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

Study Overview
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Brief Summary
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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: 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. 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
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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.

Official Title
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Pilot RCT of Web-based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder

Conditions
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Alcohol Use Disorder, Alcohol Dependence, Insomnia

Intervention / Treatment
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* Behavioral: Sleep Healthy Using the Internet (SHUTi)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility and acceptability of Sleep Healthy Using the Internet (SHUTi) for CBT-I<br>Individuals with alcohol use disorder (AUD) in recovery with insomnia completed six online classes that include interactive educational content and case studies about insomnia and its precipitating factors. These sessions are designed to parallel traditional (in-person) cognitive behavioral therapy for insomnia (CBT-I) sessions and are tracked and customized. New sessions are available seven days after completion of the previous session. The program includes a variety of interactive features, including goal setting, feedback based on user-identified symptoms, animations, quizzes, vignettes, and video-based expert explanations. Participants have maximum of 9-11 weeks to complete the six sessions. | Behavioral: Sleep Healthy Using the Internet (SHUTi)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internet Evaluation and Utility Questionnaire: Average Number of Log in to SHUTi Per Week During the Last 9 Weeks | Average number of times participants logged into SHUTi 9-11 weeks after SHUTi initiation was measured using a survey item, On average, how many times did you log in to SHUTi per week during the last 8-9 weeks? | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Average Time Spent on SHUTi After Logging in | Average amount of time (in minutes) participants spent on SHUTi in the last 9-11 weeks was measured using a survey item, When you logged in, on average, how much time did you spend on SHUTi? | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants With Technical Difficulties Using SHUTi or Tablet | Participants expressed technical difficulties with SHUTi or study provided tablet using a survey item, Did you have technical difficulties with SHUTi or your tablet? with a yes or no response | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to How Comfortable Are You Using the Handheld Tablet? | Participants expressed comfort using the tablet with a survey item on a 5-point scale, How comfortable are you using the handheld tablet? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to How Easy Was SHUTi to Use? | Participants ease of using SHUTi was measured with a survey item on a 5-point scale, How easy was SHUTi to use? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to How Convenient Was SHUTi to Use? | Participants expressed convenience of using SHUTi with a survey item on a 5-point scale, How convenient was SHUTi to use? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to Extent of SHUTi Keeping Their Interest and Attention | Participants expressed extent of SHUTi keeping their interest and attention with a survey item on a 5-point scale, How much did SHUTi keep your interest and attention? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to SHUTi Likeability | Participants expressed SHUTi likeability with a survey item on a 5-point scale, How much did you like SHUTi? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to SHUTi Appearance Likeability | Participants expressed SHUTi appearance likability with a survey item on a 5-point scale, How much did you like the way SHUTi looked? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to SHUTi Privacy Concerns | Participants expressed SHUTi privacy concerns with a survey item on a 5-point scale, How worried were you about your privacy when using SHUTi? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to SHUTi Satisfaction | Participants expressed satisfaction with SHUTi with a survey item on a 5-point scale, How satisfied were you with SHUTi? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to Usefulness of SHUTi Information | Participants expressed usefulness of SHUTi information with a survey item on a 5-point scale, How useful did you find the information in SHUTi? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to Understanding SHUTi Information | Participants expressed how easy the SHUTi information was to understand with a survey item on a 5-point scale, How easy is the information to understand? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to Trust in SHUTi Information Provided | Participants expressed how well they trusted the SHUTi information provided with a survey item on a 5-point scale, How much did you feel you could trust the information? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Likelihood of Continued SHUTi Use When Sleep Problems Continue or Return | Participants expressed their likelihood of continued SHUTi when sleep problems continue or return with a survey item on a 5-point scale, If sleep difficulties were to continue or return, how likely would you be to continue to use SHUTi? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Likelihood of Continued SHUTi Use Due to Technical Difficulties | Participants expressed their likelihood of continued SHUTi if technical difficulties continued with a survey item on a 5-point scale, If technical difficulties were to continue or return, how likely would you be to continue to use SHUTi? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Evaluation and Utility Questionnaire: Participants Response to Internet as a Delivery Method for Insomnia Intervention | Participants expressed their feedback regarding delivering insomnia intervention using the internet with a survey item on a 5-point scale, How good of a method was the Internet for providing this information? with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to SHUTi Helpfulness | Participants expressed how helpful SHUTi was with a survey item on a 5-point scale, SHUTi was helpful with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Increase in Insomnia Knowledge | Participants expressed how their insomnia knowledge increased with a survey item on a 5-point scale, My knowledge about insomnia increased with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Quality of Life Improvement | Participants expressed any quality of life improvement as a result of SHUTi with a survey item on a 5-point scale, SHUTi improved my overall quality of life with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Mood Improvement | Participants expressed any mood improvement as a result of SHUTi with a survey item on a 5-point scale, SHUTi helped improve my overall mood with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Physical Activity Improvement | Participants expressed any physical activity improvement (e.g. exercise or sports activities) as a result of SHUTi with a survey item on a 5-point scale, SHUTi helped improve my level of physical activities, such as exercise regimen or sports activities with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Ability to Manage Insomnia | Participants expressed any increased effectiveness in the ability to manage insomnia as a result of SHUTi with a survey item on a 5-point scale, SHUTi helped me feel more sure of my ability to manage my insomnia with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Improvement in Difficulties Falling Asleep | Participants expressed any improvement in difficulty falling asleep as a result of SHUTi with a survey item on a 5-point scale, SHUTi helped improve my difficulties with falling asleep with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Improvement in Waking up in the Middle of the Night | Participants expressed any improvement in waking up in the middle of the night as a result of SHUTi with a survey item on a 5-point scale, SHUTi helped improve my difficulties with waking up in the middle of the night with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Improvement in Difficulties Waking up Too Early | Participants expressed any improvement in difficulties waking up too early as a result of SHUTi with a survey item on a 5-point scale, SHUTi helped improve my difficulties with waking up too early with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Improvement in Sleep Quality | Participants expressed any improvement in sleep quality as a result of SHUTi with a survey item on a 5-point scale, SHUTi helped improve my sleep quality with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Impact and Effectiveness Questionnaire: Participants Response to Improvement in Daytime Functioning | Participants expressed any improvement in daytime functioning as a result of SHUTi with a survey item on a 5-point scale, SHUTi helped improve aspects of my daytime functioning like alertness, performance, work attendance, etc. with '0= not at all' to '4=very' | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Tablet as a Primary Device Used to Access SHUTi | Participants responded to using tablet as the primary device to access SHUTi with a survey item, Did you primarily use the tablet to access SHUTi? with a yes or no response | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Working Internet Connection | Participants responded to internet connection problems with a survey item with four options, My internet connection did not work with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Connection Problem to SHUTi | Participants responded to SHUTi connection problems with a survey item with four options, My internet connection worked, but I could not get connected to SHUTi with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Slow Internet Connection | Participants responded to slow internet connection with a survey item with four options, My internet connection was too slow; SHUTi seemed to 'hang' with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Problems With Device | Participants responded to device problems with a survey item with four options, My device wasn't working or was having problems with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Forgetting to Access SHUTi | Participants responded to forgetting to access SHUTi with a survey item with four options, I just forgot to go to SHUTi with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Not Wanting to Access SHUTi | Participants responded to not wanting to access SHUTi with a survey item with four options, I didn't want to go to SHUTi with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Personal Issues Interfering With SHUTi Use | Participants responded to personal issues interfering with SHUTi with a survey item with four options, Personal issues stopped me from using SHUTi with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Work Issues Interfering With SHUTi Use | Participants responded to work issues interfering with SHUTi with a survey item with four options, Work issues stopped me from using SHUTi with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Difficulty Navigating SHUTi | Participants responded to difficulty navigating SHUTi with a survey item with four options, SHUTi was too hard to navigate with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Difficulty Understanding SHUTi Content | Participants responded to difficulty understanding SHUTi content with a survey item with four options, The SHUTi material was too difficult to understand with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to SHUTi Not Being Useful | Participants responded to SHUTi not being useful with a survey item with four options, The SHUTi program did not seem very useful with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to SHUTi Program Being Too 'Wordy' | Participants responded to SHUTi program being too wordy with a survey item with four options, The SHUTi program had too many words with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Screen Being Too Hard to Read | Participants responded to screen being hard to read with a survey item with four options, The screen has hard to read (e.g. words were too small) with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Too Much to do in SHUTi | Participants responded to having too much to do in SHUTi with a survey item with four options, The daily requirements were too much for me to do with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Diaries Taking Too Long to Complete | Participants responded to diaries took too long with a survey item with four options, The diaries took too long to complete with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to SHUTi Helping With Insomnia | Participants responded to SHUTi helping with insomnia with a survey item with four options, I didn't think SHUTi was really going to help with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Too Many Sleep Rules | Participants responded to too many sleep rules with SHUTi with a survey item with four options, There were too many sleep rules to follow with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Spouse/Significant Other/Roommate Having Issues With Participant Using SHUTi | Participants responded to spouse/significant other/roommate having issues with participants using SHUTi with a survey item with four options, My spouse/significant other/roommate did not like me using SHUTi or following the sleep rules with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Difficulty With Sleep Restriction Instructions | Participants responded to difficulty with sleep restriction with a survey item with four options, I could not stick to the sleep restriction instructions with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Who Responded to Sleep Efficiency Not Improving | Participants responded to sleep efficiency not improving with a single categorical survey statement, My sleep efficiency was not improving on a 4-point Likert scale | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Too Much Homework | Participants responded to too much homework with SHUTi with a survey item with four options, There was too much homework with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Internet Intervention Adherence Questionnaire: Participants Response to Homework Difficulty | Participants responded to homework being too difficult with a survey item with four options, The homework was too difficult with 0 = Not a problem, 1 = A little problem 2 = A major problem, & N/A (Not applicable) | 9-11 Weeks post SHUTi initiation | 
| Average Login Counts | SHUTi system generated report of each participant's login counts while they had access to the web based SHUTi program 6-7 months after discharge from inpatient admission | 6-7 months post discharge from inpatient admission for this study | 
| Mean Diary Completion Counts | SHUTi system generated report of each participant's number of completed diaries while they had access to the web based SHUTi program 6-7 months after discharge from inpatient admission | 6-7 months post discharge from inpatient admission for this study | 
| Average Number of Sessions Completed | SHUTi system generated report of each participant's number of completed sessions during the 9-11 week period after starting the first SHUTi session | 9-11 Weeks post SHUTi initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Alcohol Use Disorder, Insomnia, CBTI, Internet CBTI