Trial Outcomes & Findings for Functional Rehabilitation of Older Patients With Schizophrenia (NCT NCT00237796)
NCT ID: NCT00237796
Last Updated: 2015-04-06
Results Overview
The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.
COMPLETED
NA
116 participants
baseline, mid-treatment, end of treatment, mid-follow up, and follow up
2015-04-06
Participant Flow
Participants included 79 middle age and older community dwelling Veteran and non-veterans. Inclusion criteria: diagnosis of schizophrenia or schizoaffective, age 45 or older, and fluency in English. Exclusion criteria: prior exposure to CBT during the previous five years.
Baseline data were collected before randomization. N=116 participants enrolled in the study and N=79 started. Total of 37 excluded for reasons: n=20 lost interest; n=6 wrong diagnosis, n=3 not psychiatrically stable; n=3 not medically stable, and n=5 lost contact/moved.
Participant milestones
| Measure |
Cognitive Behavioral Social Skills Training (CBSST)
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact (GFSC)
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
38
|
|
Overall Study
COMPLETED
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Social Skills Training (CBSST)
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact (GFSC)
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Overall Study
Baseline and one other ILSS required
|
10
|
5
|
Baseline Characteristics
Functional Rehabilitation of Older Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Social Skills Training (CBSST)
n=31 Participants
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact (GFSC)
n=33 Participants
Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between ages 45 to 78
|
31 participants
n=39 Participants
|
33 participants
n=41 Participants
|
64 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=39 Participants
|
33 participants
n=41 Participants
|
64 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: baseline, mid-treatment, end of treatment, mid-follow up, and follow upThe ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.
Outcome measures
| Measure |
Cognitive Behavioral Social Skills Training
n=31 Participants
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact
n=33 Participants
Goal Focused Supportive Contact
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Independent Living Skills Survey (ILSS)
Baseline
|
0.66 units on a scale
Standard Deviation 0.09
|
0.70 units on a scale
Standard Deviation 0.11
|
|
Independent Living Skills Survey (ILSS)
Mid-Followup (13.5 months)
|
0.68 units on a scale
Standard Deviation 0.07
|
0.72 units on a scale
Standard Deviation 0.12
|
|
Independent Living Skills Survey (ILSS)
Mid-treatment (4.5 months)
|
0.68 units on a scale
Standard Deviation 0.10
|
0.71 units on a scale
Standard Deviation 0.10
|
|
Independent Living Skills Survey (ILSS)
End of treatment (9 months)
|
0.68 units on a scale
Standard Deviation 0.07
|
0.71 units on a scale
Standard Deviation 0.12
|
|
Independent Living Skills Survey (ILSS)
Follow Up (9 months)
|
0.71 units on a scale
Standard Deviation 0.07
|
0.68 units on a scale
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: baseline, mid-treatment, end of treatment, mid-follow up, and follow upThe Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.
Outcome measures
| Measure |
Cognitive Behavioral Social Skills Training
n=31 Participants
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact
n=33 Participants
Goal Focused Supportive Contact
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Comprehensive Module Test (CMT)
End of treatment (9 months)
|
12.0 units on a scale
Standard Deviation 7.1
|
5.5 units on a scale
Standard Deviation 4.1
|
|
Comprehensive Module Test (CMT)
Mid-Followup (13.5 months)
|
10.5 units on a scale
Standard Deviation 4.8
|
6.3 units on a scale
Standard Deviation 4.3
|
|
Comprehensive Module Test (CMT)
Follow Up (9 months)
|
11.2 units on a scale
Standard Deviation 7.2
|
5.8 units on a scale
Standard Deviation 3.8
|
|
Comprehensive Module Test (CMT)
Baseline
|
6.2 units on a scale
Standard Deviation 3.6
|
4.8 units on a scale
Standard Deviation 3.3
|
|
Comprehensive Module Test (CMT)
Mid-treatment (4.5 months)
|
8.6 units on a scale
Standard Deviation 5.6
|
6.2 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: baseline, mid-treatment, end of treatment, mid follow-up, and followupThe PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility. Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms.
Outcome measures
| Measure |
Cognitive Behavioral Social Skills Training
n=31 Participants
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact
n=33 Participants
Goal Focused Supportive Contact
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Baseline
|
18.3 units on a scale
Standard Deviation 8.1
|
17.8 units on a scale
Standard Deviation 6.3
|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Mid-treatment (4.5 months)
|
17.4 units on a scale
Standard Deviation 6.4
|
15.5 units on a scale
Standard Deviation 5.8
|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
End of treatment (9 months)
|
15.5 units on a scale
Standard Deviation 5.8
|
16.1 units on a scale
Standard Deviation 5.3
|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Mid-Followup (13.5 months)
|
15.8 units on a scale
Standard Deviation 6.8
|
18.0 units on a scale
Standard Deviation 6.7
|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Follow Up (9 months)
|
15.7 units on a scale
Standard Deviation 5.5
|
18.5 units on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: baseline, mid treatment, end of treatment, mid follow-up, and follow upThe SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13).
Outcome measures
| Measure |
Cognitive Behavioral Social Skills Training
n=31 Participants
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact
n=33 Participants
Goal Focused Supportive Contact
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
Baseline
|
1.63 units on a scale
Standard Deviation 1.37
|
1.79 units on a scale
Standard Deviation 1.09
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
Mid-treatment (4.5 months)
|
1.72 units on a scale
Standard Deviation 1.13
|
1.48 units on a scale
Standard Deviation 0.87
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
Mid-Followup (13.5 months)
|
1.71 units on a scale
Standard Deviation 1.00
|
1.62 units on a scale
Standard Deviation 1.31
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
Follow Up (9 months)
|
1.62 units on a scale
Standard Deviation 1.06
|
1.83 units on a scale
Standard Deviation 1.30
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
End of treatment (9 months)
|
1.21 units on a scale
Standard Deviation 1.12
|
1.38 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: baseline, mid-treatment, end of treatment, mid follow-up, and follow-upThe SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22).
Outcome measures
| Measure |
Cognitive Behavioral Social Skills Training
n=31 Participants
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact
n=33 Participants
Goal Focused Supportive Contact
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
Baseline
|
2.02 units on a scale
Standard Deviation 1.17
|
2.46 units on a scale
Standard Deviation 1.15
|
|
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
Mid-treatment (4.5 months)
|
2.09 units on a scale
Standard Deviation 1.35
|
2.15 units on a scale
Standard Deviation 1.18
|
|
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
End of treatment (9 months)
|
1.90 units on a scale
Standard Deviation 1.30
|
1.83 units on a scale
Standard Deviation 1.31
|
|
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
Mid-Followup (13.5 months)
|
1.53 units on a scale
Standard Deviation 1.03
|
1.92 units on a scale
Standard Deviation 1.43
|
|
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
Follow Up (9 months)
|
1.72 units on a scale
Standard Deviation 1.02
|
1.93 units on a scale
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: baseline, mid-treatment, end of treatment, mid follow-up, and follow-upThe BDI-II is a self-report measure of depression that consists of 21 questions. The total scale ranges from 0-63. Scores from individual questions are summed to yield a total score. Higher scores represent greater severity of depression.
Outcome measures
| Measure |
Cognitive Behavioral Social Skills Training
n=31 Participants
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact
n=33 Participants
Goal Focused Supportive Contact
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
Baseline
|
16.3 units on a scale
Standard Deviation 9.8
|
16.4 units on a scale
Standard Deviation 13.5
|
|
Beck Depression Inventory-II (BDI-II)
Mid-treatment (4.5 months)
|
17.2 units on a scale
Standard Deviation 12.3
|
13.8 units on a scale
Standard Deviation 11.2
|
|
Beck Depression Inventory-II (BDI-II)
End of treatment (9 months)
|
15.0 units on a scale
Standard Deviation 12.6
|
14.3 units on a scale
Standard Deviation 14.0
|
|
Beck Depression Inventory-II (BDI-II)
Mid-Followup (13.5 months)
|
9.1 units on a scale
Standard Deviation 7.9
|
12.9 units on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: baseline, mid-treatment, end of treatment, mid follow-up, and follow upThe Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions. Scores from individual items are summed to yield a total score. The total score ranges from 0-63. Higher scores represent greater severity of anxiety.
Outcome measures
| Measure |
Cognitive Behavioral Social Skills Training
n=31 Participants
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Focused Supportive Contact
n=33 Participants
Goal Focused Supportive Contact
Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI)
Baseline
|
16.4 units on a scale
Standard Deviation 12.7
|
14.5 units on a scale
Standard Deviation 12.1
|
|
Beck Anxiety Inventory (BAI)
Mid-treatment (4.5 months)
|
14.2 units on a scale
Standard Deviation 12.3
|
12.4 units on a scale
Standard Deviation 12.1
|
|
Beck Anxiety Inventory (BAI)
End of treatment (9 months)
|
15.7 units on a scale
Standard Deviation 14.2
|
10.6 units on a scale
Standard Deviation 10.1
|
|
Beck Anxiety Inventory (BAI)
Mid-Followup (13.5 months)
|
12.3 units on a scale
Standard Deviation 12.2
|
10.5 units on a scale
Standard Deviation 11.4
|
|
Beck Anxiety Inventory (BAI)
Follow Up (9 months)
|
11.5 units on a scale
Standard Deviation 10.1
|
10.4 units on a scale
Standard Deviation 11.0
|
Adverse Events
CBSST
Goal Directed Supportive Care
Serious adverse events
| Measure |
CBSST
n=41 participants at risk
Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
|
Goal Directed Supportive Care
n=38 participants at risk
Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
4.9%
2/41 • Number of events 4 • 3 years
|
23.7%
9/38 • Number of events 18 • 3 years
|
|
Endocrine disorders
Hospitalization
|
2.4%
1/41 • Number of events 1 • 3 years
|
0.00%
0/38 • 3 years
|
|
Cardiac disorders
Hospitalization
|
0.00%
0/41 • 3 years
|
2.6%
1/38 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Hospitalization
|
0.00%
0/41 • 3 years
|
2.6%
1/38 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/41 • 3 years
|
2.6%
1/38 • Number of events 1 • 3 years
|
|
Nervous system disorders
Hospitalization
|
2.4%
1/41 • Number of events 1 • 3 years
|
0.00%
0/38 • 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Eric Granholm, PhD
VA San Diego Healthcare System, San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place