Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia

Study Overview
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Brief Summary
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This project consists of two independent but related randomized controlled trials. Trial 1 will focus on people who are not currently prescribed BZRA medications. Trial 2 will focus on people who have been taking BZRA medications and are initiating gradual tapering of these medications as recommended and supervised by their primary health care provider.

Detailed Description
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This study aims to develop and test the effectiveness of cognitive behavioural program for insomnia (Health enSuite Insomnia) delivered through a web-browser or smartphone app, thereby making the treatment more widely accessible. Health enSuite apps will be available for recommendation by primary care providers at the point of care. Trial 1 - Cognitive behavioural therapy (CBT) is recommended as the first line of treatment for insomnia, but this resource intensive therapy is not always readily available to many patients. Therefore, there is a need to improve the availability and accessibility of cognitive behavioural therapy for insomnia. Trial 2- Pharmacological treatments such as benzodiazepines or benzodiazepines receptors agonists (BZRA) are frequently prescribed for insomnia. Although these medications are useful for relieving insomnia symptoms in the short-term, their long-term use is associated with reduced efficacy, persistent side effects, and increased risk of physical and psychological dependence. However, very few tools exist to facilitate de-prescribing sleep medications. Therefore, there is a need to investigate how to increase successful de-prescribing of pharmacological treatments. The effectiveness of Health enSuite Insomnia will be evaluated both in terms of improving insomnia symptoms (Trial 1 and 2) and in systematically reducing the use of medications prescribed for insomnia (Trial 2). Trial 1 - For people who are not taking medications for insomnia, the primary research question is whether Health enSuite insomnia will lead to greater improvements in insomnia symptoms as measured by the Insomnia Severity Index, than standard psycho-education for insomnia. Health enSuite Insomnia is hypothesized to result in greater improvements in insomnia symptoms compared to psychoeducation alone. Trial 2 - For people who have been taking BZRA medications for insomnia and are initiating a gradual medication tapering schedule, the primary research question is whether Health enSuite Insomnia will lead to more successful deprescribing (greater reductions in medication intake) than standard psycho-education for insomnia. Health enSuite Insomnia is hypothesized to result in greater adherence to a gradual medication reduction schedule and fewer insomnia symptoms over time. Secondary hypotheses for both Trial 1 and Trial 2 are that Health enSuite Insomnia will result in greater improvement in specific daily sleep parameters (i.e., sleep efficiency, sleep quality, sleep onset latency, number of awakenings, total sleep time) and greater improvements in psychological well-being in both types of participants (those not taking medications and those initiating deprescribing). This project consists of two independent but related randomized controlled trials. Trial 1 will focus on people who are not currently prescribed BZRA medications. Trial 2 will focus on people who have been taking BZRA medications and are initiating gradual tapering of these medications as recommended and supervised by their primary health care provider. Both have 2 parallel arms (Health enSuite Insomnia or psychoeducation control). Eligible participants will be randomized to either treatment group in a 1:1 ratio using a stratified randomization procedure with permuted blocks. Primary and secondary outcome measures will be completed at baseline, 8 weeks (post-intervention) and 20 weeks (follow-up). Health enSuite Insomnia is based on existing treatment manuals for effective cognitive behavioural treatment of insomnia. The content was adapted for delivery via web-based and smartphone apps. Health enSuite Insomnia consists of 6 CBT modules completed at least 1 week apart. These modules cover psychoeducation, sleep restriction, sleep hygiene, relaxation therapy, cognitive therapy, and relapse prevention. Those in the psycho-education only control will receive a version of the app that contains static psycho-educational content only similar to what is commonly provided in primary care.

Official Title
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Randomized Controlled Trials to Evaluate Health enSuite Insomnia: an App Based Treatment for Adult Chronic Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Experimental: Health enSuite Insomnia
* Behavioral: Experimental: Health enSuite Insomnia - Deprescribing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for Trial 1 (no medication de-prescribing), participants will have to satisfy the following criteria: Age 18 years or older Have one or more insomnia symptoms at least 3 times per week for at least 3 months Not currently prescribed medications for insomnia. To be eligible for Trial 2 (includes medication de-prescribing), participants will have to satisfy the following criteria: Age 18 years or older Have one or more insomnia symptoms at least 3 times per week for at least 3 months Currently prescribed 1 or 2 BZRA or benzodiazepine medications for insomnia Exclusion Criteria: If the participant's responses suggest any of the following, they will not be eligible for either trial: Do not have a device with internet access (e.g., smartphone, tablet, or computer). Regularly working shifts overnight Parent of an infant (less than 1 year old) Currently pregnant or trying to become pregnant Participant is taking benzodiazepines or non-benzodiazepine Z-drugs for conditions other than insomnia. [assessed during physician referral] Participant is taking more than 2 BZRA medications. [assessed during physician referral] Women who are pregnant will be excluded. Pregnant women tend to experience sleep disruption due to symptoms of pregnancy (e.g., heartburn, nausea or vomiting, frequent awakenings for urination, back pain). This program is not designed to help this sub-group of people. Parents of infant children will also be excluded due to the possibility of frequent sleep disturbances related to caregiving responsibilities.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This project consists of two independent but related randomized controlled trials. Trial 1 will focus on people who are not currently prescribed BZRA medications. Trial 2 will focus on people who have been taking BZRA medications and are initiating gradual tapering of these medications as recommended and supervised by their primary health care provider. Both have 2 parallel arms (Health enSuite Insomnia or psychoeducation control). Eligible participants will be randomized to either treatment group in a 1:1 ratio using a gender and age stratified randomization procedure with permuted blocks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health enSuite Insomnia<br>Health enSuite: Insomnia has been designed based on established cognitive behavioural treatments for insomnia and adapted to fit an automated interactive platform available via an internet enabled device. The program is divided into a series of treatment modules or levels that will be delivered over the course of 6-8 weeks. The content of these 6 levels includes the following components, a sleep diary, sleep restriction clock, sleep hygiene, relaxation techniques, sleep related thoughts and beliefs, and involving a support person. | Behavioral: Experimental: Health enSuite Insomnia<br>* Health enSuite: Insomnia has been designed based on established cognitive behavioural treatments for insomnia and adapted to fit an automated interactive platform available via an internet enabled device. The program is divided into a series of treatment modules or levels that will be delivered over the course of 6-8 weeks. The content of these 6 levels includes the following components, a sleep diary, sleep restriction clock, sleep hygiene, relaxation techniques, sleep related thoughts and beliefs, and involving a support person.<br>|
| No Intervention: Psychoeducation Control<br>Participants allocated to the Control group will receive a version of the Health enSuite Insomnia app that contains a static psychoeducation module. It will contain information related to insomnia and its treatment. Topics covered will include a brief description of cognitive behavioural therapy for insomnia. | |
| Experimental: Health enSuite Insomnia - Deprescribing<br>All participants in Trial 2 will be initiating a gradual medication tapering schedule recommended to them by their physician. The module physicians use to refer their patients to the study includes a section where they fill out a brief drug history for sleep medications. This information is then used to generate a tapering schedule that the health care provider will review with their patient. Health care providers are responsible for providing appropriate medication counselling and follow-up care to supervise deprescribing. This study does not place any restriction on the usual care participants will receive. | Behavioral: Experimental: Health enSuite Insomnia - Deprescribing<br>* All participants in Trial 2 will be initiating a gradual medication tapering schedule recommended to them by their physician. The module physicians use to refer their patients to the study includes a section where they fill out a brief drug history for sleep medications. This information is then used to generate a tapering schedule that the health care provider will review with their patient. Health care providers are responsible for providing appropriate medication counselling and follow-up care to supervise deprescribing. This study does not place any restriction on the usual care participants will receive.<br>|
| No Intervention: Psychoeducation Control - Deprescribing<br>Participants allocated to the Control group will receive a version of the Health enSuite Insomnia app that contains a static psychoeducation module. It will contain information related to insomnia and its treatment. Topics covered will include a brief description of cognitive behavioural therapy for insomnia and information about the benefits of medication de-prescribing for those in Trial 2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial 1 - Change in insomnia severity at 8 and 20 weeks | The Insomnia Severity Index (ISI) is a brief 7-item measure that assesses the perceived severity of insomnia, and the degree of dissatisfaction with sleep, interference with daily functioning, noticeability of impairment, and distress caused by the sleep disturbances. It was designed to capture both nighttime and daytime components of insomnia and to reflect diagnostic criteria for primary insomnia. The ISI is also responsive in treatment studies for insomnia and has been validated for web-based delivery. The ISI is included in the baseline assessment questionnaire and the follow-up assessment questionnaire. Each of the 7 items has a minimum value of 0 and a maximum value of 4, with total scores on the scale ranging from 0-28, with higher scores indicating severe insomnia. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 2 - Change in use of BZRA medication at 8 and 20 weeks | The primary outcome measure for Trial 2 is change in in use of BZRA medications for insomnia. The rate of medication tapering is recommended based on how long the patient has been prescribed the medication. Those who have been taking the medication for a short period of time can be deprescribed more rapidly than long-term users. Change in medication will be quantified relative to the expected dose at week 8 and week 20 based on the medication tapering schedule the participant has initiated. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial 1 - Change in total sleep time at 8 and 20 weeks | Secondary outcome measures for trial one include change in total sleep time, measured in hours and minutes, using daily sleep diaries. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 1 - Change in frequency and duration of nocturnal awakening at 8 and 20 weeks | Secondary outcome measures for trial one include change in frequency and duration of nocturnal awakenings, measured in hours and minutes, using daily sleep diaries. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 1 - Change in sleep onset latency at 8 and 20 weeks | Secondary outcome measures for trial one include change in sleep onset latency, measured in hours and minutes, using daily sleep diaries. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 1 - Change in daily sleep efficiency at 8 and 20 weeks | Secondary outcome measures for trial one include change in sleep efficiency (time spent awake in bed), measured in hours and minutes, using daily sleep diaries. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 1 - Change in psychological distress at 8 and 20 weeks | Secondary outcome measures for trial one include change in psychological distress, measured using the Depression, Anxiety and Stress Scales short form (DASS-21). Each of the 21 items has a minimum value of 0 and a maximum value of 3. Higher scores indicate severe psychological distress. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 2 - Change in insomnia symptoms at 8 and 20 weeks | Secondary outcome measures for Trial 2 are change in insomnia symptoms measured using the Insomnia Severity Index (ISI). The Insomnia Severity Index (ISI) is a brief 7-item measure that assesses the perceived severity of insomnia, and the degree of dissatisfaction with sleep, interference with daily functioning, noticeability of impairment, and distress caused by the sleep disturbances. It was designed to capture both nighttime and daytime components of insomnia and to reflect diagnostic criteria for primary insomnia. The ISI is also responsive in treatment studies for insomnia and has been validated for web-based delivery. The ISI is included in the baseline assessment questionnaire and the follow-up assessment questionnaire. Each of the 7 items has a minimum value of 0 and a maximum value of 4. with total scores on the scale ranging from 0-28, with higher scores indicating severe insomnia. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 2 - Change in Change in total sleep time at 8 and 20 weeks | Secondary outcome measures for Trial 2 include change in total sleep time, measured in hours and minutes, using daily sleep diaries. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 2 - Change in frequency and duration of nocturnal awakening at 8 and 20 weeks | Secondary outcome measures for Trial 2 include change in frequency and duration of nocturnal awakenings, measured in hours and minutes, using daily sleep diaries. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 2 - Change in sleep onset latency at 8 and 20 weeks | Secondary outcome measures for Trial 2 include change in sleep onset latency, measured in hours and minutes, using daily sleep diaries. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 2 - Change in daily sleep efficiency at 8 and 20 weeks | Secondary outcome measures for Trial 2 include include change in sleep efficiency (time spent awake in bed), measured in hours and minutes, using daily sleep diaries. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 
| Trial 2 - Change in psychological distress at 8 and 20 weeks | Secondary outcome measures for Trial 2 include change in psychological distress, measured using the Depression, Anxiety and Stress Scales short form (DASS-21). Each of the 21 items has a minimum value of 0 and a maximum value of 3. with total scores on the scale ranging from 0-63, with higher scores indicate severe psychological distress. | Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Deprescribing, Cognitive Behavioural Therapy