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Behavioral Intervention
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
CBT-I Merit Trial 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.Check my eligibility
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.See study design
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.
CBT-I Merit Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Severity Index (ISI)
Veterans RAND 36-item Health Survey (VR-36)
CBT-I Merit 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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,128 Total Patients Enrolled
26 Trials studying Insomnia
4,041 Patients Enrolled for Insomnia
Elizabeth A. Klingaman, PhDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 Previous Clinical Trials
47 Total Patients Enrolled
1 Trials studying Insomnia
47 Patients Enrolled for Insomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing cognitive behavioral therapy for insomnia.I have been diagnosed with a specific type of mental health disorder, such as schizophrenia or major depression with psychosis.I am between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy-Insomnia
- Group 2: Health and Wellness
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation currently enrolling participants?
"Clinicaltrials.gov confirms that this research project, which was originally posted on November 29th 2021 is actively searching for individuals to participate. Its most recent update occurred on November 21st 2022."
Answered by AI
Is enrollment open to elderly individuals for this experiment?
"This trial seeks participants aged 18 to 80. For those younger than 18, there are 140 clinical trials available and for those older than 65, 432 studies offer potential treatment options."
Answered by AI
What is the scope of participation in this medical experiment?
"Affirmative. According to the data located on clinicaltrials.gov, this medical trial, which was initially uploaded on November 29th 2021, is actively recruiting participants. 156 people need to be recruited from 2 distinct facilities."
Answered by AI
Is it possible for me to take part in this medical experiment?
"To qualify for this trial, applicants must have a diagnosis of psychosis and should be between the ages of 18 to 80. The study is aiming to recruit 156 participants in total."
Answered by AI
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