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Behavioral Treatment for Insomnia in PTSD (BBTI & PTSD Trial)
N/A
Recruiting
Led By Shira Maguen, 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 change from baseline (week 1) to 6-month follow-up--for treatment arm only
Awards & highlights
BBTI & PTSD Trial Summary
This trial will compare two treatments for insomnia in Veterans with PTSD to see if they improve psychosocial functioning and reduce suicidal ideation.
Who is the study for?
Veterans aged 18-75 with PTSD and insomnia can join this study. They must have stable medication for at least a month and not plan changes during the trial. Those in psychotherapy should be steady in their treatment, but cannot start new therapies targeting insomnia or PTSD until after the trial.Check my eligibility
What is being tested?
The study compares Brief Behavioral Treatment for Insomnia (BBTI) to Progressive Muscle Relaxation Training (PMRT) in improving sleep and psychosocial functioning among veterans with PTSD. It also looks at long-term benefits and effects on suicidal thoughts.See study design
What are the potential side effects?
Since BBTI and PMRT are non-pharmacological treatments focusing on behavior modification and relaxation techniques, they typically do not have side effects like medications do; however, individual experiences may vary.
BBTI & PTSD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline (week 1) to 6-month follow-up--for treatment arm only
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (week 1) to 6-month follow-up--for treatment arm only
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Work and Social Adjustment Scale (WSAS) Change
Secondary outcome measures
Insomnia Severity Index (ISI)
Other outcome measures
Depressive Symptom Index: Suicidality Subscale (DSI-SS)
BBTI & PTSD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BBTIExperimental Treatment1 Intervention
Participants in this arm will receive 4 sessions (20-60 minutes) of a brief behavioral treatment for insomnia (BBTI). Relaxation techniques are not a component of BBTI.
Group II: PMRTActive Control1 Intervention
Participants in this arm will receive 4 sessions (20-60 minutes) of progressive muscle relaxation training (PMRT).
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,188 Total Patients Enrolled
Shira Maguen, PhDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
4 Previous Clinical Trials
235 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a military veteran aged between 18 and 75.I have been in psychotherapy for over a month and won't stop during the trial.I am a veteran who has had episodes of psychosis or mania.I have sleep apnea that is either treated or mild and untreated.I have finished or will not start VA-approved treatments for insomnia or PTSD before joining the trial.I am a veteran with a condition like restless legs syndrome that hasn't been treated.I am a veteran with untreated sleep apnea that is not mild.I have been on stable doses of my mental health medications for at least a month.I will wait a month before joining if I plan to start new psychotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: BBTI
- Group 2: PMRT
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.
Am I eligible to be a part of this research program?
"In order to be eligible for the clinical trial, applicants must suffer from insomnia and lie within the age range of 18-75. The total number of participants needed is 96 individuals."
Answered by AI
Is this research endeavor accepting participants who are over the age of thirty?
"For consideration in this medical trial, candidates must be aged 18 to 75. There are 300 studies for minors and 1,013 for seniors."
Answered by AI
Does this experiment have any more participants available to join?
"It appears that clinicaltrials.gov does not list this trial as actively recruiting patients, despite being initially posted on May 1st 2023 and last updated on March 9th 2023. However, 1433 other trials are currently open to participants at the present moment."
Answered by AI
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