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

Completed · Not applicable

Conditions studied: Substance Use Disorders, Insomnia

In brief

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.

Key facts

Study ID

NCT05935735

Run by

Johns Hopkins University

People needed

83

Starts

2023-07-26

Expected to finish

2026-04-02

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cornerstone at Helping Up Mission Clinic — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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