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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for 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.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBTi) in Alcohol Use Disorder?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBTi) is an effective treatment for insomnia, with benefits comparable to sleep medications and longer-lasting effects. It has been successfully used in various forms, including internet-delivered and brief behavioral treatments, to improve sleep and related symptoms, making it a promising option for those with alcohol use disorder who also experience insomnia. ^{1 2 3 4 5}

How is Cognitive Behavioral Therapy for Insomnia (CBT-I) unique for treating insomnia in people with alcohol use disorder?

CBT-I is unique because it directly addresses insomnia in people who are actively drinking or recovering from alcohol use disorder, potentially improving sleep and reducing alcohol-related problems, unlike other treatments that may not focus on both issues simultaneously. ^{4 6 7 8 9}

Research Team

Todd Arnedt, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 (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]

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 (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]

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]

References

1. England 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. [2021]

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

Insomnia and its effective non-pharmacologic treatment. [2018]

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

Brief Behavioral Treatment of Insomnia. [2019]

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

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

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

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia in alcohol dependent patients: a randomized controlled pilot trial. [2022]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

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

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

We know CBT-I works, now what? [2022]