Testing a brief therapy for insomnia in people recovering from substance use disorders
Using Implementation Science to Examine the Feasibility and Efficacy of Brief Behavioral Therapy for Insomnia (BBTI) in Substance Use Disorder Recovery Programs
This study is testing a short therapy for insomnia to see if it can help people recovering from substance use disorders get better sleep while they are in treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05935735 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the feasibility and efficacy of Brief Behavioral Therapy for Insomnia (BBTI) in individuals with substance use disorders (SUD) residing in a treatment program. Participants will engage in a 4-week intervention that includes completing surveys, wearing a sleep-monitoring device, and maintaining a sleep diary. The study will assess both subjective and objective sleep outcomes while utilizing the RE-AIM framework to inform the implementation of this therapy in real-world settings. The ultimate goal is to provide evidence supporting the integration of BBTI into SUD recovery programs to enhance treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with active substance use disorders and insomnia, residing at the Helping Up Mission.
Not a fit: Patients with severe medical or psychiatric conditions, those unable to provide informed consent, or individuals with certain sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sleep quality and recovery outcomes for patients with substance use disorders.
How similar studies have performed: Other studies have shown success with behavioral therapies for insomnia, but this specific application in SUD recovery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Cornerstone at Helping Up Mission Clinic — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Traci J Speed, MD/PHD — Johns Hopkins University
- Study coordinator: Traci J Speed, MD/PHD
- Email: speed@jhmi.edu
- Phone: 410-550-7985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.