Cognitive Behavioral Therapy for Insomnia in Alcohol Use Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Bipolar, Psychotic, PTSD, others
No Placebo Group
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.
12345How 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.
46789Eligibility 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
+2 more
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.
+1 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 (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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Sleep Hygiene Education (SHE)Experimental Treatment1 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 Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial. [2021]Background/Objectives: Diverse low-intensity interventions are available as the entry points in the stepped-care model for insomnia. The study aims to compare a single-session cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI and sleep hygiene education (SHE) workshop among adults with insomnia in the community, in terms of insomnia severity, anxiety and depressive symptoms, the quality of life, treatment adherence and credibility.Participants: Two-hundred-and-ten Hong Kong adults with DSM-5 defined insomnia disorder for at least one month were recruited in the community.Methods: A three-arm-parallel, active-treatment-controlled and assessor-blinded randomized controlled trial was performed. Participants were block-randomized to the half-day CBTI workshop, self-help Internet-delivered CBTI and half-day SHE workshop groups evenly. Eight-week and 16-week post-baseline follow-ups were conducted. The primary outcome measure was the Insomnia Severity Index whereas the secondary measures included the Hospital Anxiety and Depression Scale, the Short-Form Six-Dimension Health Survey, treatment adherence and credibility.Results: All arms demonstrated a significant treatment effect on insomnia severity, anxiety and depressive symptoms and the quality of life. However, there was no difference between arms. Treatment adherence did not vary among the three groups, but treatment credibility of the self-help group dropped whereas that of the CBTI workshop group rose after interventions (p = .037).Conclusions: Despite the lack of between-group differences, self-help CBTI can be considered as the preferred entry point of the stepped-care model for insomnia. It demonstrates comparable efficacy and adherence rate to the workshop-based interventions, and is highly accessible and convenient with few resources required.
Insomnia and its effective non-pharmacologic treatment. [2018]Emerging data underscores the public health and economic burden of insomnia evidenced by increased health risks; increased health care utilization; and work domain deficits (absenteeism and reduced productivity). Cognitive behavioral therapy for insomnia (CBTi) is a brief and effective non-pharmacologic treatment for insomnia that is grounded in the science of sleep medicine and the science of behavior change and psychological theory, and in direct comparisons with sleep medication in randomized control trials that demonstrate that CBTi has comparable efficacy with more durable long-term maintenance of gains after treatment discontinuation. The high level of empirical support for CBTi has led the National Institutes of Health Consensus and the American Academy of Sleep Medicine Practice Parameters to make the recommendation that CBTi be considered standard treatment. The aim of this report is to increase awareness and understanding of health care providers of this effective treatment option.
Brief Behavioral Treatment of Insomnia. [2019]Cognitive behavioral treatment for insomnia (CBTI) is an effective treatment of insomnia; however, there are insufficient CBTI providers for the 10% to 25% of the population who have insomnia. Brief behavioral treatment for insomnia (BBTI) is a 4-session manualized treatment paradigm administrable in medical settings by nonpsychologist health professionals. BBTI is effective in reducing symptoms of insomnia, such as sleep onset latency, wake after sleep onset, and sleep efficiency. In some cases, BBTI resulted in full remission from insomnia. Ongoing clinical trials are further testing the efficacy of BBTI using alternative treatment deliveries and in primary medical care 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.
Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]Chronic insomnia is preferably treated with cognitive behavioral therapy for insomnia (CBTI), but many insomnia sufferers receive medication instead, likely because of high costs, lack of knowledge about optimal insomnia treatment among physicians, and lack of CBTI-trained professionals in mental health care. A possible solution is to offer CBTI through the Internet: I-CBTI. I-CBTI is generally acceptable to patients and greatly improves insomnia symptoms. We review the state of knowledge around I-CBTI and its effects. CBTI's effectiveness is influenced by treatment characteristics and patient-specific factors. We review potential factors that help identify which patients may benefit from I-CBTI.
Cognitive-behavioral therapy for insomnia in alcohol dependent patients: a randomized controlled pilot trial. [2022]In a randomized controlled trial, we evaluated the efficacy of cognitive-behavioral treatment for insomnia to improve sleep and daytime symptoms, and to reduce relapse in recovering alcohol dependent (AD) participants. Seventeen abstinent AD patients with insomnia (6 women, mean age 46.2 ± 10.1 years) were randomized to 8 sessions of cognitive-behavioral treatment for insomnia for AD (CBTI-AD, n=9) or to a behavioral placebo treatment (BPT, n=8). Subjective measures of sleep, daytime consequences of insomnia and AD, alcohol use, and treatment fidelity were collected at baseline and post-treatment. Diary-rated sleep efficiency and wake after sleep onset, and daytime ratings of General Fatigue on the Multidimensional Fatigue Inventory improved more in the CBTI-AD compared to the BPT group. In addition, more subjects were classified as treatment responders following CBTI-AD. No group differences were found in the number of participants who relapsed to any drinking or who relapsed to heavy drinking. The findings suggest that cognitive-behavioral insomnia therapy benefits subjective sleep and daytime symptoms in recovering AD participants with insomnia more than placebo. The benefits of treating insomnia on drinking outcomes are less apparent.
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.
We know CBT-I works, now what? [2022]Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be efficacious and now is considered the first-line treatment for insomnia for both uncomplicated insomnia and insomnia that occurs comorbidly with other chronic disorders (comorbid insomnia). The purposes of this review are to provide a comprehensive summary of the efficacy data (for example, efficacy overall and by clinical and demographic considerations and by CBT-I formulation) and to discuss the future of CBT-I (for example, what next steps should be taken in terms of research, dissemination, implementation, and practice).