An interventional study of Cognitive Behavioral Therapy for insomnia (CBTi) and Sleep Hygiene Education (SHE) in Insomnia and Alcohol Use Disorder, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 134 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CBTi is a non-medication therapy that includes cognitive and behavioral treatment components.
Behavioral: Cognitive Behavioral Therapy for insomnia (CBTi)
SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep.
Behavioral: Sleep Hygiene Education (SHE)
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Score from the insomnia severity index (ISI)
The ISI is a 7-item self-report assessment of the nature, severity and impact of insomnia. Scores range from 0-28 with higher scores suggesting more clinically significant insomnia.
Time frame: Immediately post treatment
Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)
The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.
Time frame: Immediately post treatment
Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
The MFI is a 20-item assessment that provides an overall fatigue score (20-100) in addition to 5 separate dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Sub-scale scores range from 4-20 with higher scores indicating higher levels of fatigue.
Time frame: Immediately post treatment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data will be shared through the National Institute of Mental Health (NIMH) Data Archive. Only information relevant to the research project will be shared, which may include demographic information such as gender and age, responses to surveys and results found from the research project. Participants identifying data will not be shared in any way and information related to participants will be given a different random identifier known as a Global Unique Identifier or GUID. This number will not coincide with any identifier for data stored on University of Michigan study databases.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data will be available following data collection and for 1-2 years following the end of the study grant.
Access criteria: Data shared via the NIMH database is accessible by those associated with NIH institutions who have also signed data sharing agreements.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →