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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA028158 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBTi) | Other | CBTi is a non-medication therapy that includes cognitive and behavioral treatment components. |
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| Sleep Hygiene Education (SHE) | Other | SHE is a non-medication therapy that focuses on identifying and changing several behavioral and environmental factors that can interfere with sleep. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for insomnia (CBTi) | Behavioral | CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Immediately post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Todd Arnedt, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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.
The data will be available following data collection and for 1-2 years following the end of the study grant.
Data shared via the NIMH database is accessible by those associated with NIH institutions who have also signed data sharing agreements.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2022 | Sep 26, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000437 | Alcoholism |
| D000070263 | Sleep Hygiene |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Sleep Hygiene Education (SHE) | Behavioral | SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine. |
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| D001523 |
| Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |