RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Using Implementation Science to Examine the Feasibility and Efficacy of Brief Behavioral Therapy for Insomnia (BBTI) in Substance Use Disorder Recovery Programs

Quick Facts

Study Start:2023-07-26
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05935735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * client of Cornerstone Clinic (CC); resident at Helping Up Mission (HUM)
  2. * active SUD
  3. * ≥ 18 years old
  4. * ISI ≥ 8
  5. * insomnia disorder as determined by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Sleep Disorders (SIS-D)
  6. * able to understand English proficiently
  1. * medical or psychiatric condition interfering with treatment or requiring hospitalization
  2. * inability to provide informed consent
  3. * declines behavioral health treatment at CC
  4. * suicidal ideation
  5. * acute alcohol withdrawal requiring medical attention
  6. * pregnant or breastfeeding
  7. * moderate-severe sleep apnea based on WatchPAT
  8. * restless legs syndrome based on SIS-D
  9. * discharged from HUM

Contacts and Locations

Study Contact

Traci J Speed, MD/PHD
CONTACT
410-550-7985
speed@jhmi.edu
Denis Antoine, MD
CONTACT
410-550-2796
antoine@jhmi.edu

Principal Investigator

Traci J Speed, MD/PHD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Cornerstone at Helping Up Mission Clinic
Baltimore, Maryland, 21203
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Traci J Speed, MD/PHD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-26
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-07-26
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Brief Behavioral Therapy for Insomnia

Additional Relevant MeSH Terms

  • Substance Use Disorders
  • Insomnia