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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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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