Alcohol Use Disorder, Insomnia
Conditions
Keywords
Cognitive Behavioral Therapy, Sleep Hygiene
Brief summary
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.
Interventions
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
BEHAVIORALSleep Hygiene Education (SHE)
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
Sponsors
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 months of abstinence * Planned enrollment into an abstinence-based treatment program * Meet probable DSM-5 criteria for chronic insomnia * Access to a video chat-capable device and reliable Wi-Fi network
Exclusion criteria
* Diagnosis of, or high suspicion for, sleep disorders other than insomnia * Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (PTSD) * Terminal or progressive physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia), or presence of an unstable medical condition that is the specific cause of insomnia * Self-reported pregnancy or intention to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score from the insomnia severity index (ISI) | Immediately post treatment | 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. |
| Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB) | Immediately post treatment | The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale | Immediately post treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJ Todd Arnedt, Ph.D.
University of Michigan
Outcome results
None listed