
|
1.13 units on a scale
Standard Deviation 0.35
|
1.07 units on a scale
Standard Deviation 0.40
|
0.93 units on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: BaselineQuality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
SF-36 Mental Component Summary Scale at Baseline
|
45.90 units on a scale
Standard Deviation 13.40
|
37.44 units on a scale
Standard Deviation 13.69
|
42.33 units on a scale
Standard Deviation 12.43
|
49.84 units on a scale
Standard Deviation 10.56
|
SECONDARY outcome
Timeframe: Six-months follow-upQuality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
SF-36 Mental Component Summary Scale at 6-months Follow-up
|
48.73 units on a scale
Standard Deviation 10.34
|
43.82 units on a scale
Standard Deviation 11.64
|
45.67 units on a scale
Standard Deviation 10.84
|
51.32 units on a scale
Standard Deviation 10.99
|
SECONDARY outcome
Timeframe: Twelve-months follow-upQuality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
SF-36 Mental Component Summary Scale at 12-months Follow-up
|
49.92 units on a scale
Standard Deviation 10.50
|
46.26 units on a scale
Standard Deviation 14.00
|
41.58 units on a scale
Standard Deviation 9.02
|
51.61 units on a scale
Standard Deviation 46.26
|
SECONDARY outcome
Timeframe: BaselineQuality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
SF-36 Physical Component Summary Score at Baseline
|
39.19 units on a scale
Standard Deviation 10.46
|
36.13 units on a scale
Standard Deviation 7.06
|
37.60 units on a scale
Standard Deviation 11.81
|
38.85 units on a scale
Standard Deviation 10.15
|
SECONDARY outcome
Timeframe: Six-months follow-upQuality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
SF-36 Physical Component Summary Score at 6-months Follow-up
|
42.54 units on a scale
Standard Deviation 10.58
|
41.46 units on a scale
Standard Deviation 12.43
|
41.22 units on a scale
Standard Deviation 12.85
|
42.69 units on a scale
Standard Deviation 10.06
|
SECONDARY outcome
Timeframe: Twelve-months follow-upQuality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=73 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=18 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=16 Participants
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=76 Participants
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
SF-36 Physical Component Summary Score at 12-months Follow-up
|
42.65 units on a scale
Standard Deviation 10.33
|
42.70 units on a scale
Standard Deviation 10.44
|
42.82 units on a scale
Standard Deviation 14.53
|
41.54 units on a scale
Standard Deviation 11.23
|
SECONDARY outcome
Timeframe: 12-months follow-upPercentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.
Outcome measures
| Measure |
Usual Cardiac Care - Men
n=97 Participants
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=96 Participants
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
Percentage of Participants Who Received ICD Therapies
|
30.5 Percentage of participants
|
31.9 Percentage of participants
|
—
|
—
|
Adverse Events
Usual Cardiac Care - Men
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behaviour Therapy - Women
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Cardiac Care - Women
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Therapy Group - Men
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Cardiac Care - Men
n=77 participants at risk
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Behaviour Therapy - Women
n=19 participants at risk
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
|
Usual Cardiac Care - Women
n=20 participants at risk
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
|
Cognitive Therapy Group - Men
n=77 participants at risk
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
|
|---|---|---|---|---|
|
General disorders
Deaths
|
5.2%
4/77
Death was the only adverse event collected.
|
5.3%
1/19
Death was the only adverse event collected.
|
10.0%
2/20
Death was the only adverse event collected.
|
1.3%
1/77
Death was the only adverse event collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jane Irvine
University Health Network, Toronto General Hospital
Phone: (416) 736-5115
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place