← Back to Search

Behavioural Intervention

Brief Behavioral Therapy for Insomnia in Substance Use Recovery (BBTI_SUDs Trial)

N/A

Recruiting

Led By Traci J Speed, MD/PHD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

BBTI_SUDs Trial Summary

This trial will test if treating sleep problems helps people with substance abuse stay in treatment for a longer time. Participants will complete surveys and wear a sleep watch, plus have "homework" for 4 weeks. The first 50 participants will receive typical treatment plus a sleep intervention program.

Who is the study for?

This trial is for adults over 18 with substance use disorders and insomnia, receiving care at specific clinics. They must have an Insomnia Severity Index score of 8+ and a diagnosis of insomnia. Excluded are those with severe medical/psychiatric issues, acute alcohol withdrawal, pregnant/breastfeeding women, or certain sleep conditions like severe apnea.Check my eligibility

What is being tested?

The study tests if Brief Behavioral Therapy for Insomnia (BBTI) helps people in substance abuse recovery stay in treatment longer. Participants will complete surveys, wear a sleep watch, keep a sleep diary as homework, and may be interviewed about their experience.See study design

What are the potential side effects?

Since BBTI is a non-medical therapy focusing on behavior changes to improve sleep patterns among individuals with SUDs, it does not have typical drug side effects; however participants might experience stress or discomfort from the change in sleeping habits or from wearing the sleep watch.

BBTI_SUDs Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+3 more

Secondary outcome measures

Change in Anxiety Measured by PROMIS Anxiety Scale

Change in Depression Measured by PROMIS Depression Scale

Change in Pain Measured by PROMIS Pain Interference Scale

+6 more

BBTI_SUDs Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BBTI GroupExperimental Treatment1 Intervention

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

Group II: SOC GroupActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brief Behavioral Therapy for Insomnia (BBTI)

2021

N/A

~200

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,347 Total Patients Enrolled

Traci J Speed, MD/PHDPrincipal InvestigatorJohns Hopkins University

Media Library

Brief Behavioral Therapy for Insomnia (BBTI) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05935735 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the fundamental aims of this experiment?

"This medical research endeavours to establish the practicality of Brief Behavioral Therapy for Insomnia (BBTI) over a period spanning up to 12 months. As part of this, they will assess Treatment Adherence Rate, Intervention Maintenance and Post-treatment Substance Use Disorder Relapse Rate as evaluated by Treatment Retention [days]."

Answered by AI

Are they still accepting participants for this research program?

"According to clinicaltrials.gov, this particular trial is not actively enrolling participants at present time; the initial posting was on July 1st 2023 and last updated June 29th 2023. Nonetheless, there are currently 588 other trials looking for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05935735.