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CBT-I to Improve Functional Outcomes in Veterans With Psychosis (CBT-I Merit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04646200
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Psychosis Behavioral: Cognitive Behavioral Therapy-Insomnia Behavioral: Health and Wellness Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy For Insomnia (CBT-I) to Improve Functional Outcomes in Veterans With Psychosis
Actual Study Start Date : November 29, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • meet criteria established by the VA Serious Mental Illness Treatment Research and Evaluation Center:

    • 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)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646200


Contacts
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Contact: Elizabeth A Klingaman, PhD (410) 637-1875 Elizabeth.Klingaman@va.gov

Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Elizabeth A Klingaman, PhD    410-637-1875    Elizabeth.Klingaman@va.gov   
Principal Investigator: Elizabeth A. Klingaman, PhD         
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Philip Gehrman, PhD    215-823-5800 ext 6737    Philip.Gehrman@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Elizabeth A. Klingaman, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04646200    
Other Study ID Numbers: D3213-R
I01RX003213 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Mental Disorders
Insomnia Disorder
Psychosis
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Psychotic Disorders
Mental Disorders
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Schizophrenia Spectrum and Other Psychotic Disorders