Cognitive Behavioral Therapy for Insomnia and Alcohol Abuse
(ReTRAIN Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Missouri-Columbia
Disqualifiers: Age ≥50, Mania, Seizure disorder, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have conditions like mania or seizure disorder, which are contraindications for the therapy, you might need to discuss your medications with the trial team.
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) and Digital CBT-I (dCBT-I) for insomnia and alcohol abuse?
Research shows that digital cognitive behavioral therapy for insomnia (dCBT-I) is effective in treating insomnia and improving sleep quality. It is also considered a promising approach for individuals with alcohol use disorder (AUD) who often experience sleep problems, although specific trials for this group are still ongoing.
12345Is digital cognitive behavioral therapy for insomnia safe for humans?
The research does not specifically address safety concerns, but digital cognitive behavioral therapy for insomnia (dCBT-I) is widely studied and recommended as a first-line treatment, suggesting it is generally considered safe.
14567How is Cognitive Behavioral Therapy for Insomnia (CBT-I) different from other treatments for insomnia and alcohol abuse?
CBT-I is unique because it specifically targets insomnia symptoms, which are common in people with alcohol use disorders, and it can be delivered digitally (dCBT-I), making it accessible remotely. Unlike other treatments that may focus solely on alcohol use, CBT-I addresses sleep issues that can contribute to alcohol relapse, potentially improving both sleep and alcohol-related outcomes.
89101112Eligibility Criteria
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.Inclusion Criteria
Report heavy drinking in a typical week in the past month
Meet DSM-5 criteria for Alcohol Use Disorder
Meet DSM-5 and research diagnostic criteria for Insomnia Disorder
Exclusion Criteria
I do not have mania or a seizure disorder.
Are already receiving behavioral treatment for insomnia or alcohol use
I need urgent care for severe mental health symptoms.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Cognitive Behavioral Therapy for Insomnia (CBT-I) once a week for five weeks
5 weeks
5 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
1-, 3-, and 6-month follow-ups
Participant Groups
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.
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.
Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United States, United Kingdom for the following indications:
🇺🇸 Approved in United States as CBT-I for:
- Insomnia
- Depression
🇪🇺 Approved in European Union as CBT-I for:
- Insomnia
- Depression
🇺🇸 Approved in United States as Somryst for:
- Chronic Insomnia
🇬🇧 Approved in United Kingdom as Sleepio for:
- Insomnia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Missouri-ColumbiaColumbia, MO
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Who Is Running the Clinical Trial?
University of Missouri-ColumbiaLead Sponsor
References
Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life.
Online cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia among individuals with alcohol use disorder: study protocol for a randomized controlled trial. [2022]Label="ABSTRACT" NlmCategory="UNASSIGNED">Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection (n = 10). Phase II will be an RCT powered to examine preliminary intervention efficacy (n = 30 per group). Participants for this study must meet criteria for "moderate to severe" insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time.
Using network intervention analysis to explore associations between participant expectations of and difficulties with cognitive behavioural therapy for insomnia and clinical outcome: A proof of principle study. [2022]Research about predictors of response to cognitive behaviour therapy for insomnia (CBT-I) is ongoing. We examined any whether pre-intervention expectations or post-intervention appraisals of difficulties in utilizing face to face (FtF) or digital (dCBT-I) versions of the therapy were associated with outcome.
Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]Digital cognitive behavior therapy for insomnia (dCBT-I) is an effective treatment in alleviating insomnia. This study examined the effect of dCBT-I for improving sleep quality in patients with insomnia complaints from a clinical population in a real-world setting.
The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. [2021]Digital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress.
Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. [2021]Although cognitive behavioural therapy for insomnia (CBT-I) has been recommended the initial therapy for insomnia, its clinical usage remains limited due to the lack of therapists. Digital CBT-I (dCBT-I) can potentially circumvent this problem. This meta-analysis aims to evaluate the short-term and long-term efficacy of dCBT-I for adults with insomnia.
Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. [2023]Although digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in many randomized clinical trials and is recommended as a first-line treatment option, few studies have systematically examined its effectiveness, engagement, durability, and adaptability in clinical settings.
Cognitive behavioral therapy for insomnia among young adults who are actively drinking: a randomized pilot trial. [2022]More than half of young adults at risk for alcohol-related harm report symptoms of insomnia. Insomnia symptoms, in turn, have been associated with alcohol-related problems. Yet one of the first-line treatments for insomnia (Cognitive Behavioral Therapy for Insomnia or CBT-I) has not been tested among individuals who are actively drinking. This study tested (1) the feasibility and short-term efficacy of CBT-I among binge-drinking young adults with insomnia and (2) improvement in insomnia as a predictor of improvement in alcohol use outcomes.
Protocol for the Project SAVE randomised controlled trial examining CBT for insomnia among veterans in treatment for alcohol use disorder. [2021]As many as 74% of veterans with alcohol use disorders (AUDS) report symptoms of insomnia. Insomnia represents a barrier to alcohol treatment because insomnia symptoms (1) may lead to relapse among those who use alcohol to help them sleep and may negatively impact (2) executive functions and (3) emotion regulation skills. Cognitive-behavioural therapy for insomnia (CBT-I) is an efficacious first-line treatment for insomnia; however, no research has examined the impact of CBT-I on individuals' response to alcohol treatment. In the Sleep and Alcohol for Veterans (Project SAVE) randomised controlled trial, we hypothesise that CBT-I will enhance the efficacy of alcohol treatment among Veterans with insomnia by enhancing their abilities to attend to treatment, regulate emotions and initiate sleep without alcohol.
Effect of Cognitive Behavioral Therapy for Insomnia on Alcohol Treatment Outcomes Among US Veterans: A Randomized Clinical Trial. [2023]Three of 4 adults in treatment for alcohol use disorder (AUD) report symptoms of insomnia. Yet the first-line treatment for insomnia (cognitive behavioral therapy for insomnia, CBT-I) is often delayed until abstinence is established.
Insomnia treatment effects among young adult drinkers: Secondary outcomes of a randomized pilot trial. [2022]Cognitive behavioral therapy for insomnia (CBT-I) has moderate-to-large effects on insomnia among young adult drinkers, with preliminary data indicating that improvements in insomnia may have downstream effects on alcohol-related consequences. However, the mechanism(s) by which insomnia treatment may facilitate reductions in alcohol-related problems is unclear. Secondary outcome data from a randomized pilot trial were used to examine CBT-I effects on four proposed mediators of the insomnia/alcohol link: alcohol craving, delay discounting, negative affect, and difficulties with emotion regulation.
Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial. [2023]Alcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available treatments. Insomnia is a robust predictor of relapse and pilot studies have shown that CBT for insomnia improves insomnia and daytime functioning in adults with AUD and insomnia. The impact of CBT for insomnia on relapse, however, is unclear. This trial will compare telemedicine-delivered CBT for insomnia (CBT-TM) with sleep hygiene education (SHE-TM) on improving insomnia/sleep, daytime symptom, and drinking outcomes in treatment-seeking AUD adults with insomnia. The study will also determine the effects of treatment on sleep mechanisms and their association with clinical outcomes.