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Behavioral Intervention
Cognitive Behavioral Therapy for Insomnia and Alcohol Abuse (ReTRAIN Trial)
N/A
Recruiting
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Have symptoms requiring immediate clinical attention (e.g., psychosis, suicide plan)
Moderate to severe sleep apnea that is untreated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if treating insomnia can help people with alcohol use problems."
Who is the study for?
This trial is for adults under 50 who drink heavily, have been diagnosed with both Insomnia Disorder and Alcohol Use Disorder according to DSM-5 criteria. It's not for those with mania, seizure disorders, severe sleep apnea (unless treated), or those already in treatment for insomnia or alcohol issues.
What is being tested?
The study tests if treating insomnia with Cognitive Behavioral Therapy (CBT-I) can help improve alcohol use problems. Participants will receive CBT-I sessions aimed at improving their sleep patterns.
What are the potential side effects?
CBT-I generally has no physical side effects as it's a non-medical therapy involving talking and behavior change strategies. However, changing sleep habits can sometimes lead to temporary discomfort like fatigue.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need urgent care for severe mental health symptoms.
Select...
I have untreated sleep apnea that is moderate to severe.
Select...
I am 50 years old or older.
Select...
I am unable to understand and agree to the study's details on my own.
Select...
I do not have mania or a seizure disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alcohol-related consequences
Drinking quantity
Insomnia Symptoms
Secondary study objectives
Alcohol craving
Alcohol to help with sleep
Delay discounting
+6 moreSide effects data
From 2015 Phase 2 & 3 trial • 150 Patients • NCT007676241%
Hematoma R side abdomen
1%
Severe vaginal bleeding and pain
1%
Chest pain in a patient with CAD
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antidepressant + Desensitization
Antidepressant + Cognitive Behavioral
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: CBT-IExperimental Treatment1 Intervention
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Group II: Waitlist controlActive Control1 Intervention
Control participants will receive CBT-I at the end of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1750
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
380 Previous Clinical Trials
628,506 Total Patients Enrolled
1 Trials studying Alcohol Abuse
325 Patients Enrolled for Alcohol Abuse