Recruiting

Digital CBT

Sponsor:

University Health Network, Toronto

Code:

NCT05816304

Conditions

Insomnia

Post Traumatic Stress Disorder

Anxiety Disorders

Depression

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)

Study Details

Brief summary:

The COVID-19 pandemic has resulted in increased workload and concerns about personal and family safety for frontline healthcare workers (HCWs), which can lead to decreased well-being and worsening mental health. Sleep disruption is particularly prevalent among HCWs providing frontline COVID-19 care. It can have direct consequences on their cognitive and emotional functioning, as well as on patient safety. Cognitive Behavioral Therapy for insomnia (CBTi) is a first-line treatment for insomnia. It has been shown to improve sleep health and wellbeing in the general population. However, there are significant barriers to delivering CBTi to frontline HCWs, including limited availability of trained sleep therapists and high costs. To address this, a Canada-wide randomized controlled trial is developed to determine the effectiveness of a digital CBTi program on the sleep health, mental health, wellness, and overall quality of life of frontline HCWs caring for COVID-19 patients. This study may provide an easily accessible and scalable sleep health intervention that can be included as part of a national and global response to the COVID-19 pandemic.

Conditions

Insomnia

Post Traumatic Stress Disorder

Anxiety Disorders

Depression

Study ID

NCT05816304

Start date

Jun 16, 2023

Status verified date

Aug, 2024

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Health care workers with probable insomnia disorder, as indicated by a score of 16 or lower on the Sleep Condition Indicator (SCI),
  • Self-identify as being involved in frontline management of patients;
  • Access to a mobile phone or a computer with Internet access.

Exclusion Criteria:

  • Participants requiring urgent CBT treatment as per their health care provider,
  • Participants received CBT in the past 3 months
  • Participants participating in other psychological treatments and/or drug trials during the study;
  • Self-reported additional sleep related disorders: sleep apnea or restless legs syndrome;
  • Significant other significant medical or psychiatric conditions e.g. life threatening (e.g. cancer), neurological conditions (e.g. epilepsy); severe depression , active suicide intent.

Study Design

Enrollment

366 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention arm

Digital CBTi will be offered using the SleepioTM website and supporting Sleepio™ app (Big Health Ltd., London, UK) via 6 sessions training program (spanning 6 to 12 weeks), lasting an average of 20 minutes each, unlocked weekly. The participant will receive the Sleepio intervention as soon as they become assigned.

no intervention: Attention Control arm

Participants in the control group will have access to online the sleep diary and sleep education material for 12 weeks, without the CBTi intervention by the Sleepio™ app (Big Health Ltd., London, UK). They will start the digital cognitive behavioral therapy for insomnia (dCBTi) intervention 12 weeks after the initial enrollment.

Interventions

Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)

Digital CBTi is a computer-based cognitive behavioral therapy that provides strategies to improve sleep and daytime function (concentration, productivity) and decreases symptoms of sleep-related attributions, night-time thought content in individuals with insomnia. It is easily accessible with any internet-connected device, eg, computer, tabs, and smartphones.

Primary outcome measure

  • Assessing changes in the nature and severity of insomnia: [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Mandeep Singh, MBBS, FRCPC

416-603-5118mandeep.singh@uhn.ca

Abdel Basit Al Hawwari, MSN, RN

4166035800abdelbasit.alhawwari@uhn.ca

Locations

Toronto Western Hospital - UHN

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Mandeep Singh, MBBS, FRCPC

416-603-5118mandeep.singh@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 11, 2024

Last verified

Aug, 2024

Keywords

  • Insomnia,
  • sleep health,
  • Cognitive Behavioral Therapy
  • Digital Cognitive Behavioral Therapy
  • Health Care Workers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-12-11.