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This is a study comparing the benefits of two types of individual psychotherapy (cognitive-behavioral therapy for psychosis and supportive therapy) in symptomatic Veteran outpatients diagnosed with schizophrenia or schizoaffective disorder. Treatment lasted approximately 6 months, with outcome data on symptoms, functioning, and distress levels collected at baseline, post-treatment, and 6 months post -treatment follow-up.
This is a randomized controlled trial comparing 6 months of participation in one of two active treatments, cognitive-behavioral therapy for psychosis or supportive therapy in symptomatic Veterans diagnosed with schizophrenia or schizoaffective disorder who are still symptomatic. Assessments of clinical status and social functioning were obtained at baseline, end of treatment, and 6 month follow-up. We hypothesized that participation in the cognitive-behavioral therapy would lead to greater reductions in symptoms and distress about symptoms, and more improvements in social functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for Psychosis (CBTp) | Experimental | approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals. |
|
| Supportive Therapy (ST) | Active Comparator | approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' lives and concerns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive Therapy (ST) | Behavioral | approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Positive Schizophrenia Symptoms | Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, & Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243 | Pre-treatment to end of treatment, approximately 6 months post-randomization |
| Changes in Positive Schizophrenia Symptoms | Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, & Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243 | Pre-treatment to follow-up, approximately 6 months post end-of-treatment |
| Changes in Global Social Functioning | Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler, Hogarty, Weissman:, 1979) with low scores indicating better functioning Schooler N, Hogarty G,& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303) | Pre-treatment to end of treatment, approximately 6 months post-randomization |
| Changes in Global Social Functioning | Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler N, Hogarty G, Weissman M:, 1979) with low scores indicating better functioning Schooler N, Hogarty G,& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Distress From Schizophrenia Symptoms | Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirley M. Glynn, PhD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
De-identified data on major outcomes can be shared. Investigators can contact PI.
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122 individuals consented for study; 34 did not meet study criteria after more careful screening during baseline phase or withdrew before baseline assessments were completed; Remaining 88 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-behavioral Therapy for Psychosis (CBTp) | approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery |
| FG001 | Supportive Therapy (ST) | approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Therapy for Psychosis (CBTp) | approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Positive Schizophrenia Symptoms | Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, & Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243 | Posted | Least Squares Mean | Standard Error | units on a scale | Pre-treatment to end of treatment, approximately 6 months post-randomization |
|
Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive-behavioral Therapy for Psychosis (CBTp) | approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization Due to Psychiatric Symptom Exacerbation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shirley M. Glynn, Ph.D. | VA Greater Los Angeles Healthcare System at West Los Angeles | 3102683939 | shirley.glynn@va.gov |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Cognitive Behavioral Therapy for Psychosis (CBTp) | Behavioral | approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery |
|
| Pre-treatment to follow-up, approximately 6 months post end-of-treatment |
| Pre-treatment to end-of-treatment, approximately 6 months post-randomization |
| Changes in Distress From Schizophrenia Symptoms | Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889. | Pre-treatment to follow-up, approximately 6 months post end-of-treatment |
| Withdrawal by Subject |
|
| Declined Interview |
|
| Hospitalized at Follow-up |
|
| BG001 | Supportive Therapy (ST) | approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of years since first began experiencing symptoms (self-report) | Mean | Standard Deviation | years |
|
| OG001 | Supportive Therapy (ST) | approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery |
|
|
|
| Primary | Changes in Positive Schizophrenia Symptoms | Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, & Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243 | Posted | Least Squares Mean | Standard Error | units on a scale | Pre-treatment to follow-up, approximately 6 months post end-of-treatment |
|
|
|
|
| Primary | Changes in Global Social Functioning | Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler, Hogarty, Weissman:, 1979) with low scores indicating better functioning Schooler N, Hogarty G,& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303) | Posted | Least Squares Mean | Standard Error | units on a scale | Pre-treatment to end of treatment, approximately 6 months post-randomization |
|
|
|
|
| Primary | Changes in Global Social Functioning | Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler N, Hogarty G, Weissman M:, 1979) with low scores indicating better functioning Schooler N, Hogarty G,& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303) | Posted | Least Squares Mean | Standard Error | units on a scale | Pre-treatment to follow-up, approximately 6 months post end-of-treatment |
|
|
|
|
| Secondary | Changes in Distress From Schizophrenia Symptoms | Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889. | Posted | Least Squares Mean | Standard Error | units on a scale | Pre-treatment to end-of-treatment, approximately 6 months post-randomization |
|
|
|
|
| Secondary | Changes in Distress From Schizophrenia Symptoms | Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889. | Posted | Least Squares Mean | Standard Error | units on a scale | Pre-treatment to follow-up, approximately 6 months post end-of-treatment |
|
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|
|
| 11 |
| 44 |
| 0 |
| 44 |
| EG001 | Supportive Therapy (ST) | approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery | 12 | 44 | 0 | 44 |
| Hospitalization for Cardiac Problems | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization for Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hospitalization for Fainting | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization for Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Surgeries | Surgical and medical procedures | Non-systematic Assessment |
|
| Hospitalization for Medication Adjustment | Psychiatric disorders | Non-systematic Assessment |
|
| Hospitalization for Foot Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hospitalization for Dehydration | Endocrine disorders | Non-systematic Assessment |
|
| Hospitalization for Allergic Reaction | General disorders | Non-systematic Assessment |
|
| Hospitalization for Eye Injury | Eye disorders | Non-systematic Assessment |
|
| Hospitalization For Substance Use | Psychiatric disorders | Non-systematic Assessment |
|
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| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |