Aging, Schizophrenia
Conditions
Keywords
Cognitive Behavioral Therapy, Social Skills Training, Experience Sampling Method, Computer-assisted therapy, schizophrenia
Brief summary
Aging and psychosis are major priority areas for VA. This project is a continuation of a Merit Review Program, in which we developed, manualized and conducted randomized controlled trials of a novel psychosocial rehabilitation intervention for older people with schizophrenia, called cognitive-behavioral social skills training (CBSST). We found that CBSST improved community functioning in these patients. CBSST, however, is an intensive program that would burden VA mental health clinics with demands for additional staff and financial resources and burdens older veterans with travel and time demands. To reduce these burdens and barriers to implementation of CBSST, we are developing a computer-assisted CBSST intervention that takes advantage of available handheld computer technology. Therapist contact is cut 50% and replaced by handheld computer-assisted CBSST intervention tools. The project will examine whether computer-assisted CBSST is as effective as the full CBSST program, while improving client satisfaction and reducing burden and cost.
Detailed description
Aging and psychosis are major priority areas for VA. This project is a continuation of a Merit Review Program, in which we developed, manualized and conducted randomized controlled trials of a novel psychosocial rehabilitation intervention for older people with schizophrenia, called cognitive-behavioral social skills training (CBSST). We found that CBSST improved community functioning in these patients. CBSST, however, is an intensive program that may burden VA mental health clinics with demands for additional staff and financial resources and Veterans with travel and time demands. To reduce these burdens and barriers to implementation of CBSST, we developed a computer-assisted CBSST intervention that takes advantage of available handheld computer technology (personal data assistants or PDAs). Therapist contact is cut 50% and replaced by handheld computer-assisted CBSST intervention tools. The project will examine whether computer-assisted CBSST is as effective as the full CBSST program, while improving client satisfaction and reducing burden and cost. A randomized-controlled clinical trial comparing 3 treatment conditions (computer-assisted CBSST, CBSST, and a PDA-only control condition) will be conducted. Participants will be recruited, treated for 6 months and followed longitudinally for 6 months after treatment. A multidimensional evaluation of treatment outcome, including functioning (primary outcome), CBSST skills acquisition, and symptoms will be conducted at baseline, mid-treatment, end of treatment (6-months after baseline), and 6-month follow-up (12 months after baseline). Factors that might mediate improvement in CBSST will be assessed, including homework adherence, cognitive insight (metacognition and belief flexibility), and defeatist performance beliefs (e.g., Why try, I'll just fail again). The proposed project will also use innovative computer-assisted Ecological Momentary Assessment (EMAc) methods to measure outcomes. EMAc is an ambulatory data collection technique that permits the real time, real world monitoring of behaviors, moods, and cognitions. Participants are signaled by handheld computers several times throughout the day to respond to questionnaires, which eliminates recall and information-processing biases that can compromise the validity of traditional self-report and interview measures. Outcomes in the proposed trial will be assessed using traditional measures, as well as EMAc measures. Specific Aims: (1) To determine whether computer-assisted CBSST is as effective as the full CBSST program (in prior project) and supportive contact, despite reduced burden and cost. (2) To examine whether EMAc measures of functioning and psychotic symptoms are sensitive to change in CBSST. (3) To examine whether increased cognitive insight, reduced defeatist performance beliefs, and greater homework adherence mediate outcomes in CBSST.
Interventions
BEHAVIORALCBSST+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.
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.
BEHAVIORALPDA-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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Schizophrenia or Schizoaffective Disorder and age \>45 (Veterans and non-Veterans) * fluency in English * Medical, psychiatric and substance abuse sufficiently stable for outpatient group therapy
Exclusion criteria
* prior exposure to CBST during the previous 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independent Living Skills Survey (ILSS) | Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Module Test (CMT) | 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. |
| Positive and Negative Syndrome Scale (PANSS) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 26 |
| 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. | 14 |
| Total | 57 |
Baseline characteristics
| Characteristic | CBSST+PDA | CBSST | PDA-Only | Total |
|---|---|---|---|---|
| Age, Customized Age 45 and older | 17 participants | 26 participants | 14 participants | 57 participants |
| Region of Enrollment United States | 17 participants | 26 participants | 14 participants | 57 participants |
| Sex: Female, Male Female | 1 Participants | 8 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 16 Participants | 18 Participants | 13 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 30 | 0 / 25 |
| serious Total, serious adverse events | 0 / 22 | 4 / 30 | 0 / 25 |
Outcome results
Primary
Independent Living Skills Survey (ILSS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBSST+PDA | Independent Living Skills Survey (ILSS) | Baseline | 0.69 units on a scale | Standard Deviation 0.1 |
| CBSST+PDA | Independent Living Skills Survey (ILSS) | 3 months | 0.69 units on a scale | Standard Deviation 0.1 |
| CBSST+PDA | Independent Living Skills Survey (ILSS) | 6 months | 0.71 units on a scale | Standard Deviation 0.1 |
| CBSST+PDA | Independent Living Skills Survey (ILSS) | 12 months | 0.67 units on a scale | Standard Deviation 0.14 |
| CBSST | Independent Living Skills Survey (ILSS) | 12 months | 0.71 units on a scale | Standard Deviation 0.9 |
| CBSST | Independent Living Skills Survey (ILSS) | Baseline | 0.67 units on a scale | Standard Deviation 0.09 |
| CBSST | Independent Living Skills Survey (ILSS) | 6 months | 0.70 units on a scale | Standard Deviation 0.09 |
| CBSST | Independent Living Skills Survey (ILSS) | 3 months | 0.69 units on a scale | Standard Deviation 0.09 |
| PDA-Only | Independent Living Skills Survey (ILSS) | 12 months | 0.70 units on a scale | Standard Deviation 0.13 |
| PDA-Only | Independent Living Skills Survey (ILSS) | 3 months | 0.73 units on a scale | Standard Deviation 0.1 |
| PDA-Only | Independent Living Skills Survey (ILSS) | 6 months | 0.69 units on a scale | Standard Deviation 0.12 |
| PDA-Only | Independent Living Skills Survey (ILSS) | Baseline | 0.71 units on a scale | Standard Deviation 0.1 |
Secondary
Comprehensive Module Test (CMT)
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.
Time frame: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBSST+PDA | Comprehensive Module Test (CMT) | 6 months | 8.4 units on a scale | Standard Deviation 5.7 |
| CBSST+PDA | Comprehensive Module Test (CMT) | Baseline | 4.3 units on a scale | Standard Deviation 3.6 |
| CBSST+PDA | Comprehensive Module Test (CMT) | 12 months | 4.3 units on a scale | Standard Deviation 2.7 |
| CBSST+PDA | Comprehensive Module Test (CMT) | 3 months | 4.3 units on a scale | Standard Deviation 3.6 |
| CBSST | Comprehensive Module Test (CMT) | 6 months | 11.0 units on a scale | Standard Deviation 5.3 |
| CBSST | Comprehensive Module Test (CMT) | 3 months | 5.8 units on a scale | Standard Deviation 2.9 |
| CBSST | Comprehensive Module Test (CMT) | Baseline | 5.8 units on a scale | Standard Deviation 2.9 |
| CBSST | Comprehensive Module Test (CMT) | 12 months | 9.1 units on a scale | Standard Deviation 5.8 |
| PDA-Only | Comprehensive Module Test (CMT) | 3 months | 3.9 units on a scale | Standard Deviation 3.5 |
| PDA-Only | Comprehensive Module Test (CMT) | Baseline | 3.9 units on a scale | Standard Deviation 3.5 |
| PDA-Only | Comprehensive Module Test (CMT) | 12 months | 1.7 units on a scale | Standard Deviation 2.1 |
| PDA-Only | Comprehensive Module Test (CMT) | 6 months | 3.3 units on a scale | Standard Deviation 2.3 |
Secondary
Positive and Negative Syndrome Scale (PANSS)
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.
Time frame: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBSST+PDA | Positive and Negative Syndrome Scale (PANSS) | Baseline | 68.6 units on a scale | Standard Deviation 22.3 |
| CBSST+PDA | Positive and Negative Syndrome Scale (PANSS) | 3 months | 66.8 units on a scale | Standard Deviation 19.4 |
| CBSST+PDA | Positive and Negative Syndrome Scale (PANSS) | 6 months | 62.2 units on a scale | Standard Deviation 18.5 |
| CBSST+PDA | Positive and Negative Syndrome Scale (PANSS) | 12 months | 63.5 units on a scale | Standard Deviation 19.9 |
| CBSST | Positive and Negative Syndrome Scale (PANSS) | 12 months | 61.8 units on a scale | Standard Deviation 21.4 |
| CBSST | Positive and Negative Syndrome Scale (PANSS) | Baseline | 72.0 units on a scale | Standard Deviation 25.4 |
| CBSST | Positive and Negative Syndrome Scale (PANSS) | 6 months | 61.0 units on a scale | Standard Deviation 17.8 |
| CBSST | Positive and Negative Syndrome Scale (PANSS) | 3 months | 65.3 units on a scale | Standard Deviation 24.9 |
| PDA-Only | Positive and Negative Syndrome Scale (PANSS) | 12 months | 68.0 units on a scale | Standard Deviation 13.7 |
| PDA-Only | Positive and Negative Syndrome Scale (PANSS) | 3 months | 58.2 units on a scale | Standard Deviation 17.9 |
| PDA-Only | Positive and Negative Syndrome Scale (PANSS) | 6 months | 62.9 units on a scale | Standard Deviation 17.3 |
| PDA-Only | Positive and Negative Syndrome Scale (PANSS) | Baseline | 70.6 units on a scale | Standard Deviation 20.9 |