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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Insomnia, Psychosis

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy-Insomnia
* Behavioral: Health and Wellness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia and Disorders with Psychotic Feature, Mental Disorders, Insomnia Disorder