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

NCT02535923 | Completed Results

• 2 other identifiers: D1836-W1IK2RX001836-01A1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Psychosis

Keywords

Schizophrenia and Disorders with Psychotic Feature; Mental Disorders; Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  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 Outcomes (5)

• Insomnia Severity Index (ISI)

  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

  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

  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

  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

  Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.

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:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Maryland Health Care System: collaborator

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

Related Publications (7)

• Cohrs S. Sleep disturbances in patients with schizophrenia : impact and effect of antipsychotics. CNS Drugs. 2008;22(11):939-62. doi: 10.2165/00023210-200822110-00004.

  PMID: 18840034 BACKGROUND

• Bramoweth AD, Germain A. Deployment-related insomnia in military personnel and veterans. Curr Psychiatry Rep. 2013 Oct;15(10):401. doi: 10.1007/s11920-013-0401-4.

  PMID: 24005883 BACKGROUND

• Klingaman EA, Palmer-Bacon J, Bennett ME, Rowland LM. Sleep Disorders Among People With Schizophrenia: Emerging Research. Curr Psychiatry Rep. 2015 Oct;17(10):79. doi: 10.1007/s11920-015-0616-7.

  PMID: 26279058 BACKGROUND

• Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193.

  PMID: 23423416 BACKGROUND

• Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006 Jan;25(1):3-14. doi: 10.1037/0278-6133.25.1.3.

  PMID: 16448292 BACKGROUND

• Myers E, Startup H, Freeman D. Cognitive behavioural treatment of insomnia in individuals with persistent persecutory delusions: a pilot trial. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):330-6. doi: 10.1016/j.jbtep.2011.02.004. Epub 2011 Mar 2.

  PMID: 21367359 BACKGROUND

• Dopke CA, Lehner RK, Wells AM. Cognitive-behavioral group therapy for insomnia in individuals with serious mental illnesses: a preliminary evaluation. Psychiatr Rehabil J. 2004 Winter;27(3):235-42. doi: 10.2975/27.2004.235.242.

  PMID: 14982330 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychotic Disorders; Schizophrenia; 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

Results Point of Contact

• Title: Elizabeth A Klingaman PhD
• Organization: Department of Veterans Affairs

elizabeth.klingaman@va.gov

410-259-7810

Study Officials

• Elizabeth A. Klingaman, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 26, 2015
• First Posted: August 31, 2015
• Study Start: March 1, 2018
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)