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

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.

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.

What data supports the effectiveness of the 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 to longer cognitive-behavioral therapy. It also enhances psychosocial functioning and is recommended as a first-line treatment for insomnia in military settings. ^{1 2 3 4 5}

Is Brief Behavioral Treatment for Insomnia (BBTI) safe for humans?

BBTI is generally considered safe for humans, as it is a non-drug treatment focusing on behavioral changes to improve sleep. It has been used successfully in various populations, including veterans, without significant safety concerns reported. ^{2 4 5 6 7}

How is the treatment for insomnia in PTSD different from other treatments?

The Brief Behavioral Treatment for Insomnia (BBTI) is unique because it requires fewer sessions (only 4) compared to traditional cognitive-behavioral therapy for insomnia (CBT-I), making it a quicker option for treating insomnia. It also specifically targets trauma-related nightmares, which are common in PTSD, and has been shown to improve psychosocial functioning in veterans. ^{1 3 4 5 8}

Research Team

Shira Maguen, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for insomnia decreases trauma-related nightmare frequency in veterans. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Clinical management of insomnia with brief behavioral treatment (BBTI). [2022]

3. England 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for insomnia improves psychosocial functioning in veterans: results from a randomized controlled trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Reducing Barriers to Behavioral Treatments for Insomnia: A Qualitative Examination of Veterans' Perspectives of BBTI. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for patients with treatment-resistant insomnia. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The impact of prolonged exposure on sleep and enhancing treatment outcomes with evidence-based sleep interventions: A pilot study. [2021]