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Active, Not Recruiting

NCT Number: NCT04646200

CBT-I to Improve Functional Outcomes in Veterans With Psychosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 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.

  2. Veterans RAND 36-item Health Survey (VR-36)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Cognitive Behavioral Therapy For Insomnia (CBT-I) to Improve Functional Outcomes in Veterans With Psychosis

Acronym: CBT-I Merit

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2020
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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