Trial Summary
What is the purpose of this trial?This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.
Is the treatment Brief Behavioral Treatment for Insomnia (BBTI) and Progressive Muscle Relaxation Training (PMRT) promising for insomnia in PTSD?Yes, BBTI and PMRT are promising treatments for insomnia in PTSD. BBTI has been shown to improve sleep and reduce trauma-related nightmares in veterans. It is recommended as a first-line treatment for insomnia and has been found to be effective in improving psychosocial functioning and reducing insomnia severity.34578
What safety data exists for behavioral treatment for insomnia in PTSD?The available research on Brief Behavioral Treatment for Insomnia (BBTI) indicates that it is an effective treatment for insomnia, particularly in older adults and veterans. The studies highlight its efficacy in improving sleep and psychosocial functioning, with no specific safety concerns reported. BBTI is recommended as a first-line treatment for insomnia by the VA/DoD Clinical Practice Guideline, suggesting it is considered safe for use in military populations. However, the research does not explicitly address safety data for PTSD patients, so further investigation may be needed for this specific group.12568
What data supports the idea that Behavioral Treatment for Insomnia in PTSD is an effective treatment?The available research shows that Behavioral Treatment for Insomnia in PTSD, specifically Brief Behavioral Treatment for Insomnia (BBTI), is effective. One study found that BBTI improved psychosocial functioning in veterans with insomnia. Another study showed that BBTI decreased the frequency of trauma-related nightmares, which are common in PTSD. Additionally, BBTI was found to be as effective as Cognitive Behavioral Therapy for Insomnia (CBTI) in reducing insomnia severity, but with fewer sessions needed. This makes BBTI a practical and efficient option for treating insomnia in PTSD.14578
Do I have to stop taking my current medications for the trial?No, you don't have to stop taking your current medications. You must be stable on them for at least one month and not make any changes during the active treatment phase of the study.
Eligibility Criteria
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.Treatment Details
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.
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).
Brief Behavioral Treatment for Insomnia (BBTI) is already approved in United States for the following indications:
🇺🇸 Approved in United States as BBTI for:
- Insomnia
- Insomnia comorbid with psychiatric, medical, or sleep disorders
- Posttraumatic Stress Disorder (PTSD)
Find a clinic near you
Research locations nearbySelect from list below to view details:
San Francisco VA Medical Center, San Francisco, CASan Francisco, CA
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
References
Clinical management of insomnia with brief behavioral treatment (BBTI). [2022]Insomnia is a highly prevalent and debilitating sleep disorder. It is well documented that psychological treatments, including cognitive-behavioral therapy for insomnia (CBTI), are efficacious treatments, with effect sizes of comparable magnitude to that of pharmacologic treatment. However, a critical shortage of specialty-trained clinicians with experience in sleep medicine and cognitive-behavioral therapy principles has limited the widespread dissemination of CBTI. A brief (four sessions; two of which may be phone sessions) treatment, titled "Brief Behavioral Treatment for Insomnia" (BBTI), was developed to address many of the barriers to widespread dissemination associated with standard CBTI. Specifically, BBTI has an explicit behavioral focus, is overtly linked to a physiological model of sleep regulation, and utilizes a hardcopy workbook that facilitates its concise delivery format and ease of training clinicians. BBTI has demonstrated efficacy in treating older adults with insomnia ( Buysse et al., 2011 ). This article describes the rationale for the development of BBTI, provides a session-by-session guide to the delivery of the treatment, and concludes with a discussion of contraindications, combined pharmacotherapy treatment, and future directions for the use of BBTI in diverse populations and utilizing different modalities of delivery.
Brief behavioral treatment for patients with treatment-resistant insomnia. [2020]To evaluate the efficacy of brief behavioral treatment for insomnia (BBTI) in treating patients with treatment-resistant insomnia.
The impact of prolonged exposure on sleep and enhancing treatment outcomes with evidence-based sleep interventions: A pilot study. [2021]Insomnia and nightmares are central features of posttraumatic stress disorder (PTSD). However, often they are inadequately assessed and ineffectively resolved following gold-standard PTSD treatment. Here we: (a) evaluate effects of prolonged exposure (PE) on subjectively measured sleep and (b) present pilot results of an examination of whether adding sleep interventions (imagery rehearsal therapy [IRT] and cognitive-behavioral therapy for insomnia [CBT-I]) to PE improves treatment response, relative to PE alone, for night- and/or daytime PTSD symptoms among returning U.S. veterans and postdeployment personnel.
Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. [2023]The goal of this study was to compare a brief behavioral treatment for insomnia (BBTI), which has fewer sessions (4), shorter duration (
Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. [2021]Our goal was to compare brief behavioral treatment for insomnia (BBTI) to a progressive muscle relaxation training (PMRT) control condition among veterans with insomnia, examining psychosocial functioning as a primary outcome and sleep-related outcomes, mood, cognition, and pain as secondary outcomes.
Reducing Barriers to Behavioral Treatments for Insomnia: A Qualitative Examination of Veterans' Perspectives of BBTI. [2022]Objective: Although behavioral treatments are recommended for treating insomnia disorder, these treatments are not the most commonly provided treatments due to numerous barriers (e.g., treatment length, time limitations). Brief Behavioral Treatment for Insomnia (BBTI) was developed, in part, to help overcome these barriers. The purpose of the current study was to qualitatively examine the treatment experiences of veterans with insomnia disorder participating in BBTI.Methods: All veterans (n=46) who were randomized to receive BBTI as part of a randomized clinical trial participated in 10-20 minute semi-structured interviews one week after completing treatment. Rapid analysis procedures were used for qualitative analysis.Results: Thirteen qualitative themes were identified: BBTI provided veterans with the skills they believed they needed to continue improving independently post-treatment; beginning BBTI with in-person sessions was valued; phone sessions helped participation; veterans did not perceive that they could cover the same content during phone and in-person sessionsl; materials could be more portable; BBTI created accountability; BBTI required discipline and willingness; BBTI facilitated buy-in; BBTI was aligned with military culture; loved ones could provide important support; BBTI could be improved with more personalization; BBTI challenged expectations of mental health; and BBTI improved awareness of health behaviors beyond sleep.Conclusions: BBTI was successful in overcoming barriers to behavioral insomnia treatment and interviews identified critical treatment aspects that should be maintained to preserve acceptability (e.g., in-person session first). Areas in which BBTI did not fully meet the needs of veterans and targets for improvement (e.g., ameliorating understanding and expectations of phone sessions) were also identified.
Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. [2023]Trauma-related nightmares are highly prevalent among veterans and are associated with higher-severity insomnia and posttraumatic stress disorder. Cognitive behavioral therapy for insomnia (typically 6-8 sessions) has been shown to reduce trauma-related nightmares. Brief behavioral treatment for insomnia (BBTI, 4 sessions) has been found to be comparable to CBT-I in decreasing insomnia severity; however, the effects of BBTI on nightmares have not been investigated. The current study tested the effects of BBTI on both trauma-related nightmares and nontrauma-related bad dreams using an active control group treated using progressive muscle relaxation therapy. In addition, we tested whether baseline trauma-related nightmare frequency and baseline nontrauma-related bad dream frequency moderated changes in insomnia severity.
Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. [2023]Insomnia affects approximately 40% of active duty service members and adversely affects health, readiness, and safety. The VA/DoD Clinical Practice Guideline for the management of insomnia recommends cognitive-behavioral treatment of insomnia (CBTI) or its abbreviated version (brief behavioral treatment of insomnia [BBTI]) as the first-line insomnia treatment. The goal of this study was to assess CBTI/BBTI resources at MTFs, perceived facilitators and barriers for CBTI/BBTI, and gaps in these treatments across the Defense Health Agency.