CBT for Insomnia in Veterans with Psychosis (CBT-I Merit Trial)

N/A

Recruiting

Led By Elizabeth A. Klingaman, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether CBT-I can help Veterans with psychosis and insomnia sleep better and improve related outcomes.

Who is the study for?

This trial is for Veterans aged 18-80 with serious mental illnesses like schizophrenia, various psychosis disorders, major depression with psychotic features, and schizotypal personality disorder. They must be receiving outpatient mental health services but not currently in CBT-I treatment or planning to move during the study.

What is being tested?

The trial is testing Cognitive Behavioral Therapy for Insomnia (CBT-I) to see if it can improve sleep and day-to-day functioning in Veterans who have both insomnia and psychosis.

What are the potential side effects?

Since CBT-I is a non-medical therapy focusing on changing behavior and thinking patterns related to sleep, it typically does not have physical side effects. However, participants may experience changes in mood or anxiety levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be assessed following completion of the study intervention, an expected average of 12 weeks; and again after approximately 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index (ISI)

Veterans RAND 36-item Health Survey (VR-36)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Behavioral Therapy-InsomniaExperimental Treatment1 Intervention

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.

Group II: Health and WellnessActive Control1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy-Insomnia

2018

N/A

~100

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