Clinical trial NCT05935735: Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery
Official title: Using Implementation Science to Examine the Feasibility and Efficacy of Brief Behavioral Therapy for Insomnia (BBTI) in Substance Use Disorder Recovery Programs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Insomnia
Keywords: Brief Behavioral Therapy for Insomnia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2023-07-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Outreach
timeFrame: Up to 1 year
measure: Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Adoption
timeFrame: Up to 1 year
measure: Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Treatment Integrity
timeFrame: Up to 1 year
measure: Changes in the Symptoms of Insomnia after Brief Behavioral Therapy for Insomnia (BBTI) as Measured by Insomnia Severity Index (ISI)
timeFrame: Baseline and post intervention up to 4 weeks
measure: Changes in Sleep Efficiency after Brief Behavioral Therapy for Insomnia (BBTI) as Measured by Actigraphy
timeFrame: Baseline and post intervention up to 4 weeks
measure: Changes in Substance Used Outcome as Measured by Treatment Retention [days]
timeFrame: Baseline and post intervention up to 4 weeks
Secondary outcomes:
measure: Treatment Satisfaction Rate as Assessed by Treatment Satisfaction Survey
timeFrame: 5 Weeks
measure: Treatment Adherence Rate as Assessed by Treatment Adherence
timeFrame: 5 Weeks
measure: Maintenance of Intervention
timeFrame: Up to 1 year
measure: Post-treatment Substance Use Disorder Relapse Rate as Assessed by Treatment Retention [days]
timeFrame: Up to 4 weeks post intervention
measure: Change in Quality of life as Measured by PROMIS Global Health Scale
timeFrame: Baseline and post intervention up to 4 weeks
measure: Change in Depression Measured by PROMIS Depression Scale
timeFrame: Baseline and post intervention up to 4 weeks
measure: Change in Anxiety Measured by PROMIS Anxiety Scale
timeFrame: Baseline and post intervention up to 4 weeks
measure: Change in Pain Measured by PROMIS Pain Interference Scale
timeFrame: Baseline and post intervention up to 4 weeks
measure: Change in Pain Measured by PROMIS Pain Severity Scale
timeFrame: Baseline and post intervention up to 4 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Cornerstone at Helping Up Mission Clinic
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Traci J Speed, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: