N/A N=47 Randomized Single-blind Treatment

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

Insomnia · Psychosis

Bottom Line

View on ClinicalTrials.gov: NCT02535923 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Insomnia Severity Index (ISI) — 11.6; 15.2 units on a scale — p=.04

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive Behavioral Therapy-Insomnia (Behavioral); Health and Wellness (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Insomnia Severity Index (ISI)	12.4; 13.0	.83
SECONDARY Insomnia Severity Index (ISI)	12.4; 13.0	.83
SECONDARY Veterans RAND 36-Item Health Survey Mental Component Score	48.4; 47.8	.16
SECONDARY Veterans RAND 36-Item Health Survey Mental Component Score	48.4; 47.8	.16
SECONDARY World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale	42.9; 29.6	—
SECONDARY World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale	42.9; 29.6	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02535923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.