Behavioral Treatment for Insomnia in PTSD

(BBTI & PTSD Trial)

Overseen By Joy Huggins, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorder, Manic episodes, Alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores treatments for veterans dealing with both PTSD and insomnia. It compares two approaches: brief behavioral treatment for insomnia (BBTI) and progressive muscle relaxation training (PMRT). The goal is to determine which treatment improves sleep and overall functioning, while assessing the longevity of these benefits and their impact on reducing suicidal thoughts. Veterans diagnosed with both insomnia and PTSD, whose current medications or therapies remain stable, might be suitable candidates for this study. As an unphased trial, it offers veterans the chance to contribute to research that could enhance treatment options for PTSD and insomnia.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications, but you must be stable on them for at least one month and not change them during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Brief Behavioral Treatment for Insomnia (BBTI) and Progressive Muscle Relaxation Training (PMRT) are generally easy for people to handle. Studies on BBTI indicate it improves sleep and mood in veterans with PTSD, with no major side effects reported. BBTI also reduces trauma-related nightmares and helps maintain improvements in social and emotional well-being.

PMRT, in contrast, is commonly used to reduce stress and promote relaxation. It involves tensing and then relaxing different muscle groups to alleviate stress. Research shows that PMRT enhances relaxation and improves mental health and sleep quality, with no serious side effects mentioned.

Both treatments appear safe based on previous research. They focus on improving sleep and reducing stress, which are crucial for those dealing with insomnia and PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for insomnia in PTSD because they offer non-drug approaches that target sleep issues directly. Brief Behavioral Treatment for Insomnia (BBTI) is unique because it uses structured behavioral strategies without relying on relaxation techniques or medication, potentially offering faster relief by focusing on sleep habits. Progressive Muscle Relaxation Training (PMRT), on the other hand, emphasizes physical relaxation to help reduce stress and tension, which can improve sleep quality. Both methods are promising as they aim to address insomnia through behavioral changes rather than pharmacological interventions, appealing to those who prefer or require drug-free options.

What evidence suggests that this trial's treatments could be effective for insomnia in PTSD?

Research has shown that Brief Behavioral Treatment for Insomnia (BBTI), which participants in this trial may receive, helps veterans sleep better and reduces trauma-related nightmares. Veterans who tried BBTI not only experienced better sleep but also maintained these improvements over time. BBTI also enhanced their social interactions and mood. In contrast, Progressive Muscle Relaxation Training (PMRT), another treatment option in this trial, helped individuals relax more and improve sleep quality. PMRT also reduced symptoms like depression and anxiety in those with post-traumatic stress. Both treatments have demonstrated positive results, but BBTI appears more effective for sleep issues in veterans. ^{1 2 6 7 8}

Who Is on the Research Team?

Shira Maguen, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a military veteran aged between 18 and 75.

Veterans who meet DSM-5 Criteria for Insomnia Disorder

I have been in psychotherapy for over a month and won't stop during the trial.

Exclusion Criteria

Veterans with unstable housing

Veterans who work night or rotating shifts

Veterans who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Brief Behavioral Treatment for Insomnia (BBTI) or Progressive Muscle Relaxation Training (PMRT) over 4 sessions

4 weeks

4 sessions (video and phone-based)

Follow-up

Participants are monitored for psychosocial functioning and insomnia severity, with additional follow-up for the BBTI group

6 months

Follow-up assessments at 6 months for BBTI group

What Are the Treatments Tested in This Trial?

Interventions

• Brief Behavioral Treatment for Insomnia (BBTI)
• Progressive Muscle Relaxation Training (PMRT)

Trial Overview 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.

How Is the Trial Designed?

Group I: BBTI Experimental Treatment 1 Intervention

Participants in this arm will receive 4 sessions (30-60 minutes) of a brief behavioral treatment for insomnia (BBTI). Relaxation techniques are not a component of BBTI.

Group II: PMRT Active Control 1 Intervention

Participants in this arm will receive 4 sessions (30-60 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)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A study involving 91 veterans with insomnia found that brief behavioral treatment for insomnia (BBTI) led to significant improvements in psychosocial functioning, insomnia symptoms, and mood compared to a control group receiving progressive muscle relaxation training (PMRT).

The benefits of BBTI were not only immediate but also sustained for at least 6 months after treatment, indicating its effectiveness as a long-term solution for insomnia in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. Maguen, S., Gloria, R., Huggins, J., et al.[2021]

Prolonged exposure (PE) therapy alone did not significantly improve sleep quality in veterans with PTSD, despite reducing PTSD symptoms as measured by standard scales.

Adding sleep interventions like imagery rehearsal therapy (IRT) and cognitive-behavioral therapy for insomnia (CBT-I) to PE resulted in significant improvements in insomnia symptoms and a trend towards reduced nightmare frequency, suggesting that integrating sleep treatments can enhance overall PTSD therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of prolonged exposure on sleep and enhancing treatment outcomes with evidence-based sleep interventions: A pilot study. Walters, EM., Jenkins, MM., Nappi, CM., et al.[2021]

Brief behavioral treatment for insomnia (BBTI) was found to be effective in improving sleep quality and reducing insomnia symptoms in 79 adults with treatment-resistant insomnia, showing significant improvements in various sleep measures compared to sleep hygiene education.

The study demonstrated moderate to large effect sizes for BBTI, indicating it is a simple and effective intervention for chronic insomnia, with improvements noted in sleep latency, efficiency, and overall sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for patients with treatment-resistant insomnia. Wang, J., Wei, Q., Wu, X., et al.[2020]

The Brief Behavioral Treatment for Insomnia (BBTI) was effective in helping veterans with insomnia develop skills for independent improvement, as reported by 46 veterans who participated in qualitative interviews after treatment.

Veterans appreciated the initial in-person sessions and the accountability provided by BBTI, but suggested improvements such as better personalization and clearer expectations for phone sessions to enhance the treatment experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Barriers to Behavioral Treatments for Insomnia: A Qualitative Examination of Veterans' Perspectives of BBTI. Holder, N., Kanady, JC., Straus, LD., et al.[2022]

A brief behavioral treatment for insomnia (BBTI) was tested against cognitive behavioral therapy for insomnia (CBTI) in a study involving 63 veterans, showing that both treatments significantly reduced insomnia severity, but BBTI's effectiveness was inconclusive compared to CBTI.

While CBTI showed a greater reduction in insomnia severity, the difference was not statistically significant enough to declare BBTI inferior, suggesting that BBTI could be a viable alternative for veterans seeking shorter treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. Bramoweth, AD., Lederer, LG., Youk, AO., et al.[2023]

Brief Behavioral Treatment for Insomnia (BBTI) is a concise, four-session therapy designed to overcome barriers to accessing traditional cognitive-behavioral therapy for insomnia (CBTI), making it easier for clinicians to deliver.

BBTI has shown efficacy in treating older adults with insomnia, providing a practical alternative to standard CBTI, which is limited by a shortage of trained clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of insomnia with brief behavioral treatment (BBTI). Troxel, WM., Germain, A., Buysse, DJ.[2022]

A survey of 154 military sleep health care providers revealed that while 68% reported availability of cognitive-behavioral treatment for insomnia (CBTI/BBTI), less than 50% of patients diagnosed with insomnia actually receive these treatments, indicating a significant gap in care.

Key barriers to implementing CBTI/BBTI include under-resourced clinics and scheduling limitations, while facilitators include having trained providers and leadership support, suggesting that improving resources and workflows could enhance insomnia treatment for service members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. Germain, A., Wolfson, M., Klenczar, B., et al.[2023]

The study involving 91 military veterans found that Brief Behavioral Treatment for Insomnia (BBTI) significantly reduced trauma-related nightmares compared to an active control group using progressive muscle relaxation therapy, although these reductions were not maintained at a 6-month follow-up.

Neither BBTI nor progressive muscle relaxation therapy had an effect on nontrauma-related bad dreams, indicating that while BBTI may help with trauma-related nightmares, its impact on other types of bad dreams remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. Ranney, RM., Gloria, R., Metzler, TJ., et al.[2023]

Citations

1. academic.oup.com academic.oup.com/sleep/article/44/3/zsaa205/5918478

Brief behavioral treatment for insomnia improves psychosocial ... Veterans who received BBTI improved and maintained gains in psychosocial functioning, insomnia, and mood.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9243281/

Brief behavioral treatment for insomnia decreases trauma ... We found that BBTI significantly reduced trauma-related nightmares from baseline to posttreatment, whereas progressive muscle relaxation therapy did not.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02571452

NCT02571452 | Brief Behavioral Insomnia Treatment Study The purpose of this study is to determine whether a brief, behavioral treatment for insomnia is effective in addressing social and occupational functioning and ...

4. reporter.nih.gov reporter.nih.gov/search/FKYEH9S8IUyyf4fkTRSwdA/project-details/11191405

Brief Behavioral Treatment for Insomnia in Veterans with ... The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include assessing ...

5. withpower.com withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-4-2023-ac73f

Behavioral Treatment for Insomnia in PTSD Research shows that Brief Behavioral Treatment for Insomnia (BBTI) is effective in improving sleep and reducing trauma-related nightmares in veterans, similar ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05780177

Brief Behavioral Treatment for Insomnia in Veterans With ... This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07167706

Study Details | NCT07167706 | Sleep Difficulties After Loss ... The study is a randomized controlled trial comparing the effect of a brief behavioral therapy for insomnia (BBTI) on insomnia with an active ...

8. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id42060.pdf

Cognitive Behavioral Therapy for Insomnia in Posttraumatic ... Conclusions: Cognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo.