CBT-I to Improve Functional Outcomes in Veterans With Psychosis

NCT04646200 | Active Not Recruiting

• 2 other identifiers: D3213-RI01RX003213
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

Insomnia; Psychosis

Keywords

Mental Disorders; Insomnia Disorder; Psychosis

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index (ISI)

  Change in the ISI score; higher scores signify greater insomnia severity; scores range from 0 to 28.

  Participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months.

• Veterans RAND 36-item Health Survey (VR-36)

  Change in the VR-36 score; higher scores signify a more favorable health state; scores range from 0 to 100.

  Participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months.

Study Arms (2)

Cognitive Behavioral Therapy-Insomnia

EXPERIMENTAL

CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.

Behavioral: Cognitive Behavioral Therapy-Insomnia

Health and Wellness

ACTIVE COMPARATOR

Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).

Behavioral: Health and Wellness

Interventions

Cognitive Behavioral Therapy-Insomnia BEHAVIORAL

CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.

Cognitive Behavioral Therapy-Insomnia

Health and Wellness BEHAVIORAL

Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).

Health and Wellness

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychotic Disorders; Mental Disorders

Interventions

Health

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Elizabeth A. Klingaman, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: November 29, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)