Trial Outcomes & Findings for Cognitive-Behavioral Therapy in Veterans With Schizophrenia (NCT NCT00688259)

Last Updated: 2025-04-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

122 participants

Primary outcome timeframe

Pre-treatment to end of treatment, approximately 6 months post-randomization

Results posted on

2025-04-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	44	44
Overall Study End to Active Treatment,	35	37
Overall Study COMPLETED	37	36
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	2	4
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	2	0
Overall Study Declined Interview	2	3
Overall Study Hospitalized at Follow-up	0	1

Baseline Characteristics

Cognitive-Behavioral Therapy in Veterans With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Behavioral Therapy for Psychosis (CBTp) n=44 Participants 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	Supportive Therapy (ST) n=44 Participants 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	Total n=88 Participants Total of all reporting groups
Age, Continuous	50.25 years STANDARD_DEVIATION 9.31 • n=5 Participants	49.07 years STANDARD_DEVIATION 9.63 • n=7 Participants	49.66 years STANDARD_DEVIATION 9.47 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Race/Ethnicity, Customized African- American	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Latino/Hispanic	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Number of years since first began experiencing symptoms (self-report)	24.89 years STANDARD_DEVIATION 10.30 • n=5 Participants	23.22 years STANDARD_DEVIATION 11.65 • n=7 Participants	24.06 years STANDARD_DEVIATION 10.99 • n=5 Participants

PRIMARY outcome

Timeframe: Pre-treatment to end of treatment, approximately 6 months post-randomization

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy for Psychosis (CBTp) n=37 Participants 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. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery	Supportive Therapy (ST) n=37 Participants 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
Changes in Positive Schizophrenia Symptoms Baseline	3.21 units on a scale Standard Error .14	3.30 units on a scale Standard Error .14
Changes in Positive Schizophrenia Symptoms End-of-Active Treatment	3.04 units on a scale Standard Error .15	2.89 units on a scale Standard Error .15

PRIMARY outcome

Timeframe: Pre-treatment to follow-up, approximately 6 months post end-of-treatment

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy for Psychosis (CBTp) n=37 Participants 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. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery	Supportive Therapy (ST) n=36 Participants 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
Changes in Positive Schizophrenia Symptoms Baseline	3.21 units on a scale Standard Error .14	3.30 units on a scale Standard Error .14
Changes in Positive Schizophrenia Symptoms 6 Months Post End-of-Tx Follow-up	3.12 units on a scale Standard Error .15	2.78 units on a scale Standard Error .15

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy for Psychosis (CBTp) n=37 Participants 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. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery	Supportive Therapy (ST) n=37 Participants 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
Changes in Global Social Functioning Baseline	5.00 units on a scale Standard Error .12	4.80 units on a scale Standard Error .12
Changes in Global Social Functioning End of-Active Treatment	4.78 units on a scale Standard Error .13	4.75 units on a scale Standard Error .13

PRIMARY outcome

Timeframe: Pre-treatment to follow-up, approximately 6 months post end-of-treatment

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)

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy for Psychosis (CBTp) n=37 Participants 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. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery	Supportive Therapy (ST) n=36 Participants 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
Changes in Global Social Functioning Pre-treatment	5.00 units on a scale Standard Error .12	4.80 units on a scale Standard Error .12
Changes in Global Social Functioning 6 Months Post End-of-Tx Follow-up	4.63 units on a scale Standard Error .13	4.56 units on a scale Standard Error .14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy for Psychosis (CBTp) n=37 Participants 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. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery	Supportive Therapy (ST) n=37 Participants 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
Changes in Distress From Schizophrenia Symptoms Baseline	40.79 units on a scale Standard Error 2.01	40.70 units on a scale Standard Error 2.03
Changes in Distress From Schizophrenia Symptoms End of-Active Treatment	34.45 units on a scale Standard Error 2.12	36.33 units on a scale Standard Error 2.12

SECONDARY outcome

Timeframe: Pre-treatment to follow-up, approximately 6 months post end-of-treatment

Outcome measures

Outcome measures
Measure	Cognitive-behavioral Therapy for Psychosis (CBTp) n=37 Participants 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. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery	Supportive Therapy (ST) n=36 Participants 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
Changes in Distress From Schizophrenia Symptoms Baseline	40.79 units on a scale Standard Error 2.01	40.70 units on a scale Standard Error 2.03
Changes in Distress From Schizophrenia Symptoms 6 Months Post End of Tx Follow-up	35.43 units on a scale Standard Error 2.15	31.48 units on a scale Standard Error 2.16

Adverse Events

Cognitive-behavioral Therapy for Psychosis (CBTp)

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Supportive Therapy (ST)

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cognitive-behavioral Therapy for Psychosis (CBTp) n=44 participants at risk 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	Supportive Therapy (ST) n=44 participants at risk 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
Psychiatric disorders Hospitalization Due to Psychiatric Symptom Exacerbation	13.6% 6/44 • Number of events 6 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	13.6% 6/44 • Number of events 10 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Cardiac disorders Hospitalization for Cardiac Problems	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	6.8% 3/44 • Number of events 6 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Skin and subcutaneous tissue disorders Hospitalization for Cellulitis	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Cardiac disorders Hospitalization for Fainting	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Nervous system disorders Hospitalization for Seizure	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Surgical and medical procedures Surgeries	4.5% 2/44 • Number of events 3 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Psychiatric disorders Hospitalization for Medication Adjustment	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Injury, poisoning and procedural complications Hospitalization for Foot Injury	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Endocrine disorders Hospitalization for Dehydration	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
General disorders Hospitalization for Allergic Reaction	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Eye disorders Hospitalization for Eye Injury	0.00% 0/44 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	2.3% 1/44 • Number of events 1 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)
Psychiatric disorders Hospitalization For Substance Use	2.3% 1/44 • Number of events 2 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)	6.8% 3/44 • Number of events 5 • Pre-treatment to 6 month post-treatment follow-up (total 12 months post randomization)

Other adverse events

Adverse event data not reported

Additional Information

Shirley M. Glynn, Ph.D.

VA Greater Los Angeles Healthcare System at West Los Angeles

Phone: 3102683939

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place