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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04962087
• Other study ID #: 1026706
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: March 2024
• Source: IWK Health Centre
• Contact: Jaisheen Reen
• Phone: 1-877-341-8309
• Email: TeamHealthEnSuite[@]iwk.nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: July 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Experimental: Health enSuite Insomnia
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.
• Experimental: Health enSuite Insomnia - Deprescribing
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

References & Publications (38)

Antony MM, Bieling PJ, Cox BJ, Enns MW, Swinson RP. Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychol Assess 1998;10(2):176.

Attkisson CC, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In: Maruish ME, editor. The use of psychological testing for treatment planning and outcomes assessment: Instruments for adults Mahwah, NJ, US: Lawrence Erlbaum Associates Publishers; 2004. p. 799-799-811.

Baillargeon L, Landreville P, Verreault R, Beauchemin JP, Gregoire JP, Morin CM. Discontinuation of benzodiazepines among older insomniac adults treated with cognitive-behavioural therapy combined with gradual tapering: a randomized trial. CMAJ. 2003 Nov 11;169(10):1015-20. — View Citation

Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. — View Citation

Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642. — View Citation

Chaput JP, Yau J, Rao DP, Morin CM. Prevalence of insomnia for Canadians aged 6 to 79. Health Rep. 2018 Dec 19;29(12):16-20. — View Citation

Cheung JMY, Jarrin DC, Ballot O, Bharwani AA, Morin CM. A systematic review of cognitive behavioral therapy for insomnia implemented in primary care and community settings. Sleep Med Rev. 2019 Apr;44:23-36. doi: 10.1016/j.smrv.2018.11.001. Epub 2018 Nov 23. — View Citation

Farrell B, Tsang C, Raman-Wilms L, Irving H, Conklin J, Pottie K. What are priorities for deprescribing for elderly patients? Capturing the voice of practitioners: a modified delphi process. PLoS One. 2015 Apr 7;10(4):e0122246. doi: 10.1371/journal.pone.0122246. eCollection 2015. — View Citation

Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005 Nov 19;331(7526):1169. doi: 10.1136/bmj.38623.768588.47. Epub 2005 Nov 11. — View Citation

Gloster AT, Rhoades HM, Novy D, Klotsche J, Senior A, Kunik M, Wilson N, Stanley MA. Psychometric properties of the Depression Anxiety and Stress Scale-21 in older primary care patients. J Affect Disord. 2008 Oct;110(3):248-59. doi: 10.1016/j.jad.2008.01.023. Epub 2008 Mar 4. — View Citation

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. — View Citation

Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657. — View Citation

Holbrook AM, Crowther R, Lotter A, Cheng C, King D. Meta-analysis of benzodiazepine use in the treatment of insomnia. CMAJ. 2000 Jan 25;162(2):225-33. — View Citation

Koffel E, Bramoweth AD, Ulmer CS. Increasing access to and utilization of cognitive behavioral therapy for insomnia (CBT-I): a narrative review. J Gen Intern Med. 2018 Jun;33(6):955-962. doi: 10.1007/s11606-018-4390-1. Epub 2018 Apr 4. — View Citation

Lee JY, Farrell B, Holbrook AM. Deprescribing benzodiazepine receptor agonists taken for insomnia: a review and key messages from practice guidelines. Pol Arch Intern Med. 2019 Jan 31;129(1):43-49. doi: 10.20452/pamw.4391. Epub 2018 Dec 13. Erratum In: Pol Arch Intern Med. 2019 Feb 28;129(2):145. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. — View Citation

Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2). doi: 10.7326/P16-9016. Epub 2016 May 3. No abstract available. — View Citation

Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601. — View Citation

Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. doi: 10.1016/S0140-6736(11)60750-2. Epub 2012 Jan 20. Erratum In: Lancet. 2012 Apr 21;379(9825):1488. — View Citation

Morin CM, Blais F, Savard J. Are changes in beliefs and attitudes about sleep related to sleep improvements in the treatment of insomnia? Behav Res Ther. 2002 Jul;40(7):741-52. doi: 10.1016/s0005-7967(01)00055-9. — View Citation

Morin CM, LeBlanc M, Belanger L, Ivers H, Merette C, Savard J. Prevalence of insomnia and its treatment in Canada. Can J Psychiatry. 2011 Sep;56(9):540-8. doi: 10.1177/070674371105600905. — View Citation

Morin CM, Vallieres A, Guay B, Ivers H, Savard J, Merette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682. — View Citation

Morin CM. Measuring outcomes in randomized clinical trials of insomnia treatments. Sleep Med Rev. 2003 Jun;7(3):263-79. doi: 10.1053/smrv.2002.0274. — View Citation

Ng BJ, Le Couteur DG, Hilmer SN. Deprescribing Benzodiazepines in Older Patients: Impact of Interventions Targeting Physicians, Pharmacists, and Patients. Drugs Aging. 2018 Jun;35(6):493-521. doi: 10.1007/s40266-018-0544-4. — View Citation

Olivier J, May WL, Bell ML. Relative effect sizes for measures of risk. Communications in Statistics-Theory and Methods 2017;46(14):6774-6781.

Pollmann AS, Murphy AL, Bergman JC, Gardner DM. Deprescribing benzodiazepines and Z-drugs in community-dwelling adults: a scoping review. BMC Pharmacol Toxicol. 2015 Jul 4;16:19. doi: 10.1186/s40360-015-0019-8. — View Citation

Pottie K, Thompson W, Davies S, Grenier J, Sadowski CA, Welch V, Holbrook A, Boyd C, Swenson R, Ma A, Farrell B. Deprescribing benzodiazepine receptor agonists: Evidence-based clinical practice guideline. Can Fam Physician. 2018 May;64(5):339-351. — View Citation

Prochaska JO. Transtheoretical model of behavior change. Encyclopedia of behavioral medicine: Springer; 2013. p. 1997-2000.

Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249. — View Citation

Rogojanski J, Carney CE, Monson CM. Interpersonal factors in insomnia: a model for integrating bed partners into cognitive behavioral therapy for insomnia. Sleep Med Rev. 2013 Feb;17(1):55-64. doi: 10.1016/j.smrv.2012.02.003. Epub 2012 May 18. — View Citation

Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504. — View Citation

Thorndike FP, Ritterband LM, Saylor DK, Magee JC, Gonder-Frederick LA, Morin CM. Validation of the insomnia severity index as a web-based measure. Behav Sleep Med. 2011;9(4):216-23. doi: 10.1080/15402002.2011.606766. — View Citation

Thorndike FP, Saylor DK, Bailey ET, Gonder-Frederick L, Morin CM, Ritterband LM. Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. E J Appl Psychol. 2008;4(2):32-42. doi: 10.7790/ejap.v4i2.133. — View Citation

Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841. — View Citation

van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9. — View Citation

Voshaar RC, Gorgels WJ, Mol AJ, van Balkom AJ, van de Lisdonk EH, Breteler MH, van den Hoogen HJ, Zitman FG. Tapering off long-term benzodiazepine use with or without group cognitive-behavioural therapy: three-condition, randomised controlled trial. Br J Psychiatry. 2003 Jun;182:498-504. doi: 10.1192/bjp.182.6.498. — View Citation

Ye YY, Zhang YF, Chen J, Liu J, Li XJ, Liu YZ, Lang Y, Lin L, Yang XJ, Jiang XJ. Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-i) Improves Comorbid Anxiety and Depression-A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Nov 18;10(11):e0142258. doi: 10.1371/journal.pone.0142258. eCollection 2015. — View Citation

Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24. — View Citation

* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Trial 2 - Change in insomnia symptoms at 8 and 20 weeks	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
Primary	Trial 2 - Change in use of BZRA medication at 8 and 20 weeks	The primary outcome measure for Trial 2 is change 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	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
Secondary	Trial 2 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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