An interventional study of Cognitive Behavioral Social Skills Training (CBSST) and Goal Focused Supportive Contact (GFSC) in Psychotic Disorders, Schizoaffective Disorder and Schizophrenia, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2015-04-06.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
The primary purpose of this project is to evaluate the efficacy of a group therapy intervention, cognitive behavioral social skills training (CBSST), that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to disability in aging veterans with severe mental illness.
This is a randomized-controlled clinical trial comparing 2 treatment conditions: Goal focused supportive care (SC); and CBSST. Subjects (N=100) will be recruited, treated for 9 months and followed longitudinally for 9 months after treatment. A multidimensional evaluation of treatment outcome, including social functioning (primary outcome), neuropsychological functioning, cognitive insight, psychotic symptoms, and health services utilization, will be conducted at baseline, end of treatment (9-month follow-up), and 9 months post-treatment. 100 patients with schizophrenia or schizoaffective disorder will participate on a voluntary basis and will be paid $50.00 per assessment visit. Subjects will not be paid or given any incentive for treatment. The following inclusion/exclusion criteria will be used: (i) Voluntary informed consent for participation (given by the patient or conservator); (ii) Age 45 or older; (iii) DSM-IV-diagnosis (APA, 1994) of schizophrenia or schizoaffective disorder at any stage of illness; (iv) No prior exposure to SST or CBT in the past 5 years; (v) Level of care required at baseline does not interfere with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric, or physical illness). We anticipate that we will be able to provide an empirically validated intervention that can be used by clinicians on multidisciplinary rehabilitation teams to reduce disability in aging patients with schizophrenia. The products from this research will be written research reports and a therapy manual and patient workbook to guide rehabilitation that can be disseminated (e.g., via the internet) to relevant clinicians.
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This study's enrollment of 116 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Exclusion Criteria:
Has not received Cognitive Behavioral Therapy (CBT) or Social Skills Training (SST) or Dialectical Behavioral Therapy (DBT) in the past 5 years
Cognitive Behavioral Social Skills Training (CBSST)
Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
Goal Focused Supportive Contact (GFSC)
Behavioral: Goal Focused Supportive Contact (GFSC)
Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
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 higher level of functioning.
Time frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
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, mid-treatment, end of treatment, mid-follow up, and follow up
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
The 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.
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and followup
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
The 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).
Time frame: baseline, mid treatment, end of treatment, mid follow-up, and follow up
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
The 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).
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Beck Depression Inventory-II (BDI-II)
The 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.
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Beck Anxiety Inventory (BAI)
The 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.
Time frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow up
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.
| Milestone | Cognitive Behavioral Social Skills Training (CBSST) | Goal Focused Supportive Contact (GFSC) |
|---|---|---|
| Started | 41 | 38 |
| Completed | 31 | 33 |
| Not completed | 10 | 5 |
| Withdrew: Baseline and one other ilss required | 10 | 5 |
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.
| units on a scale | Cognitive Behavioral Social Skills Training | Goal Focused Supportive Contact |
|---|---|---|
| Baseline | 0.66 ± 0.09 | 0.70 ± 0.11 |
| Mid-treatment (4.5 months) | 0.68 ± 0.10 | 0.71 ± 0.10 |
| End of treatment (9 months) | 0.68 ± 0.07 | 0.71 ± 0.12 |
| Mid-Followup (13.5 months) | 0.68 ± 0.07 | 0.72 ± 0.12 |
| Follow Up (9 months) | 0.71 ± 0.07 | 0.68 ± 0.13 |
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.
| units on a scale | Cognitive Behavioral Social Skills Training | Goal Focused Supportive Contact |
|---|---|---|
| Baseline | 6.2 ± 3.6 | 4.8 ± 3.3 |
| Mid-treatment (4.5 months) | 8.6 ± 5.6 | 6.2 ± 5.1 |
| End of treatment (9 months) | 12.0 ± 7.1 | 5.5 ± 4.1 |
| Mid-Followup (13.5 months) | 10.5 ± 4.8 | 6.3 ± 4.3 |
| Follow Up (9 months) | 11.2 ± 7.2 | 5.8 ± 3.8 |
The 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.
| units on a scale | Cognitive Behavioral Social Skills Training | Goal Focused Supportive Contact |
|---|---|---|
| Baseline | 18.3 ± 8.1 | 17.8 ± 6.3 |
| Mid-treatment (4.5 months) | 17.4 ± 6.4 | 15.5 ± 5.8 |
| End of treatment (9 months) | 15.5 ± 5.8 | 16.1 ± 5.3 |
| Mid-Followup (13.5 months) | 15.8 ± 6.8 | 18.0 ± 6.7 |
| Follow Up (9 months) | 15.7 ± 5.5 | 18.5 ± 8.1 |
The 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).
| units on a scale | Cognitive Behavioral Social Skills Training | Goal Focused Supportive Contact |
|---|---|---|
| Baseline | 1.63 ± 1.37 | 1.79 ± 1.09 |
| Mid-treatment (4.5 months) | 1.72 ± 1.13 | 1.48 ± 0.87 |
| End of treatment (9 months) | 1.21 ± 1.12 | 1.38 ± 1.04 |
| Mid-Followup (13.5 months) | 1.71 ± 1.00 | 1.62 ± 1.31 |
| Follow Up (9 months) | 1.62 ± 1.06 | 1.83 ± 1.30 |
The 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).
| units on a scale | Cognitive Behavioral Social Skills Training | Goal Focused Supportive Contact |
|---|---|---|
| Baseline | 2.02 ± 1.17 | 2.46 ± 1.15 |
| Mid-treatment (4.5 months) | 2.09 ± 1.35 | 2.15 ± 1.18 |
| End of treatment (9 months) | 1.90 ± 1.30 | 1.83 ± 1.31 |
| Mid-Followup (13.5 months) | 1.53 ± 1.03 | 1.92 ± 1.43 |
| Follow Up (9 months) | 1.72 ± 1.02 | 1.93 ± 1.44 |
The 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.
| units on a scale | Cognitive Behavioral Social Skills Training | Goal Focused Supportive Contact |
|---|---|---|
| Baseline | 16.3 ± 9.8 | 16.4 ± 13.5 |
| Mid-treatment (4.5 months) | 17.2 ± 12.3 | 13.8 ± 11.2 |
| End of treatment (9 months) | 15.0 ± 12.6 | 14.3 ± 14.0 |
| Mid-Followup (13.5 months) | 9.1 ± 7.9 | 12.9 ± 12.7 |
The 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.
| units on a scale | Cognitive Behavioral Social Skills Training | Goal Focused Supportive Contact |
|---|---|---|
| Baseline | 16.4 ± 12.7 | 14.5 ± 12.1 |
| Mid-treatment (4.5 months) | 14.2 ± 12.3 | 12.4 ± 12.1 |
| End of treatment (9 months) | 15.7 ± 14.2 | 10.6 ± 10.1 |
| Mid-Followup (13.5 months) | 12.3 ± 12.2 | 10.5 ± 11.4 |
| Follow Up (9 months) | 11.5 ± 10.1 | 10.4 ± 11.0 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBSST | — | 4/41 (9.8%) | 0/41 (0%) |
| Goal Directed Supportive Care | — | 11/38 (28.9%) | 0/38 (0%) |
| Event | CBSST | Goal Directed Supportive Care |
|---|---|---|
| HospitalizationPsychiatric disorders | 2/41 | 9/38 |
| HospitalizationCardiac disorders | 0/41 | 1/38 |
| HospitalizationSkin and subcutaneous tissue disorders | 0/41 | 1/38 |
| HospitalizationRespiratory, thoracic and mediastinal disorders | 0/41 | 1/38 |
| HospitalizationEndocrine disorders | 1/41 | 0/38 |
| HospitalizationNervous system disorders | 1/41 | 0/38 |
Participants numbers reported include at least one baseline and at least 1 ILSS assesssment
| Age, Customized(participants) | Cognitive Behavioral Social Skills Training (CBSST) | Goal Focused Supportive Contact (GFSC) | Total |
|---|---|---|---|
| Between ages 45 to 78 | 31 | 33 | 64 |
| Sex: Female, Male(Participants) | Cognitive Behavioral Social Skills Training (CBSST) | Goal Focused Supportive Contact (GFSC) | Total |
|---|---|---|---|
| Female | 15 | 19 | 34 |
| Male | 16 | 14 | 30 |
| Region of Enrollment(participants) | Cognitive Behavioral Social Skills Training (CBSST) | Goal Focused Supportive Contact (GFSC) | Total |
|---|---|---|---|
| United States | 31 | 33 | 64 |
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US Department of Veterans Affairs