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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if treating sleep problems can help individuals in substance abuse recovery programs remain in treatment longer. It tests a sleep-focused therapy called Brief Behavioral Therapy for Insomnia (BBTI) alongside standard care, compared to standard care alone. Individuals diagnosed with insomnia and actively dealing with substance use issues might be suitable candidates. Participants will wear a sleep-tracking watch, complete surveys, and maintain a sleep diary to help researchers assess the treatment's impact. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery outcomes for many.

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 prior data suggests that this behavioral therapy is safe for individuals in substance use recovery?

Research has shown that Brief Behavioral Therapy for Insomnia (BBTI) is a well-accepted treatment for sleep problems, even for individuals with substance use disorders. Studies have found that BBTI improves sleep by changing sleep habits and practicing relaxation techniques.

Participants often report that BBTI is safe and doesn't cause serious side effects, which is crucial for those considering a clinical trial. Since the treatment doesn't involve medication, it typically results in fewer negative side effects.

Past research has demonstrated that BBTI is safe for various groups, including those with other mental health issues. This suggests it’s a gentle way to improve sleep without causing extra stress. For those considering a trial that includes BBTI, these findings indicate it's a promising and safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brief Behavioral Therapy for Insomnia (BBTI) because it offers a fresh approach to tackling insomnia in individuals recovering from substance use. Unlike standard treatments that often rely on medication, BBTI focuses on behavioral techniques, providing four in-person sessions that equip participants with practical strategies to improve their sleep patterns. This method is particularly promising because it avoids potential interactions with substances and can empower individuals with skills that support long-term recovery and sleep improvement.

What evidence suggests that Brief Behavioral Therapy for Insomnia might be an effective treatment for sleep problems in substance use recovery?

Research has shown that Brief Behavioral Therapy for Insomnia (BBTI) can improve sleep problems. Studies have found BBTI effective in reducing insomnia symptoms in cannabis users and potentially beneficial for those with other substance use issues. Participants in these studies often reported better sleep and fewer substance use problems after BBTI. In this trial, participants in the BBTI Group will receive structured sessions focused on improving sleep habits and behaviors, making it a potentially helpful tool for managing insomnia during substance use recovery. This suggests BBTI might help individuals remain in recovery programs longer by addressing their sleep issues. ^{3 6 7 8 9}

Who Is on the Research Team?

Traci J Speed, MD/PHD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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)

Insomnia Severity Index (ISI) score ≥ 8

Exclusion Criteria

Acute alcohol withdrawal requiring medical attention

I have been diagnosed with restless legs syndrome.

Moderate-severe sleep apnea based on WatchPAT

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8664982/

A pilot randomized clinical trial of brief behavioral treatment ...

This pilot study suggests BBTI may be efficacious not only in improving insomnia symptoms among cannabis users but also in reducing cannabis-related problems ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0740547221002634

A pilot randomized clinical trial of Brief Behavioral ...

This pilot study suggests BBTI may be efficacious not only in improving insomnia symptoms among cannabis users but also in reducing cannabis-related problems ...

3.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT07167706

Study Details | NCT07167706 | Sleep Difficulties After Loss ...

The goal of the study is to investigate whether a brief behavioral therapy for insomnia (BBTI) improves sleep in bereaved patients screened ...

4.

trial.medpath.com

trial.medpath.com/clinical-trial/95e0b505019737f4/implementation-science-brief-behavioral-therapy-insomnia

Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in ...

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 ...

5.

withpower.com

withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-6-2023-31e8a

Brief Behavioral Therapy for Insomnia in Substance Use ...

The BBTI_SUDs medical study, being run by Johns Hopkins University, is evaluating whether Brief Behavioral Therapy for Insomnia (BBTI) will have tolerable ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02248675

Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) ...

Veterans with common chronic conditions such as PTSD, depression, substance abuse and chronic pain are at increased risk for suicide. Although evidence-based ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31029189/

Brief Behavioral Treatment of Insomnia

Cognitive behavioral treatment for insomnia (CBTI) is an effective treatment of insomnia; however, there are insufficient CBTI providers for ...

8.

aasm.org

aasm.org/wp-content/uploads/2022/07/ProviderFS-BBTI.pdf

Brief Behavioral Treatment for Insomnia (BBTI)

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a type of psychological treatment that utilizes stimulus control, sleep restriction, relaxation training ...

9.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/2806248

Effect of Cognitive Behavioral Therapy for Insomnia on ...

Eligible participants (1) were enrolled in addiction treatment, (2) reported alcohol use in the past 2 months at baseline, (3) met DSM-5 ...