Clinical trial NCT04962087: Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
Official title: Randomized Controlled Trials to Evaluate Health enSuite Insomnia: an App Based Treatment for Adult Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Deprescribing
Cognitive Behavioural Therapy
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Trial 1 - Change in insomnia severity at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 2 - Change in insomnia symptoms at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 2 - Change in use of BZRA medication at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
Secondary outcomes:
measure: Trial 1 - Change in total sleep time at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 2 Change in total sleep time at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 1 - Change in frequency and duration of nocturnal awakening at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 2 - Change in frequency and duration of nocturnal awakening at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 1 - Change in sleep onset latency at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 2 - Change in sleep onset latency at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 1 - Change in daily sleep efficiency at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 2 - Change in daily sleep efficiency at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 1 - Change in psychological distress at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
measure: Trial 2 - Change in psychological distress at 8 and 20 weeks
timeFrame: Baseline assessment, 8 weeks post-randomization, 20 weeks post-randomization
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Centre for Research in Family Health, IWK Health
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Patrick McGrath
role: PRINCIPAL_INVESTIGATOR
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