RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder

Overview

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 people s 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.

Full Title of Study: “Pilot RCT of Web-based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • Other: SHUTi Control
    • The control group of the study will be standard insomnia education/monitor only (insomnia education web-based program that participants access and read at their own pace contains no customization of program based on sleep diary responses). Participants in the control group are given educational information (like they might see on WebMD or National Sleep Foundation websites), but are left to apply it themselves.
  • Behavioral: SHUTi
    • The SHUTi program is an automated, interactive, internet- based intervention based on well established face-to- face CBT-I components including sleep restriction, stimulus control, sleep hygiene, cognition

Arms, Groups and Cohorts

  • Other: Education/control
    • Education/monitor only (insomnia education web-based program that participants access and read at their own pace contains no customization of program based on sleep diary responses). Participants in the control group are given educational information (like they might see on WebMD or National Sleep Foundation websites), but are left to apply it themselves.
  • Experimental: Intervention Group
    • 6 sessions modules of SHUTi intervention (at least one module completed while inpatient, the rest while outpatient): In SHUTi, customization is based on multiple variables, including sleep diary responses. The SHUTi program tailors specific recommendations based on sleep diary responses or other input within the program (e.g., responses on the Dysfunctional Beliefsand Attitude Scale trigger recommendations for specific cognitive restructuring strategies).

Clinical Trial Outcome Measures

Primary Measures

  • Phase II: Primary outcome measures include changes in insomnia severity over time and changes in actigraphy- recorded sleep efficiency over time.
    • Time Frame: 9-aa weeks post discharge
    • SHUTi generated Insmonia Severity Index and actigraphy recorded sleep efficiency
  • Phase I: Assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery
    • Time Frame: Before inpatient discharge and 9-11 weeks post discharge
    • Evaluate the feasibility,acceptability, and utility of a web-based CBT for Insomnia in the AUD population

Secondary Measures

  • TLFB and PACS
    • Time Frame: Post study intervention/education only program and 6-7 months post discharge
    • The PACS is a clinical tool for practitioners to measure alcohol craving. It is a five- item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking along with ability to resist drinking. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
  • sleep disturbance, daytime sleepiness, anxiety/depression, fatigue, selfefficacy for sleep, dysfunctional beliefs about sleep, and functional outcomes
    • Time Frame: Pre-study intervention/education only program and post-completion of the study intervention/education only program
    • The FOSQ-10 is a 10-item abbreviated version of the original 30 item instrument used to evaluate quality of life in relation to daytime sleepiness. The Pittsburgh Sleep Quality Index (PSQI) is a 19-item, self-rated questionnaire used to measure sleep quality and disturbances over a 30-day time interval. The Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) measure has been used in a variety of study designs, including longitudinal, cross-sectional, and randomized control trials, with acceptable psychometric properties. ). The Epworth Sleepiness Scale (ESS) is an eight-item self-administered questionnaire that provides a measure of an individual s general level of excessive daytime sleepiness over a one week time period (Johns, 1991). The SE-S includes nine items used to measure the level of confidence a person has in performing behaviors that might be helpful in initiating sleep. The DBAS-16 is a 16-item questionnaire that assesses sleep-related cognitions
  • Actigraphy-generated measures
    • Time Frame: Pre-study intervention/education only program, 3-4 weeks post- discharge, Post- completion of the study intervention/education only program
    • The main outcome of interest will be improvements in sleep efficiency from baseline to follow-up assessment periods. The watch also provides measures of total sleep time (TST), wake after sleep onset (WASO), sleep onset latency (SOL), number of awakenings (NWAK), and time in bed (TIB).

Participating in This Clinical Trial

Inclusion Criteria

Participants will be eligible for this study if they:

  • Are 18 65 years old
  • A score of 10 or higher on the Insomnia Severity Index*
  • Are admitted as a treatment-seeking inpatient on 1SE under protocol 14-AA-0181 (signing both the clinical and research consent)
  • Have been inpatient for at least 14 days prior to consent/screening
  • Can speak, understand, and write in English
  • Are able to comply with study requirements (including ability to access the Internet at least 2x per week)

Exclusion Criteria

Participants will be ineligible for this study if they:

  • Are pregnant
  • Are a prisoner
  • Report a physician diagnosis of moderate to severe obstructive sleep apnea (OSA) OR test positive for moderate to severe OSA as documented with an Apnea Hypopnea Index of 15 events/hour based on WatchPAT testing results
  • Have irregular sleep schedules that prevent the ability to follow treatment recommendations (i.e. usual bedtimes outside of 8:00 pm to 2:00 am or arising times outside of 4:00 am to 10:00 am)
  • Meet SCID-5/DSM-5 criteria for opioid use disorder in the past year
  • Meet SCID-5/DSM-5 criteria for severe cocaine use disorder and/or severe cannabis use disorder in the past year
  • Meet diagnostic criteria for an unstable or serious psychiatric condition (schizophrenia, bipolar, major depressive disorder not currently in remission) – based on diagnosis from the SCID for DSM-5
  • Are participating in any experimental pharmacological intervention study
  • Presence of unstable or serious medical/neurologic illness at PI and MAI discretion

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Institutes of Health Clinical Center (CC)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alyssa Todaro-Brooks, Ph.D., Principal Investigator, National Institutes of Health Clinical Center (CC)

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