Behavioral Treatments for Insomnia

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

Disqualifiers: Depression, Bipolar, Psychosis, Substance abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall objective of this study is to conduct a randomized effectiveness-implementation trial to test the non-inferiority of tele-Brief Behavioral Treatment for Insomnia vs. tele-Cognitive-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults with insomnia in the primary care setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Tele-Cognitive-Behavioral Therapy for Insomnia (Tele-CBT-I)?

Research shows that Tele-CBT-I is effective in treating insomnia, with studies indicating it works as well as face-to-face therapy. It helps reduce symptoms like difficulty falling asleep and staying asleep, and improves overall sleep quality. ^{1 2 3 4 5}

Is behavioral treatment for insomnia safe for humans?

Behavioral treatments for insomnia, like Cognitive Behavioral Therapy for Insomnia (CBT-I) and its brief versions such as BBTI, are generally considered safe for humans. These treatments focus on changing sleep habits and behaviors without the use of medication, and there is no evidence suggesting they pose significant safety risks. ^{1 2 3 4 5}

How is the Tele-Brief Behavioral Treatment for Insomnia different from other treatments for insomnia?

Tele-Brief Behavioral Treatment for Insomnia (Tele-BBTI) is unique because it offers a shorter, more accessible version of traditional cognitive-behavioral therapy for insomnia (CBT-I), with only four sessions that can be conducted via telemedicine. This makes it easier for people who have limited access to specialized therapists, as it can be delivered by non-specialist health professionals and includes both in-person and phone sessions. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for socioeconomically disadvantaged adults who have insomnia, with a severity score over 11. It's open to those eligible for public medical assistance or identifying as a racial/ethnic minority or Spanish-speaking.

Inclusion Criteria

Insomnia severity score > 10

Eligible to receive care through publicly supported medical assistance

Identify as race or ethnic minority

Exclusion Criteria

Regular nightshift work

I have major depression that hasn't been treated yet.

Severe medical condition, which may require hospitalizations over the next 6 months

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tele-Brief Behavioral Treatment for Insomnia or tele-Cognitive-Behavioral Therapy for Insomnia

12 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Tele-Brief Behavioral Treatment for Insomnia (Behavioral Intervention)
• Tele-Cognitive-Behavioral Therapy for Insomnia (Behavioral Intervention)

Trial Overview The study compares two remote treatments for insomnia in primary care: tele-Brief Behavioral Treatment and tele-Cognitive-Behavioral Therapy, to see if one is not worse than the other.

Participant Groups

Group I: Tele-Brief Behavioral Treatment for Insomnia Experimental Treatment 1 Intervention

Group II: Tele-Cognitive-Behavioral Therapy for Insomnia Active Control 1 Intervention

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Findings from Research

Cognitive behavioral therapy for insomnia (CBT-i) is the recommended first-line treatment for insomnia, and telemedicine options for CBT-i enhance access for patients, especially those in remote areas.

Research, including multiple studies and meta-analyses, shows that tele-CBT-i is effective, performing comparably to traditional face-to-face CBT-i and better than placebo treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine and the Management of Insomnia. Hsieh, C., Rezayat, T., Zeidler, MR.[2020]

Brief behavioral treatment for insomnia (BBTI) is a 4-session program that can effectively reduce insomnia symptoms, such as difficulty falling asleep and waking up during the night, making it a practical option for non-psychologist health professionals to administer.

BBTI has shown promising results, including cases of full remission from insomnia, and ongoing clinical trials are exploring its efficacy in different treatment settings and delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. Gunn, HE., Tutek, J., Buysse, DJ.[2019]

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]

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]

References

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

Telemedicine and the Management of Insomnia. [2020]

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

Brief Behavioral Treatment of Insomnia. [2019]

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

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

5. England pubmed.ncbi.nlm.nih.gov

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