Cognitive Behavioral Therapy for Insomnia and Alcohol Abuse

(ReTRAIN Trial)

Overseen By Rebecca Patterson, BSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Age ≥50, Mania, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

256 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 4 5 6 7}

How 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. ^{8 9 10 11 12}

Eligibility 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.

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

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview 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.

Participant Groups

Group I: CBT-I Experimental Treatment 1 Intervention

Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.

Group II: Waitlist control Active Control 1 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 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

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Findings from Research

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

This study is testing the feasibility and efficacy of an Internet-based cognitive behavioral therapy for insomnia (CBT-I) program called SHUTi among individuals recovering from alcohol use disorder (AUD) with moderate to severe insomnia, involving 40 participants across two phases.

The first phase will assess how acceptable and feasible the program is, while the second phase will compare the effectiveness of SHUTi against a control educational program, focusing on improvements in insomnia severity and sleep efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Brooks, AT., Tuason, RT., Chakravorty, S., et al.[2022]

In a study of 101 adults undergoing cognitive behaviour therapy for insomnia (CBT-I), both pre-intervention expectations and post-intervention difficulties in applying the therapy were found to significantly predict treatment outcomes at 9 weeks and 6 months.

Face-to-face (FtF) therapy showed a stronger association with positive outcomes at 9 weeks compared to digital CBT-I, but this advantage diminished by the 6-month follow-up, suggesting that self-confidence in using sleep restriction techniques is crucial for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Scott, J., Vedaa, Ø., Sivertsen, B., et al.[2022]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

In a study involving 1720 adults with insomnia, digital cognitive behavioral therapy for insomnia (dCBT-I) significantly reduced intraindividual variability in sleep metrics, particularly in sleep onset latency, which is crucial for improving sleep quality.

The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting the effectiveness of dCBT-I as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Vestergaard, CL., Vedaa, Ø., Simpson, MR., et al.[2021]

Digital cognitive behavioural therapy for insomnia (dCBT-I) significantly reduces insomnia severity, with a mean difference of -5.00 on the Insomnia Severity Index (ISI) immediately after treatment, based on a meta-analysis of 33 studies involving nearly 9,400 participants.

The benefits of dCBT-I are sustained over time, showing continued improvement at both short-term (4 weeks to 6 months) and 1-year follow-ups, making it a promising alternative to traditional face-to-face therapy, which, while slightly more effective, falls within a non-inferiority margin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. Soh, HL., Ho, RC., Ho, CS., et al.[2021]

Digital cognitive behavioral therapy for insomnia (dCBT-I) was found to be more effective than medication alone in reducing insomnia symptoms, with significant improvements in Pittsburgh Sleep Quality Index scores over 6 months for dCBT-I and combination therapy.

While dCBT-I showed comparable effectiveness to combination therapy, its benefits were less stable over time, indicating that while it is a strong treatment option, further research is needed to understand its long-term reliability in different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. Lu, M., Zhang, Y., Zhang, J., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) was found to be feasible and effective in reducing insomnia symptoms among binge-drinking young adults, with a 56% reduction in symptoms compared to 32% in the sleep hygiene group.

While CBT-I did not directly affect alcohol use outcomes, it indirectly improved alcohol-related consequences by reducing insomnia severity, suggesting that better sleep may help mitigate alcohol-related problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia among young adults who are actively drinking: a randomized pilot trial. Miller, MB., Deroche, CB., Freeman, LK., et al.[2022]

A study involving 80 veterans with alcohol use disorders and insomnia will investigate whether cognitive-behavioral therapy for insomnia (CBT-I) can improve their response to alcohol treatment by enhancing sleep and emotional regulation.

The trial will compare CBT-I to a single-session sleep hygiene education, measuring outcomes like insomnia severity and heavy-drinking days, with results expected by July 2021, aiming to provide insights into effective treatments for veterans struggling with both insomnia and alcohol use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the Project SAVE randomised controlled trial examining CBT for insomnia among veterans in treatment for alcohol use disorder. Miller, MB., Metrik, J., McGeary, JE., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly reduced insomnia severity and improved sleep efficiency in veterans with alcohol use disorder compared to a sleep hygiene control, indicating its effectiveness as a treatment for insomnia even early in AUD treatment.

Improvements in insomnia symptoms through CBT-I were associated with a reduction in alcohol-related problems, suggesting that addressing sleep issues may help improve overall alcohol use outcomes, although CBT-I did not affect the frequency of heavy drinking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Cognitive Behavioral Therapy for Insomnia on Alcohol Treatment Outcomes Among US Veterans: A Randomized Clinical Trial. Miller, MB., Carpenter, RW., Freeman, LK., et al.[2023]

Cognitive behavioral therapy for insomnia (CBT-I) significantly reduced alcohol craving and improved the ability to delay gratification for larger rewards in young adult drinkers with insomnia, based on a pilot trial with 56 participants.

These findings suggest that treating insomnia may help address alcohol-related issues, indicating a potential mechanism by which better sleep can lead to reduced alcohol consumption, although further research is needed to confirm this link.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia treatment effects among young adult drinkers: Secondary outcomes of a randomized pilot trial. Miller, MB., Freeman, L., Park, CJ., et al.[2022]

This study will evaluate the effectiveness of telemedicine-delivered Cognitive Behavioral Therapy for Insomnia (CBT-TM) compared to Sleep Hygiene Education (SHE-TM) in improving sleep and reducing relapse rates in 150 adults with Alcohol Use Disorder (AUD) and chronic insomnia.

The trial aims to provide insights into how treating insomnia can impact clinical outcomes in AUD, including sleep mechanisms measured by EEG delta activity, which could help improve treatment strategies for individuals struggling with both conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial. Arnedt, JT., Cardoni, ME., Conroy, DA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia among young adults who are actively drinking: a randomized pilot trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Protocol for the Project SAVE randomised controlled trial examining CBT for insomnia among veterans in treatment for alcohol use disorder. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Cognitive Behavioral Therapy for Insomnia on Alcohol Treatment Outcomes Among US Veterans: A Randomized Clinical Trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Insomnia treatment effects among young adult drinkers: Secondary outcomes of a randomized pilot trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial. [2023]