CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes

Not Applicable

Completed

Brief Summary: The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.

Detailed Description: The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.

Specific Aim 1: Develop empirically-derived guidelines for the clinical tailoring of CBT-I materials and procedures for Veterans with psychotic disorders through an iterative process with input from Veteran clients, CBT-I experts and providers, as well as those with expertise in psychotic disorders.

Specific Aim 2: Establish the acceptability of CBT-I for Veterans with psychotic disorders and insomnia when delivered using guidelines developed in Specific Aim 1 in order to make further refinements to the guidelines in a preliminary trial with 6 Veterans with psychosis and insomnia.

Specific Aim 3: Conduct a randomized controlled trial (n=60) to test the feasibility and preliminary efficacy of CBT-I in producing positive changes at post-treatment and 3-month follow-up on the outcomes of insomnia symptoms, sleep quality, and functioning.

Recruitment & Eligibility

Inclusion Criteria

Diagnostic and Statistical Manual of Disorders, 5th edition (DSM 5) diagnosis of schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34).
Self-reported symptoms of insomnia via an Insomnia Severity Index (ISI) score of 15 or greater.
Age between 18 and 80 as determined by medical record review.
Participation in outpatient mental health services at a designated study site.
Sufficient clinical stability to participate as deemed by a treatment provider.
Capacity to sign Informed Consent.

Exclusion Criteria

Current problematic drug or alcohol use that impacts functioning and study engagement, as deemed by a treatment provider.
Currently in CBT-I treatment, determined by medical records.
Positive screen for sleep apnea via a portable sleep apnea screening device or a prior diagnosis of sleep apnea in medical records.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.	ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.

Secondary Outcome Measures

Name	Time	Method
Veterans RAND 36-Item Health Survey Mental Component Score	Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.	Veterans RAND 36-Item Health Survey Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental health quality of life.
Insomnia Severity Index (ISI)	Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.	ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale	Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.	WHO-DAS score; scores range from 0 to 100 where 100 is full disability.

Locations (1): Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Baltimore, Maryland, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
🇺🇸Baltimore, Maryland, United States