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

February 15, 2023 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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).
  2. Self-reported symptoms of insomnia via an Insomnia Severity Index (ISI) score of 15 or greater.
  3. Age between 18 and 80 as determined by medical record review.
  4. Participation in outpatient mental health services at a designated study site.
  5. Sufficient clinical stability to participate as deemed by a treatment provider.
  6. Capacity to sign Informed Consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy-Insomnia
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
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.
Active Comparator: Health and Wellness
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: 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.
Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: 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.
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
Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
Veterans RAND 36-Item Health Survey score Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental quality of life.
Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
Veterans RAND 36-Item Health Survey Mental Component Score
Time Frame: 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.
Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
WHO-DAS score; scores range from 0 to 100 where 100 is full disability.
Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
Time Frame: 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.
Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

VA Maryland Health Care System

Investigators

  • Principal Investigator: Elizabeth A. Klingaman, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

April 20, 2021

Study Completion (Actual)

April 20, 2021

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1836-W
  • 1IK2RX001836-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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