Brief Behavioral Therapy for Insomnia in Substance Use Recovery

(BBTI_SUDs Trial)

Overseen By Denis Antoine, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Hospitalization, Suicidal ideation, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical study is to learn whether treating sleep problems is helpful in people with substance abuse problems who are living in a residential treatment program. Another goal is to study whether treating sleep problems will help individuals stay in substance abuse recovery treatment for a greater amount of time. Participants will be asked to complete surveys at the time of enrollment and every week for the next 9 weeks for a total of 8 times. Participants will be asked to wear a watch that measures sleep (sleep watch) while the participants are in the group and for a 2-week period after the participants complete the group. Participants may also be asked to participate in an interview about the experience with the group and wearing the watch. Participants will also have "homework" throughout a 4 week period. Homework is to complete a sleep diary each morning. The first group of 50 participants will be enrolled in the brief behavioral treatment for insomnia (BBTI) group where the participants receive typical treatment plus the sleep intervention program. The investigators will use qualitative and quantitative data to identify implementation facilitators and barriers, then further modify BBTI to improve feasibility. After modifying the BBTI protocol and re-training staff, study procedures will remain intact with the exception that the investigators will double the recruitment and randomize participants to the modified BBTI (N=50) or standard-of-care (SOC) (N=50). All participants will complete all assessments except the SOC group will not complete treatment satisfaction surveys.

Do I need to stop my current medications for this trial?

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 healthcare provider.

What data supports the effectiveness of the treatment Brief Behavioral Therapy for Insomnia (BBTI) in substance use recovery?

Research shows that Brief Behavioral Treatment for Insomnia (BBTI) is effective in reducing insomnia symptoms like difficulty falling asleep and staying asleep, and it can even lead to full recovery from insomnia. It has been successfully used in various groups, including older adults with depression and lung cancer survivors, improving both sleep and quality of life. ^{1 2 3 4 5}

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

The available research on Brief Behavioral Therapy for Insomnia (BBTI) does not report any specific safety concerns, suggesting it is generally safe for humans. It has been used successfully in various groups, including veterans and older adults, without noted adverse effects. ^{1 2 3 4 6}

How is Brief Behavioral Therapy for Insomnia (BBTI) different from other treatments for insomnia?

BBTI is unique because it is a short, four-session treatment that can be delivered by non-psychologist health professionals, making it more accessible than traditional cognitive behavioral therapy for insomnia (CBTI). It focuses on practical strategies to improve sleep and can be administered in various settings, including over the phone, which helps overcome common barriers to treatment. ^{1 2 3 4 5}

Research Team

Traci J Speed, MD/PHD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 with substance use disorders and insomnia, receiving care at specific clinics. They must have an Insomnia Severity Index score of 8+ and a diagnosis of insomnia. Excluded are those with severe medical/psychiatric issues, acute alcohol withdrawal, pregnant/breastfeeding women, or certain sleep conditions like severe apnea.

Inclusion Criteria

Active substance use disorder (SUD)

Client of Cornerstone Clinic (CC) or resident at Helping Up Mission (HUM)

I am 18 years old or older.

Exclusion Criteria

Acute alcohol withdrawal requiring medical attention

I have been diagnosed with restless legs syndrome.

I do not have any health or mental conditions that would interfere with treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brief Behavioral Therapy for Insomnia (BBTI) over 4 weeks, including 4 in-person sessions and completing sleep diaries.

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in sleep efficiency and other outcomes, wearing a sleep watch for 2 weeks post-treatment.

4 weeks

Weekly surveys for 9 weeks, 2 weeks of sleep watch monitoring

Maintenance

Maintenance of intervention is assessed over one year to evaluate long-term feasibility and adoption.

Up to 1 year

Treatment Details

Interventions

• Brief Behavioral Therapy for Insomnia (BBTI)

Trial Overview The study tests if Brief Behavioral Therapy for Insomnia (BBTI) helps people in substance abuse recovery stay in treatment longer. Participants will complete surveys, wear a sleep watch, keep a sleep diary as homework, and may be interviewed about their experience.

Participant Groups

Group I: BBTI Group Experimental Treatment 1 Intervention

Participants will receive 4 in-person sessions of Brief Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery

Group II: SOC Group Active Control 1 Intervention

Participants will receive their usual substance abuse treatment as part of their intensive outpatient treatment of substance use recovery

Brief Behavioral Therapy for Insomnia (BBTI) is already approved in United States, European Union for the following indications:

Approved in United States as Brief Behavioral Therapy for Insomnia for:

• Insomnia
• Substance Use Disorder recovery support

Approved in European Union as Brief Behavioral Therapy for Insomnia for:

• Insomnia
• Comorbid psychiatric, medical, or sleep disorders

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Findings from Research

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 feasible for older Veterans with late-life treatment resistant depression (LLTRD) and insomnia, with a high retention rate of 90.9% and positive feedback from all participants.

BBTI showed significant improvements in both insomnia and depression symptoms after treatment, indicating its potential as an effective adjunctive therapy for depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for insomnia in older adults with late-life treatment-resistant depression and insomnia: a pilot study. Gebara, MA., DiNapoli, EA., Lederer, LG., et al.[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]

The Brief Behavioral Treatment for Insomnia (BBTI) significantly improved sleep efficiency in lung cancer survivors, with over 85% of participants showing improvement, compared to no change in the Healthy Eating Program (HEP) control group.

BBTI also enhanced the quality of life, as indicated by a significant increase in the FACT-L score, while the HEP group experienced a decline, highlighting BBTI's potential as an effective intervention for insomnia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. Dean, GE., Weiss, C., Jungquist, CR., et al.[2021]

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]

References

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

Brief Behavioral Treatment of Insomnia. [2019]

2. 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]

3. Japan pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for insomnia in older adults with late-life treatment-resistant depression and insomnia: a pilot study. [2022]

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

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

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

Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. [2021]

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

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