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

NCT05935735 | Completed

• 1 other identifier: IRB00343251
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Substance Use Disorders

Keywords

Brief Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcomes (6)

• Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Outreach

  The success rate of outreach is measured by: * Percent of eligible Helping Up Mission (HUM) residents who were referred to study * Percent of eligible HUM residents who consented to study * Percent of HUM residents who attended BBTI Session 1 If overall score from the three parameters above is greater than 50%, outreach is feasible

  Up to 1 year

• Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Adoption

  The success rate of adoption is measured by: * Provider satisfaction with training as assessed by semi-structured interviews with Cornerstone Clinic researchers and staff, HUM leadership, and providers * Provider satisfaction with facilitating BBTI as assessed by semi-structured interviews with participants If overall score from the parameters above is greater than 80%, adoption is feasible

  Up to 1 year

• Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) as Assessed by the Success Rate of Treatment Integrity

  The success rate of treatment integrity is measured by percent of maintaining treatment based on fidelity checklist. If overall score is above 85% treatment integrity is feasible

  Up to 1 year

• Changes in the Symptoms of Insomnia after Brief Behavioral Therapy for Insomnia (BBTI) as Measured by Insomnia Severity Index (ISI)

  Participants will complete ISI. Investigators will compare pre- and post-intervention primary outcomes. ISI is a 7-item questionnaire assessing the nature and symptoms of insomnia. ISI total score is the sum of all item scores which ranges from 0-28 and is interpreted as follows: no clinically significant insomnia (0-7), subthreshold insomnia (8-14), moderate clinical insomnia (15-21), and severe clinical insomnia (22-28). Negative changes in scores indicate improvement.

  Baseline and post intervention up to 4 weeks

• Changes in Sleep Efficiency after Brief Behavioral Therapy for Insomnia (BBTI) as Measured by Actigraphy

  Participants in both arms will complete daily sleep diaries and wear an actiwatch. Sleep Efficiency is a measure of total sleep time over time in bed. Higher sleep efficiency indicates improved sleep.

  Baseline and post intervention up to 4 weeks

• Changes in Substance Used Outcome as Measured by Treatment Retention [days]

  Treatment retention is number of days in substance used treatment. Treatment retention days will be counted by the number of days that the client is in treatment at the Helping Up Mission.

  Baseline and post intervention up to 4 weeks

Secondary Outcomes (9)

• Treatment Satisfaction Rate as Assessed by Treatment Satisfaction Survey

  5 Weeks

• Treatment Adherence Rate as Assessed by Treatment Adherence

  5 Weeks

• Maintenance of Intervention

  Up to 1 year

• Post-treatment Substance Use Disorder Relapse Rate as Assessed by Treatment Retention [days]

  Up to 4 weeks post intervention

• Change in Quality of life as Measured by PROMIS Global Health Scale

  Baseline and post intervention up to 4 weeks

Study Arms (2)

BBTI Group

EXPERIMENTAL

Participants will receive 4 in-person sessions of Brief Behavioral Therapy for insomnia as part of their intensive outpatient treatment of substance use recovery

Behavioral: Brief Behavioral Therapy for Insomnia (BBTI)

SOC Group

NO INTERVENTION

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

Interventions

Brief Behavioral Therapy for Insomnia (BBTI) BEHAVIORAL

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

BBTI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Cornerstone at Helping Up Mission Clinic

Baltimore, Maryland, 21203, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Traci J Speed, MD/PHD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: July 26, 2023
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)