Investigating the Effectiveness of E-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia
ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Nazanin Alavi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
e-CBTi
BehavioralSee arm/group description
Trazodone
DrugSee arm/group edescription
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PharmacotherapyActive comparator 1 intervention
Group B: e-CBTiExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Baseline (week 0), mid-point (week 3-4), post-treatment (week 7)Secondary outcomes
1
Sleep Diary - Change in Sleep Quality
Change in Sleep Quality - Scale of 1-5, 1 being very poor, 5 being very good
Time frame
Week 0, 1, 2, 3, 4, 5, 6, 72
Sleep Diary - Change in Sleep quality
Bedtime, time of falling asleep, nighttime awakenings, time of waking up, time getting out of bed
Time frame
Week 0, 1, 2, 3, 4, 5, 6, 73
Behavioural Interactions- Change in Engagement
Number of log-ins per day, amount of time spent on each module
Time frame
Week 0, 1, 2, 3, 4, 5, 6, 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Nazanin Alavi
Lead sponsor
Queen's University
Sponsor institution
Online PsychoTherapy Clinic
Collaborator
Source ClinicalTrials.gov