Behavioral Treatments for Insomnia

Overseen By Suzanne Bertisch, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different online treatments for insomnia to determine their effectiveness for adults struggling with sleep. It focuses on individuals with insomnia who cannot afford private healthcare or belong to racial or ethnic minority groups. Participants will be randomly assigned to either tele-Brief Behavioral Treatment for Insomnia or tele-Cognitive-Behavioral Therapy for Insomnia. Both treatments aim to improve sleep habits and reduce insomnia symptoms. Suitable candidates for this trial are adults diagnosed with insomnia who find it difficult to achieve restful sleep. As an unphased trial, this study offers a unique opportunity to access innovative treatments that may enhance sleep quality.

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.

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

Research shows that both Tele-Brief Behavioral Treatment for Insomnia (BBTI) and Tele-Cognitive-Behavioral Therapy for Insomnia (CBT-I) are safe for people.

Studies have found that BBTI improves sleep without causing serious side effects. People report better sleep and fewer insomnia symptoms after this treatment.

Research indicates that CBT-I is also safe and easy to manage. It is often recommended as the first choice for treating insomnia, with fewer side effects compared to other insomnia treatments.

Both treatments work by changing behaviors and thoughts related to sleep, without using medication, which often means fewer risks of side effects.

In short, these therapies improve sleep and are safe options for treating insomnia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for insomnia because they harness the power of telemedicine to deliver behavioral therapies directly to patients at home. Unlike traditional in-person cognitive-behavioral therapy or medication, the Tele-Brief Behavioral Treatment for Insomnia provides a concise and accessible approach that may be more convenient for those with busy schedules. Similarly, Tele-Cognitive-Behavioral Therapy for Insomnia offers a full therapy experience remotely, potentially increasing access for those who may have difficulty attending regular therapy sessions. Both approaches could make effective insomnia treatment more widely available, without the need for medication.

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

This trial will compare two treatments for insomnia: Tele-Brief Behavioral Treatment for Insomnia (Tele-BBTI) and Tele-Cognitive-Behavioral Therapy for Insomnia (Tele-CBTI). Research has shown that both effectively treat insomnia. Studies have found that Tele-BBTI can greatly reduce insomnia severity, with noticeable sleep improvements within just a few weeks. Specifically, older adults with long-term insomnia experienced significant sleep improvements after only four weeks of Tele-BBTI. Meanwhile, Tele-CBTI has proven as effective as sleep medication, offering lasting benefits with fewer chances of insomnia returning. It can enhance sleep quality and lessen insomnia severity, making it a recommended first choice for treating chronic insomnia. Both treatments offer promising options for effectively managing insomnia. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tele-Brief Behavioral Treatment for Insomnia
• Tele-Cognitive-Behavioral Therapy for Insomnia

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.

How Is the Trial Designed?

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

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

Tele-Brief Behavioral Treatment for Insomnia is already approved in United States for the following indications:

Approved in United States as Tele-BBTI for:

• Chronic Insomnia Disorder

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8994790/

Brief Behavioral Treatment for Insomnia: A Meta-Analysis Overall, the present meta-analysis demonstrated that BBTI is an effective treatment for insomnia at early follow-up, as it produced meaningful improvements on ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/227356

Efficacy of Brief Behavioral Treatment for Chronic Insomnia ... Older adults with chronic insomnia treated with BBTI showed clinically and statistically significant improvement in sleep outcomes at 4 weeks ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442200386X

Provider-supported self-management cognitive behavioral ... We hypothesize that, relative to a health education control condition, participants randomized to Tele-Self CBTi will have greater improvements in insomnia ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/15402002.2022.2082429

Adapting Brief Behavioral Treatment for Insomnia ... In exploratory analyses, we observed improvements in sleep disturbance, sleep-related impairment scores, and diary-reported SE and TST. More ...

5. sigmapubs.onlinelibrary.wiley.com sigmapubs.onlinelibrary.wiley.com/doi/10.1111/wvn.70075?af=R

Comparative Efficacy of Brief Behavioral Therapy for Insomnia ... Compared with usual care, BBTI significantly reduced insomnia severity (mean difference [MD] = −4.79; 95% confidence interval [CI = −6.05, −3.53]; ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4977084/

Brief behavioral treatment for patients with treatment-resistant ... To evaluate the efficacy of brief behavioral treatment for insomnia (BBTI) in treating patients with treatment-resistant insomnia.

7. 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 ...