Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery

NCT ID: NCT05935735

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

Brief behavioral treatment for insomnia (BBTI) is an efficacious evidence-based sleep intervention derived from cognitive behavioral therapy for insomnia (CBT-I) that may address barriers to widespread dissemination of insomnia therapy because it is brief (4 weeks), easily deliverable without need for specialty training (uses a hard-copy workbook) and behaviorally-focused. This proposal has the following two aims:

1. To use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, a well-established implementation framework that informs evaluation of health-related programs, including in community and substance use treatment settings, to evaluate the feasibility of implementing a modified BBTI among underserved special population of individuals in a residential recovery program;

2. To conduct a clinical trial to evaluate the efficacy of the modified BBTI on subjective and objective sleep outcomes compared with conventional standard-of-care. The end goal of this project is to provide empirical evidence of a modified BBTI's value in SUD recovery for individuals of diverse racial backgrounds. Successful completion of this study will promote the dissemination and sustainable adoption of an evidence-based, pragmatic, and accessible insomnia intervention in real-world SUD recovery programs.

Conditions

Substance Use Disorders; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BBTI Group

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 Type: EXPERIMENTAL

Brief Behavioral Therapy for Insomnia (BBTI)

Intervention Type: BEHAVIORAL

4 in-person sessions; 1 individual and 3 group sessions

SOC Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief Behavioral Therapy for Insomnia (BBTI)

4 in-person sessions; 1 individual and 3 group sessions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• client of Cornerstone Clinic (CC); resident at Helping Up Mission (HUM)
• active SUD
• ≥ 18 years old
• ISI ≥ 8
• insomnia disorder as determined by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Sleep Disorders (SIS-D)
• able to understand English proficiently

Exclusion Criteria

• medical or psychiatric condition interfering with treatment or requiring hospitalization
• inability to provide informed consent
• declines behavioral health treatment at CC
• suicidal ideation
• acute alcohol withdrawal requiring medical attention
• pregnant or breastfeeding
• moderate-severe sleep apnea based on WatchPAT
• restless legs syndrome based on SIS-D
• discharged from HUM

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Academy of Sleep Medicine

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Traci J Speed, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Cornerstone at Helping Up Mission Clinic

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Traci J Speed, MD/PHD

Role: CONTACT

speed@jhmi.edu

410-550-7985

Denis Antoine, MD

Role: CONTACT

antoine@jhmi.edu

410-550-2796

Facility Contacts

Denis Antoine, MD

Role: primary

antoine@jhmi.edu

410-550-2796 ext. 112

Other Identifiers

IRB00343251

Identifier Type: -

Identifier Source: org_study_id