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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
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 moreSecondary 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 moreAwards & 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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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,481 Total Patients Enrolled
American Academy of Sleep MedicineOTHER
25 Previous Clinical Trials
2,740 Total Patients Enrolled
Traci J Speed, MD/PHDPrincipal InvestigatorJohns Hopkins University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with restless legs syndrome.I do not have any health or mental conditions that would interfere with treatment.I have chosen not to receive mental health services at CC.I am 18 years old or older.