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Trial record 18 of 51 for:    psychoeducation | Not yet recruiting Studies

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

This study is not yet open for participant recruitment.
Verified November 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02535923
First Posted: August 31, 2015
Last Update Posted: December 4, 2017
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.
Collaborator:
VA Maryland Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Insomnia Psychosis Behavioral: Cognitive Behavioral Therapy-Insomnia Behavioral: Health and Wellness

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Insomnia Severity Index (ISI) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. ]
    Change in the ISI score


Secondary Outcome Measures:
  • 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. ]
    Change in the ISI score

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. ]
    Change in the PSQI score

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 22 weeks. ]
    Change in the PSQI score

  • Veterans RAND 36-Item Health Survey [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. ]
    Change in the Veterans RAND 36-Item Health Survey score

  • Veterans RAND 36-Item Health Survey [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 22 weeks. ]
    Change in the Veterans RAND 36-Item Health Survey score

  • World Health Organization Disability Assessment Schedule (WHO-DAS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. ]
    Change in the WHO-DAS score

  • World Health Organization Disability Assessment Schedule (WHO-DAS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 22 weeks. ]
    Change in the WHO-DAS score

  • Repeatable Battery of Assessment for Neuropsychological Status (RBANS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks. ]
    Change in the RBANS score

  • Repeatable Battery of Assessment for Neuropsychological Status (RBANS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 22 weeks. ]
    Change in the RBANS score


Estimated Enrollment: 60
Anticipated Study Start Date: March 1, 2018
Estimated Study Completion Date: November 1, 2020
Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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): NCT02535923


Contacts
Contact: Elizabeth A Klingaman, PhD (410) 637-1875 Elizabeth.Klingaman@va.gov
Contact: Julia E Kindred, MS (410) 637-1866 julia.kindred@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Elizabeth A Klingaman, PhD    410-637-1875    Elizabeth.Klingaman@va.gov   
Principal Investigator: Elizabeth A. Klingaman, PhD         
Sponsors and Collaborators
VA Office of Research and Development
VA Maryland Health Care System
Investigators
Principal Investigator: Elizabeth A. Klingaman, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02535923     History of Changes
Other Study ID Numbers: D1836-W
1IK2RX001836-01A1 ( U.S. NIH Grant/Contract )
First Submitted: August 26, 2015
First Posted: August 31, 2015
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Schizophrenia and Disorders with Psychotic Feature
Mental Disorders
Insomnia Disorder

Additional relevant MeSH terms:
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