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

Insomnia Clinical Trial

— CBT-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535923
• Other study ID #: D1836-W
• Secondary ID: 1IK2RX001836-01A
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: April 20, 2021

Study information

• Verified date: February 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Maryland Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 a second time following completion of the study intervention, an expected average of 22 weeks.
Secondary	Veterans RAND 36-Item Health Survey Mental Component Score	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.
Secondary	Veterans RAND 36-Item Health Survey Mental Component Score	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.
Secondary	World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale	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.
Secondary	World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale	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.