Investigating the Effectiveness of E-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia

NCT05125146 | Recruiting

• 1 other identifier: 6032770
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI) - Change in Symptoms (Quantitative)

  Measures insomnia symptom severity; 7 questions; answer range from 0-4, 0 being best, 4 being worst

  Baseline (week 0), mid-point (week 3-4), post-treatment (week 7)

Secondary Outcomes (3)

• Sleep Diary - Change in Sleep Quality

  Week 0, 1, 2, 3, 4, 5, 6, 7

• Sleep Diary - Change in Sleep quality

  Week 0, 1, 2, 3, 4, 5, 6, 7

• Behavioural Interactions- Change in Engagement

  Week 0, 1, 2, 3, 4, 5, 6, 7

Study Arms (2)

Pharmacotherapy

ACTIVE COMPARATOR

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.

Drug: Trazodone

e-CBTi

EXPERIMENTAL

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.

Behavioral: e-CBTi

Interventions

e-CBTi BEHAVIORAL

See arm/group description

Also known as: Electronically-Delivered CBT

e-CBTi

Trazodone DRUG

See arm/group edescription

Also known as: Control

Pharmacotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead
• Online PsychoTherapy Clinic: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L5G2, Canada

RECRUITING

Related Publications (1)

• Zhu Y, Stephenson C, Moghimi E, Jagayat J, Nikjoo N, Kumar A, Shirazi A, Patel C, Omrani M, Alavi N. Investigating the effectiveness of electronically delivered cognitive behavioural therapy (e-CBTi) compared to pharmaceutical interventions in treating insomnia: Protocol for a randomized controlled trial. PLoS One. 2023 May 16;18(5):e0285757. doi: 10.1371/journal.pone.0285757. eCollection 2023.

  PMID: 37192176 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Nazanin Alavi, MD FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazanin Alavi, MD FRCPC

CONTACT

6135443310; nazanin.alavi@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychiatrist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: November 1, 2021
• Primary Completion: May 21, 2025
• Study Completion: December 30, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Findings will be published on an ongoing basis
• Access Criteria: Open-access

Locations

CA (1)