CBT-I to Improve Functional Outcomes in Veterans With Psychosis

Not Applicable

Recruiting

• Conditions: Psychosis; Insomnia

• Registration Number: NCT04646200
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia.

Detailed Description

The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia.

Aim 1: Evaluate the efficacy of CBT-I for reducing insomnia severity in Veterans with psychosis and insomnia.

Hypothesis 1: CBT-I participants, as compared to those in an active control condition, will show significantly greater reductions on the Insomnia Severity Index at post-treatment and at a 6-month follow-up.

Aim 2: Evaluate the efficacy of CBT-I for improving the functioning of Veterans with psychosis and insomnia. Hypothesis 2: CBT-I participants, as compared to those in an active control condition, will show significantly greater increases in mental and physical health functioning on the Veterans RAND 36-Item Health Survey at post-treatment and at a 6-month follow-up.

Aim 3: Evaluate the process that underlies the relationship between insomnia severity and functioning in Veterans with psychosis and insomnia.

Hypothesis 3: The effect of CBT-I on mental and physical health functioning at post-treatment will be mediated by reductions in insomnia severity at week 5 of treatment.

Hypothesis 4: The effect of CBT-I on mental and physical health functioning at the 6-month follow-up will be mediated by reductions in insomnia severity at immediate post-treatment.

Exploratory Aim: Explore whether psychiatric symptoms 1) moderate the impact of CBT-I on insomnia and functioning and/or 2) change as a result of participation in CBT-I.

Study Timeline

• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-27
• Study Start: 2021-11-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-02-27
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• meet criteria for SMI: Schizophrenic disorder, affective psychosis, major depression with psychotic features, delusional disorder, brief psychotic disorder, unspecified psychotic disorder, schizotypal personality disorder
• be between the ages of 18 and 80
• be actively participating in outpatient mental health services at designated site

Exclusion Criteria

• currently in CBT-I treatment
• planning to move out of the area during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months.	Change in the ISI score; higher scores signify greater insomnia severity; scores range from 0 to 28.
Veterans RAND 36-item Health Survey (VR-36)	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months.	Change in the VR-36 score; higher scores signify a more favorable health state; scores range from 0 to 100.

Trial Locations

Locations (2)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States