Cognitive Behavioral Therapy for Insomnia in Alcohol Use Disorder

Overseen By Libby Cardoni

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Bipolar, Psychotic, PTSD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapies to assist individuals with insomnia who are also undergoing treatment for alcohol use disorder. It aims to enhance sleep quality and daytime functioning, potentially easing alcohol-related challenges. Participants will receive either Cognitive Behavioral Therapy for insomnia (CBTi), which uses non-medication strategies, or Sleep Hygiene Education (SHE), which focuses on altering habits and environments to improve sleep. Suitable candidates have struggled with insomnia and are in an abstinence program for alcohol use. Participants must be able to travel to Ann Arbor and have access to a device for video chats. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve treatment options for insomnia and alcohol use disorder.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy for insomnia (CBTi) and Sleep Hygiene Education (SHE) are safe, non-medication treatments. Studies have found that CBTi effectively reduces insomnia symptoms without major side effects. It can help with sleep problems and may even improve alcohol-related issues over time.

Sleep Hygiene Education (SHE) aims to enhance sleep by altering habits and environments that disrupt rest. Although specific studies on SHE's safety are limited, it is generally considered safe because it includes practical tips like maintaining a regular sleep schedule and making the bedroom more comfortable for sleeping.

Both treatments are well-tolerated, with no serious negative effects reported in research so far. This suggests they are safe options for people dealing with insomnia and alcohol use disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer non-medication approaches to tackling insomnia in individuals with alcohol use disorder. Unlike typical sleep medications that carry risks of dependency and side effects, Cognitive Behavioral Therapy for Insomnia (CBTi) focuses on changing thought patterns and behaviors related to sleep. This method can provide lasting benefits without medication. Sleep Hygiene Education (SHE), on the other hand, helps individuals improve sleep quality by adjusting lifestyle and environmental factors. Both offer promising alternatives to medication, aiming for sustainable, healthy sleep habits.

What evidence suggests that this trial's treatments could be effective for insomnia in alcohol use disorder?

In this trial, participants will receive either Cognitive Behavioral Therapy for insomnia (CBTi) or Sleep Hygiene Education (SHE). Research has shown that CBTi effectively reduces sleep problems in people with alcohol use disorder. Studies have found that CBTi not only improves sleep but also aids in alcohol recovery by addressing sleep issues that might cause a relapse. It consistently lowers insomnia severity in these individuals. Meanwhile, SHE focuses on changing habits and the environment to improve sleep, which can also benefit people with substance use issues. One study found that SHE can enhance sleep quality and reduce stress and anxiety in patients with substance abuse problems. Both treatments offer non-medication ways to improve sleep and support recovery. ^{1 3 6 7 8}

Who Is on the Research Team?

Todd Arnedt, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people with alcohol use disorder who have been sober for less than 12 weeks and also struggle with chronic insomnia. Participants need video chat access, can travel to Ann Arbor for sleep assessments, and are enrolling in an abstinence program. Those with bipolar, psychotic disorders, PTSD, pregnancy plans during the study or severe illnesses causing insomnia cannot join.

Inclusion Criteria

Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 weeks of abstinence

Ability to travel to Ann Arbor for sleep laboratory assessments

Planned enrollment into an abstinence-based treatment program

Exclusion Criteria

I am diagnosed with or suspected to have a sleep disorder that is not insomnia.

I have been diagnosed with bipolar, psychotic disorder, or PTSD.

I have a serious illness like cancer or dementia causing my insomnia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy for insomnia (CBTi) or Sleep Hygiene Education (SHE) to manage insomnia in the context of alcohol use disorder treatment

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for insomnia (CBTi)
• Sleep Hygiene Education (SHE)

Trial Overview The M-STAR Study is testing Cognitive Behavioral Therapy for Insomnia (CBTi) versus Sleep Hygiene Education (SHE) to see which better improves sleep and daytime functioning in individuals undergoing treatment for alcohol use disorder.

How Is the Trial Designed?

Group I: Sleep Hygiene Education (SHE) Experimental Treatment 1 Intervention

SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.

Group II: Cognitive Behavioral Therapy for insomnia (CBTi) Experimental Treatment 1 Intervention

CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.

Cognitive Behavioral Therapy for insomnia (CBTi) is already approved in United States, European Union for the following indications:

Approved in United States as CBT-I for:

• Insomnia in alcohol use disorder
• Insomnia

Approved in European Union as CBT-I for:

• Insomnia
• Sleep disorders

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

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]

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]

Brief behavioral treatment for insomnia (BBTI) is a 4-session program that can effectively reduce insomnia symptoms, such as difficulty falling asleep and waking up during the night, making it a practical option for non-psychologist health professionals to administer.

BBTI has shown promising results, including cases of full remission from insomnia, and ongoing clinical trials are exploring its efficacy in different treatment settings and delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. Gunn, HE., Tutek, J., Buysse, DJ.[2019]

A study involving 210 adults with insomnia compared three interventions: a cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI, and sleep hygiene education (SHE). All interventions significantly improved insomnia severity, anxiety, depressive symptoms, and quality of life, but there were no significant differences in effectiveness between the groups.

Self-help CBTI emerged as a preferred option in the stepped-care model for insomnia due to its comparable efficacy and adherence rates to workshop-based interventions, while being more accessible and requiring fewer resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial. Wong, KY., Chung, KF., Au, CH.[2021]

Cognitive-behavioral treatment for insomnia (CBTI-AD) significantly improved sleep quality and daytime fatigue in 17 abstinent alcohol-dependent patients compared to a behavioral placebo treatment, indicating its efficacy in this population.

While CBTI-AD enhanced subjective sleep measures and increased the number of treatment responders, it did not significantly affect relapse rates to alcohol use, suggesting that while it helps with sleep, its impact on drinking behavior may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia in alcohol dependent patients: a randomized controlled pilot trial. Arnedt, JT., Conroy, DA., Armitage, R., et al.[2022]

Cognitive behavioral therapy for insomnia (CBTi) is a highly effective non-drug treatment for insomnia, showing comparable efficacy to sleep medications in randomized control trials, with better long-term maintenance of benefits after treatment ends.

Due to its strong empirical support, both the National Institutes of Health and the American Academy of Sleep Medicine recommend CBTi as the standard treatment for insomnia, highlighting its importance in addressing the public health burden of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. Siebern, AT., Manber, R.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBTI) is the preferred treatment for chronic insomnia, but many patients opt for medication due to cost and availability issues.

Internet-based CBTI (I-CBTI) is well-accepted by patients and significantly improves insomnia symptoms, suggesting it could be a valuable alternative for those unable to access traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37342036/

Effect of Cognitive Behavioral Therapy for Insomnia on ... In this randomized clinical trial, CBT-I outperformed sleep hygiene in reducing insomnia symptoms and alcohol-related problems over time but had no effect on ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1087079225000024

Clinical Review Cognitive behavioral therapy for insomnia ... CBT-I effectively reduces insomnia severity across the spectrum of AUD, supporting wide implementation in AUD prevention and treatment settings.

3. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A234/8134751

0538 A Randomized Controlled Trial of CBT-I in Veterans in ... AbstractIntroduction. Although insomnia increases relapse risk in early recovery from Alcohol Use Disorder (AUD), no adequately powered ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05898-y

Telemedicine-delivered cognitive-behavioral therapy for ... Alcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available ...

5. sleepwakeadvisor.com sleepwakeadvisor.com/news/insomnia-and-alcohol-use-disorder-cbt-i/

CBT-I Is Effective for Comorbid Insomnia and Alcohol Use ... Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces insomnia severity among individuals with comorbid insomnia and alcohol ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8771184/

Telemedicine-delivered cognitive-behavioral therapy for ... Alcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality, but relapse rates are high even with available ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945722011467

Assessing cognitive behavioral therapy for insomnia in ... CBTi can be helpful in decreasing cannabis use and anxiety and depression. •. CBTi potentially to reduces inflammatory markers in insomnia. Abstract. Objective ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03493958

RCT of Web-Based Behavioral Sleep Intervention for ... Many people with alcohol use disorders have a sleep problem called insomnia. One treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Researchers ...