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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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (week 1) to 6-month follow-up--for treatment arm only
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (week 1) to 6-month follow-up--for treatment arm only for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Work and Social Adjustment Scale (WSAS) Change
Secondary study objectives
Insomnia Severity Index (ISI)
Other study objectives
Depressive Symptom Index: Suicidality Subscale (DSI-SS)

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: 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).

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,713 Total Patients Enrolled
Shira Maguen, PhDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
4 Previous Clinical Trials
235 Total Patients Enrolled

Media Library

Brief Behavioral Treatment for Insomnia (BBTI) Clinical Trial Eligibility Overview. Trial Name: NCT05780177 — N/A
Post-Traumatic Stress Disorder Research Study Groups: BBTI, PMRT
Post-Traumatic Stress Disorder Clinical Trial 2023: Brief Behavioral Treatment for Insomnia (BBTI) Highlights & Side Effects. Trial Name: NCT05780177 — N/A
Brief Behavioral Treatment for Insomnia (BBTI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05780177 — N/A
~57 spots leftby Apr 2027
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