Clinical trial NCT03493958: RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder
Official title: Pilot RCT of Web-based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Dependence
Insomnia
Keywords: Alcohol Dependence
Alcohol Use Disorder
Insomnia
CBTI
Internet CBTI
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
name: University of Virginia
First posted: 2018-04-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: * 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

Primary outcomes:
measure: Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Average Time Spent on SHUTi After Logging in
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants With Technical Difficulties Using SHUTi or Tablet
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "How Comfortable Are You Using the Handheld Tablet?"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "How Easy Was SHUTi to Use?"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "How Convenient Was SHUTi to Use?"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "Extent of SHUTi Keeping Their Interest and Attention"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Likeability"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Appearance Likeability"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Privacy Concerns"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "SHUTi Satisfaction"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "Usefulness of SHUTi Information"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "Understanding SHUTi Information"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "Trust in SHUTi Information Provided"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Likelihood of Continued SHUTi Use When Sleep Problems Continue or Return
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Likelihood of Continued SHUTi Use Due to Technical Difficulties
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Evaluation and Utility Questionnaire: Participants Response to "Internet as a Delivery Method for Insomnia Intervention"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "SHUTi Helpfulness"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Increase in Insomnia Knowledge"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Quality of Life Improvement"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Mood Improvement"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Physical Activity Improvement"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Ability to Manage Insomnia"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Difficulties Falling Asleep"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Waking up in the Middle of the Night"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Difficulties Waking up Too Early"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Sleep Quality"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Impact and Effectiveness Questionnaire: Participants Response to "Improvement in Daytime Functioning"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Tablet as a Primary Device Used to Access SHUTi"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Working Internet Connection"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to Connection Problem to SHUTi
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Slow Internet Connection"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Problems With Device"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Forgetting to Access SHUTi"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Not Wanting to Access SHUTi"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Personal Issues Interfering With SHUTi Use"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Work Issues Interfering With SHUTi Use"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Difficulty Navigating SHUTi"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Difficulty Understanding SHUTi Content"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "SHUTi Not Being Useful"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to SHUTi Program Being Too 'Wordy'
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to Screen Being Too Hard to Read
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Too Much to do in SHUTi"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Diaries Taking Too Long to Complete"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "SHUTi Helping With Insomnia"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Too Many Sleep Rules"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Spouse/Significant Other/Roommate Having Issues With Participant Using SHUTi"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Difficulty With Sleep Restriction Instructions"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Who Responded to "Sleep Efficiency Not Improving"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Too Much Homework"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Internet Intervention Adherence Questionnaire: Participants Response to "Homework Difficulty"
timeFrame: 9-11 Weeks post SHUTi initiation
measure: Average Login Counts
timeFrame: 6-7 months post discharge from inpatient admission for this study
measure: Mean Diary Completion Counts
timeFrame: 6-7 months post discharge from inpatient admission for this study
measure: Average Number of Sessions Completed
timeFrame: 9-11 Weeks post SHUTi initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Gwenyth R Wallen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: