RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder
Condition: Alcohol Use Disorder; Alcohol Dependence; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      Background:

      Many people with alcohol use disorders have a sleep problem called insomnia. One treatment is
      Cognitive Behavioral Therapy for Insomnia (CBT-I). Researchers want to study adults
      experiences with a web-based CBT-I program called SHUTi.

      Objective:

      To test if a web-based insomnia therapy program works well and helps people with alcohol use
      disorders.

      Eligibility:

      Adults ages 18-65 who joined another protocol and have been an inpatient on that protocol at
      least 14 days.

      Design:

      Participants will be screened with questions about insomnia. They will wear a device on their
      wrist and finger for one night while sleeping. This checks for sleep apnea.

      Participants will complete 1 of 2 programs:

        1. SHUTi: Participants will start using the program in the hospital and finish it about 6
           weeks later. They will get a computer tablet to access SHUTi at least 3 times a week.
           They will get surveys, stories, videos, and interactive data about sleep. They will
           complete at least 5 daily sleep diaries every week. SHUTi will be customized based on
           the diaries.

        2. Education-only program: This is like SHUTi but it is not interactive and is not
           customized. Participants will access it at least once a week. They will finish at their
           own pace within 6 weeks. These participants may access SHUTi later.

      All participants will wear a device on their wrist for 4 straight days at several different
      time points. It records activity and sleep data. They will do this 3 times.

      Participants will answer questions about the program before starting it and after finishing.
      Interviews will be audio recorded.

      Participants will do follow-up surveys 6-7 months after they are discharged from the
      hospital.
    

Detailed description: 
      Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. The
      prevalence of insomnia in individuals with alcohol dependence is estimated to be between
      36-91% and after two weeks of alcohol detoxification, as many as 65% of these individuals
      still experience "sleep problems." Cognitive behavioral therapy for insomnia (CBT-I) is an
      efficacious non-pharmacological treatment for insomnia and is recommended as a first-line
      treatment for adults with chronic insomnia disorder. CBT-I has been associated with more
      rapid and "durable" improvement in sleep outcomes, even when compared with other
      nonpharmacological treatments. Internet-based CBT-I (ICBT-I or eCBT-I for "electronic") could
      play a key role in the dissemination of this behavioral sleep intervention, given the paucity
      of trained clinicians able to provide CBT-I in person and other logistical/cost concerns.
      SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound internet
      intervention for insomnia. The SHUTi program tailors specific recommendations based on
      participant responses to sleep diaries and other input within the program. Despite the
      promise of internet-based CBT-I interventions, very little is known about their effectiveness
      among individuals with AUD: to date, no RCTs exist examining the feasibility/effectiveness of
      an internet-based CBT-I program among individuals recovering from AUD. This is a two-phase
      randomized controlled trial assessing feasibility/acceptability and effectiveness of the
      SHUTi program for research participants at the NIH Clinical Center. Phase I will be focused
      on assessing feasibility and effectiveness of program delivery and data collection (n=10).
      Phase II will be a pilot RCT powered to examine intervention effectiveness (n=20 per group).
      All participants enrolled in this study will first be admitted under the screening and
      assessment protocol on the 1SE clinic (14-AA-0181), which includes adults over 18 years of
      age seeking treatment for alcohol rehabilitation. Participants for this study must also meet
      criteria for "mild to severe" insomnia. Individuals randomized to the intervention group will
      receive six sessions of the SHUTi intervention (one completed while inpatient, the rest while
      outpatient) and individuals randomized to the control group will receive an educational
      web-based program. The goals of the study are as follows: 1) assess the feasibility and
      acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia
      (Phase I ), 2) compare the efficacy of CBT-I versus control group with respect to primary and
      secondary outcome variables (Phase II), and 3) explore specific domains associated with
      improved outcomes: e.g. demographic, psychiatric, and/or drinking-related factors (Phase II).
      Primary outcome measures include changes in insomnia severity over time and changes in
      actigraphy-recorded sleep efficiency over time.
    

Intervention name(s): Sleep Healthy Using the Internet (SHUTi)
Intervention type(s): Behavioral
Intervention description(s): The SHUTi program is an automated, interactive, internet-based intervention based on well-established face-to-face cognitive behavioral therapy for insomnia (CBT-I) components including sleep restriction, stimulus control, sleep hygiene, cognition
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Alcohol Use Disorder; Insomnia; CBTI; Internet CBTI