Trial Outcomes & Findings for Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention (NCT NCT01542957)
NCT ID: NCT01542957
Last Updated: 2017-03-22
Results Overview
To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.
COMPLETED
NA
128 participants
End of therapy (16 weeks), 3 and 12-month follow-up
2017-03-22
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral + Dilemma Therapy
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.
|
Cognitive Behavioral Therapy
Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
|
|---|---|---|
|
End of Therapy
STARTED
|
65
|
63
|
|
End of Therapy
COMPLETED
|
53
|
53
|
|
End of Therapy
NOT COMPLETED
|
12
|
10
|
|
3-month Follow-up
STARTED
|
53
|
53
|
|
3-month Follow-up
COMPLETED
|
50
|
45
|
|
3-month Follow-up
NOT COMPLETED
|
3
|
8
|
|
12-month Follow-up
STARTED
|
53
|
53
|
|
12-month Follow-up
COMPLETED
|
37
|
40
|
|
12-month Follow-up
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral + Dilemma Therapy
n=65 Participants
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.
|
Cognitive Behavioral Therapy
n=63 Participants
Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.37 years
STANDARD_DEVIATION 11.22 • n=99 Participants
|
50.06 years
STANDARD_DEVIATION 11.03 • n=107 Participants
|
49.20 years
STANDARD_DEVIATION 11.19 • n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: End of therapy (16 weeks), 3 and 12-month follow-upPopulation: The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified
To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=53 Participants
Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
|
Cognitive Behavioral + Dilemma Therapy
n=53 Participants
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.
|
|---|---|---|
|
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
Baseline
|
36.94 units on a scale
Standard Deviation 9.56
|
37.23 units on a scale
Standard Deviation 8.96
|
|
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
At the end of therapy change from baseline
|
-15.52 units on a scale
Standard Deviation 13.92
|
-17.62 units on a scale
Standard Deviation 12.05
|
|
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
3-month follow-up change from baseline
|
-15.60 units on a scale
Standard Deviation 15.56
|
-15.42 units on a scale
Standard Deviation 13.16
|
|
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
12-month follow-up change from baseline
|
-16.65 units on a scale
Standard Deviation 13.87
|
-19.51 units on a scale
Standard Deviation 13.17
|
SECONDARY outcome
Timeframe: End of therapy and 12-month follow-upPopulation: The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified.
This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=38 Participants
Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
|
Cognitive Behavioral + Dilemma Therapy
n=42 Participants
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.
|
|---|---|---|
|
Change From Baseline in Hamilton-Depression Rating Scale-17 Items
Baseline
|
20.05 units on a scale
Standard Deviation 6.09
|
18.93 units on a scale
Standard Deviation 6.96
|
|
Change From Baseline in Hamilton-Depression Rating Scale-17 Items
At the end of therapy change from baseline
|
-8.84 units on a scale
Standard Deviation 8.28
|
-7.61 units on a scale
Standard Deviation 9.21
|
|
Change From Baseline in Hamilton-Depression Rating Scale-17 Items
12 month follow-up change from baseline
|
-7.89 units on a scale
Standard Deviation 9.57
|
-5.32 units on a scale
Standard Deviation 9.56
|
SECONDARY outcome
Timeframe: End of therapy, 3 and 12 month follow-upPopulation: The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified
To assess subjective well-being, symptoms or problems, life functioning, and risk. The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34). The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.
Outcome measures
| Measure |
Cognitive Behavioral Therapy
n=53 Participants
Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
|
Cognitive Behavioral + Dilemma Therapy
n=53 Participants
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.
|
|---|---|---|
|
Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
12 month follow-up change from baseline
|
-0.58 units on a scale
Standard Deviation 0.86
|
-0.77 units on a scale
Standard Deviation 0.81
|
|
Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
Baseline
|
2.08 units on a scale
Standard Deviation 0.56
|
2.17 units on a scale
Standard Deviation 0.50
|
|
Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
At the end of therapy change from baselina
|
-0.67 units on a scale
Standard Deviation 0.75
|
-0.76 units on a scale
Standard Deviation 0.70
|
|
Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
3 month follow-up change from baseline
|
-0.63 units on a scale
Standard Deviation 0.80
|
-0.59 units on a scale
Standard Deviation 0.76
|
Adverse Events
Cognitive Behavioral + Dilemma Therapy
Cognitive Behavioral Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place