Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
clinical trials, psychotherapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSupportive Therapy (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
BEHAVIORALCognitive Behavioral Therapy for Psychosis (CBTp)
approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* outpatients with schizophrenia or schizoaffective disorder in proximity to the West Los Angeles VAMC * at least one month since last hospitalization * stable antipsychotic medication with persisting psychotic symptoms with at least minimal distress * competent to sign informed consent.
Exclusion criteria
* in other individual psychotherapy * presence of organic brain disease * mental retardation * illness that would prohibit regular attendance in therapy * substance dependence diagnosis in the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Positive Schizophrenia Symptoms | Pre-treatment to end of treatment, approximately 6 months post-randomization | 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 |
| Changes in Global Social Functioning | Pre-treatment to end of treatment, approximately 6 months post-randomization | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Distress From Schizophrenia Symptoms | Pre-treatment to end-of-treatment, approximately 6 months post-randomization | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 44 |
| 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 | 44 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Declined Interview | 2 | 3 |
| Overall Study | Hospitalized at Follow-up | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy for Psychosis (CBTp) | Supportive Therapy (ST) | Total |
|---|---|---|---|
| Age, Continuous | 50.25 years STANDARD_DEVIATION 9.31 | 49.07 years STANDARD_DEVIATION 9.63 | 49.66 years STANDARD_DEVIATION 9.47 |
| Number of years since first began experiencing symptoms (self-report) | 24.89 years STANDARD_DEVIATION 10.3 | 23.22 years STANDARD_DEVIATION 11.65 | 24.06 years STANDARD_DEVIATION 10.99 |
| Race/Ethnicity, Customized African- American | 25 Participants | 24 Participants | 49 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 11 Participants | 15 Participants | 26 Participants |
| Race/Ethnicity, Customized Latino/Hispanic | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 42 Participants | 40 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 11 / 44 | 12 / 44 |
Outcome results
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)
Time frame: Pre-treatment to end of treatment, approximately 6 months post-randomization
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Global Social Functioning | Baseline | 5.00 units on a scale | Standard Error 0.12 |
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Global Social Functioning | End of-Active Treatment | 4.78 units on a scale | Standard Error 0.13 |
| Supportive Therapy (ST) | Changes in Global Social Functioning | Baseline | 4.80 units on a scale | Standard Error 0.12 |
| Supportive Therapy (ST) | Changes in Global Social Functioning | End of-Active Treatment | 4.75 units on a scale | Standard Error 0.13 |
p-value: 0.46Mixed Models Analysis
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)
Time frame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Global Social Functioning | Pre-treatment | 5.00 units on a scale | Standard Error 0.12 |
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Global Social Functioning | 6 Months Post End-of-Tx Follow-up | 4.63 units on a scale | Standard Error 0.13 |
| Supportive Therapy (ST) | Changes in Global Social Functioning | Pre-treatment | 4.80 units on a scale | Standard Error 0.12 |
| Supportive Therapy (ST) | Changes in Global Social Functioning | 6 Months Post End-of-Tx Follow-up | 4.56 units on a scale | Standard Error 0.14 |
p-value: 0.55Mixed Models Analysis
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
Time frame: Pre-treatment to end of treatment, approximately 6 months post-randomization
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Positive Schizophrenia Symptoms | Baseline | 3.21 units on a scale | Standard Error 0.14 |
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Positive Schizophrenia Symptoms | End-of-Active Treatment | 3.04 units on a scale | Standard Error 0.15 |
| Supportive Therapy (ST) | Changes in Positive Schizophrenia Symptoms | Baseline | 3.30 units on a scale | Standard Error 0.14 |
| Supportive Therapy (ST) | Changes in Positive Schizophrenia Symptoms | End-of-Active Treatment | 2.89 units on a scale | Standard Error 0.15 |
p-value: 0.3Mixed Models Analysis
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
Time frame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Positive Schizophrenia Symptoms | Baseline | 3.21 units on a scale | Standard Error 0.14 |
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Positive Schizophrenia Symptoms | 6 Months Post End-of-Tx Follow-up | 3.12 units on a scale | Standard Error 0.15 |
| Supportive Therapy (ST) | Changes in Positive Schizophrenia Symptoms | Baseline | 3.30 units on a scale | Standard Error 0.14 |
| Supportive Therapy (ST) | Changes in Positive Schizophrenia Symptoms | 6 Months Post End-of-Tx Follow-up | 2.78 units on a scale | Standard Error 0.15 |
p-value: 0.09Mixed Models Analysis
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.
Time frame: Pre-treatment to end-of-treatment, approximately 6 months post-randomization
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Distress From Schizophrenia Symptoms | Baseline | 40.79 units on a scale | Standard Error 2.01 |
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Distress From Schizophrenia Symptoms | End of-Active Treatment | 34.45 units on a scale | Standard Error 2.12 |
| Supportive Therapy (ST) | Changes in Distress From Schizophrenia Symptoms | Baseline | 40.70 units on a scale | Standard Error 2.03 |
| Supportive Therapy (ST) | Changes in Distress From Schizophrenia Symptoms | End of-Active Treatment | 36.33 units on a scale | Standard Error 2.12 |
p-value: 0.5Mixed Models Analysis
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.
Time frame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Distress From Schizophrenia Symptoms | Baseline | 40.79 units on a scale | Standard Error 2.01 |
| Cognitive-behavioral Therapy for Psychosis (CBTp) | Changes in Distress From Schizophrenia Symptoms | 6 Months Post End of Tx Follow-up | 35.43 units on a scale | Standard Error 2.15 |
| Supportive Therapy (ST) | Changes in Distress From Schizophrenia Symptoms | Baseline | 40.70 units on a scale | Standard Error 2.03 |
| Supportive Therapy (ST) | Changes in Distress From Schizophrenia Symptoms | 6 Months Post End of Tx Follow-up | 31.48 units on a scale | Standard Error 2.16 |
p-value: 0.25Mixed Models Analysis