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NCT05935735 · ClinicalTrials.gov registry record · NA
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery
A NA study of Insomnia and Substance Use Disorders, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05935735: Recruiting NA study of Insomnia and Substance Use Disorders, sponsored by Johns Hopkins University.
NCT05935735 is a NA study of Insomnia and Substance Use Disorders that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 150 participants, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (11% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05935735, a NA study of Insomnia and Substance Use Disorders, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Brief Behavioral Therapy for Insomnia (BBTI)
Study Locations (1)
Maryland
- Cornerstone at Helping Up Mission Clinic - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-07-26 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT05935735 shows while recruiting
NCT05935735 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 169-participant average among 151 other Insomnia trials with a reported enrollment target (11% lower).
The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Brief Behavioral Therapy for Insomnia (BBTI) is the first listed.
NCT05935735 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05935735 about?
NCT05935735 is a clinical study titled "Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery". 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 ...
What is the current status of trial NCT05935735?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2023-07-26. Estimated completion is 2026-12.
What conditions does trial NCT05935735 study?
This clinical trial studies the following conditions: Insomnia, Substance Use Disorders.
What interventions are being tested in trial NCT05935735?
The interventions under investigation include: Brief Behavioral Therapy for Insomnia (BBTI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05935735?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05935735 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05935735's enrollment target sits among peer trials
150 49th of 151 higher than 102 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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