Trial Outcomes & Findings for Functional Rehabilitation for Older Patients With Schizophrenia (NCT NCT00712075)
NCT ID: NCT00712075
Last Updated: 2015-06-01
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 a higher level of functioning.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)
Results posted on
2015-06-01
Participant Flow
Participants included 77 community dwelling Veterans and non-Veterans. Inclusion criteria: diagnosis of schizophrenia or schizoaffective, age 45 or older, fluency in English, and medical, psychiatric and substance abuse sufficiently stable for outpatient group therapy Exclusion criteria: prior exposure to CBT during the previous five years.
107 participants were enrolled in the study and 77 participants started the study. 30 were excluded (lost interest, N=6; Wrong diagnosis, N=10; Early study termination, N=4; Medically unstable, N=2; Psychiatrically unstable, N=4; Prior CBT, N=4).
Participant milestones
| Measure |
CBSST+PDA
PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance.
|
CBSST
Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.
|
PDA-Only
PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
30
|
25
|
|
Overall Study
COMPLETED
|
17
|
26
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Functional Rehabilitation for Older Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
CBSST+PDA
n=17 Participants
PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance.
|
CBSST
n=26 Participants
Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.
|
PDA-Only
n=14 Participants
PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age 45 and older
|
17 participants
n=5 Participants
|
26 participants
n=7 Participants
|
14 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
26 participants
n=7 Participants
|
14 participants
n=5 Participants
|
57 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)Population: Due to incomplete ILSS data for one participant in the CBSST group, 25 of 26 participants were included in the analyses for this measure.
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 a higher level of functioning.
Outcome measures
| Measure |
CBSST+PDA
n=17 Participants
PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance.
|
CBSST
n=25 Participants
Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.
|
PDA-Only
n=14 Participants
PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings.
|
|---|---|---|---|
|
Independent Living Skills Survey (ILSS)
Baseline
|
0.69 units on a scale
Standard Deviation 0.10
|
0.67 units on a scale
Standard Deviation 0.09
|
0.71 units on a scale
Standard Deviation 0.10
|
|
Independent Living Skills Survey (ILSS)
3 months
|
0.69 units on a scale
Standard Deviation 0.10
|
0.69 units on a scale
Standard Deviation 0.09
|
0.73 units on a scale
Standard Deviation 0.10
|
|
Independent Living Skills Survey (ILSS)
6 months
|
0.71 units on a scale
Standard Deviation 0.10
|
0.70 units on a scale
Standard Deviation 0.09
|
0.69 units on a scale
Standard Deviation 0.12
|
|
Independent Living Skills Survey (ILSS)
12 months
|
0.67 units on a scale
Standard Deviation 0.14
|
0.71 units on a scale
Standard Deviation 0.9
|
0.70 units on a scale
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)The 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 |
CBSST+PDA
n=17 Participants
PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance.
|
CBSST
n=26 Participants
Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.
|
PDA-Only
n=14 Participants
PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings.
|
|---|---|---|---|
|
Comprehensive Module Test (CMT)
Baseline
|
4.3 units on a scale
Standard Deviation 3.6
|
5.8 units on a scale
Standard Deviation 2.9
|
3.9 units on a scale
Standard Deviation 3.5
|
|
Comprehensive Module Test (CMT)
3 months
|
4.3 units on a scale
Standard Deviation 3.6
|
5.8 units on a scale
Standard Deviation 2.9
|
3.9 units on a scale
Standard Deviation 3.5
|
|
Comprehensive Module Test (CMT)
6 months
|
8.4 units on a scale
Standard Deviation 5.7
|
11.0 units on a scale
Standard Deviation 5.3
|
3.3 units on a scale
Standard Deviation 2.3
|
|
Comprehensive Module Test (CMT)
12 months
|
4.3 units on a scale
Standard Deviation 2.7
|
9.1 units on a scale
Standard Deviation 5.8
|
1.7 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.
Outcome measures
| Measure |
CBSST+PDA
n=17 Participants
PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance.
|
CBSST
n=26 Participants
Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.
|
PDA-Only
n=14 Participants
PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings.
|
|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
68.6 units on a scale
Standard Deviation 22.3
|
72.0 units on a scale
Standard Deviation 25.4
|
70.6 units on a scale
Standard Deviation 20.9
|
|
Positive and Negative Syndrome Scale (PANSS)
3 months
|
66.8 units on a scale
Standard Deviation 19.4
|
65.3 units on a scale
Standard Deviation 24.9
|
58.2 units on a scale
Standard Deviation 17.9
|
|
Positive and Negative Syndrome Scale (PANSS)
6 months
|
62.2 units on a scale
Standard Deviation 18.5
|
61.0 units on a scale
Standard Deviation 17.8
|
62.9 units on a scale
Standard Deviation 17.3
|
|
Positive and Negative Syndrome Scale (PANSS)
12 months
|
63.5 units on a scale
Standard Deviation 19.9
|
61.8 units on a scale
Standard Deviation 21.4
|
68.0 units on a scale
Standard Deviation 13.7
|
Adverse Events
CBSST+PDA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CBSST
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
PDA-Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CBSST+PDA
n=22 participants at risk
PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.
CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance.
|
CBSST
n=30 participants at risk
Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.
Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.
|
PDA-Only
n=25 participants at risk
PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.
PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings.
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/22
|
13.3%
4/30
|
0.00%
0/25
|
Other adverse events
Adverse event data not reported
Additional Information
Eric Granholm, PhD
VA San Diego Healthcare System, San Diego
Phone: 858-552-8585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place