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Behavioral Intervention

CBT-I for Insomnia (ReTRAIN Trial)

N/A

Waitlist Available

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

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

ReTRAIN Trial 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.Check my eligibility

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.See study design

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.

ReTRAIN Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Alcohol-related consequences

Drinking quantity

Insomnia Symptoms

Secondary outcome measures

Alcohol craving

Alcohol to help with sleep

Delay discounting

+6 more

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624

Hematoma R side abdomen

Severe vaginal bleeding and pain

Chest pain in a patient with CAD

Asthma

100%

80%

60%

40%

20%

Study treatment Arm

Antidepressant + Desensitization

Antidepressant + Cognitive Behavioral

ReTRAIN 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

~1800

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

361 Previous Clinical Trials

627,738 Total Patients Enrolled

9 Trials studying Insomnia

778 Patients Enrolled for Insomnia

Frequently Asked Questions

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

Which specific criteria determine the inclusion of individuals into this research study?

"To qualify for participation in this investigation, individuals must exhibit symptoms of insomnia and fall within the age bracket of 18 to 49 years. The study aims to recruit approximately 256 subjects."

Answered by AI

Is the enrollment for this clinical trial currently open?

"As indicated on clinicaltrials.gov, recruitment for this study is currently closed. The trial was initially listed on March 1st, 2024, and underwent its latest update on February 23rd of the same year. While enrollment for this specific trial is inactive at present, it's worth noting that there are a total of 238 other trials actively seeking participants."

Answered by AI

Are individuals aged 70 and above being included in the recruitment for this study?

"Participants eligible for this research study must fall within the age range of 18 to 49 years. There are a total of 28 trials targeting individuals under 18 and another 186 focusing on those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep as a Mechanism of Change in Alcohol Use

Mary E Miller 2024. "Sleep as a Mechanism of Change in Alcohol Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06286774.

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