Recruiting

E-CBTi vs. Pharmaceuticals

Sponsor:

Dr. Nazanin Alavi

Code:

NCT05125146

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

e-CBTi

Trazodone

Study Details

Brief summary:

Insomnia is defined as the inability to fall asleep or stay asleep at night and it is one of the most prevalent sleep disorders that can have deleterious impacts on health and this population's quality of life. Currently, both pharmaceutical interventions (trazodone) and cognitive behavioral therapy (CBTi) are widely used to treat patients with insomnia. Although CBTi has been efficacious in many patients, multitude of barriers for receiving treatment such as its limited availability of therapists, high costs and long wait times challenge its ability in sufficiently meeting the population's health needs and demands. To improve the delivery of CBT, electronically delivered CBTi (e-CBTi) has been developed as an accessible and effective alternative intervention for improving sleep outcomes in patients with insomnia. While evidence suggest that e-CBTi is effective when compared to placebos/waitlist control, evidence comparing guided e-CBTi to pharmaceutical interventions is still insufficient and needs further exploration.

Conditions

Insomnia

Study ID

NCT05125146

Start date

Nov 1, 2021

Status verified date

Oct, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

May 21, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 18 years of age at the start of the study
  • Non-organic insomnia
  • Difficulty initiating, and/or maintaining sleep for ≥ 30 minutes and
  • Use of sleep-promoting medication at least three nights per week for at least 3 months
  • Ability to speak and read English
  • Consistent and reliable access to the internet.

Exclusion Criteria:

  • Presence of another untreated sleep disorder
  • Alcohol or substance use disorder
  • Ongoing CBT
  • Non-assessed or untreated clinically significant somatic or mental symptoms or illnesses
  • Other sleep disorders that could explain current insomnia symptoms or interfere with or be worsened by e-CBTi
  • Pregnancy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pharmacotherapy

Trazodone is the treatment of choice for insomnia and participants allocated to the pharmaceutical intervention group will be prescribed trazodone as a regular treatment for the duration of the study. Participants on trazodone will also visit the psychiatrist every month to ensure their wellbeing is protected, the quality of the data is maintained, the conduct of the trial is in compliance with the approved protocol, and other regulatory requirements. Trazodone is the routine practice for insomnia and is covered through most patients' healthcare. However, if the patient does not have coverage for trazodone, they will be provided financial compensation to offset the cost.

experimental: e-CBTi

The e-CBTi modules will involve guiding participants to develop constructive and balanced strategies that would help to handle sleep problems. The e-CBTi program is based on the idea that insomnia is caused by thoughts and behaviours that can be changed. The modules aim to adjust negative thinking so patients can think about and adapt to the events that are happening to them, allowing them to adjust their behaviour and thoughts to be more realistic. Continuing, the modules are designed to help patients with insomnia deal with inaccurate thoughts about sleep and negative sleep behaviours, change their lifestyle practices that negatively affect their sleep, and improve relaxation skills to improve healthy sleep patterns. More specifically, the focus of the program is on addressing and exploring the concept of sleep, sleep habits, sleep hygiene, bedtime worries, negative thoughts, and thought examination.

Interventions

e-CBTi

See arm/group description

Trazodone

See arm/group edescription

Primary outcome measure

  • Insomnia Severity Index (ISI) - Change in Symptoms (Quantitative) [ Time Frame: Baseline (week 0), mid-point (week 3-4), post-treatment (week 7) ]

Central Contacts and Locations

Central contacts

Nazanin Alavi, MD FRCPC

6135443310nazanin.alavi@queensu.ca

Locations

Queen's University

Recruiting

Kingston, Ontario, Canada, K7L5G2

Contacts

Nazanin Alavi, MD FRCPC

6135443310nazanin.alavi@queensu.ca

More Information

Sponsor

Dr. Nazanin Alavi

Last update posted

Oct 18, 2024

Last verified

Oct, 2024

Keywords

  • Insomnia
  • Mental health
  • Psychotherapy
  • Cognitive behavioral therapy
  • Online
  • Internet
  • Mental health care
  • Pharmacotherapy
  • Pharmaceutical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Nazanin Alavi on 2024-10-18.