Self-help Smartphone-delivered Cognitive Behavioral Therapy for Insomnia in People With Depressio… (NCT04228146) | Clinical Trial Compass
UnknownNot Applicable
Self-help Smartphone-delivered Cognitive Behavioral Therapy for Insomnia in People With Depression and Insomnia
China285 participantsStarted 2019-03-19
Plain-language summary
This randomized controlled trial aims to examine the effectiveness of a self-help smartphone-delivered cognitive behavioral therapy for insomnia, compared to a waitlist control, in treating people with major depression and insomnia in Hong Kong.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Stage 1 Screening (Online Survey) Inclusion Criteria:
* Hong Kong residents
* age ≥ 18 years
* predominant complaint of difficulty initiating or maintaining sleep or early morning awakening or non-restorative sleep with associated distress or impairment in social, occupational and other important areas of functioning for at least three nights per week for at least three months
* Insomnia Severity Index score ≥ 8
* Patient Health Questionnaire (PHQ-9) score ≥ 10
* being able to read Chinese and type Chinese or English
* have a smartphone device (iOS or Android operating system) with Internet access
* have a regular email address
* willing to give informed consent and comply with the trial protocol
Stage 1 Screening (Online Survey) Exclusion Criteria:
* Beck Depression Inventory II (BDI-II) suicidal ideation score ≥ 2
* receiving concurrent psychological treatment at least once per month
* former proACT-S pilot clinical trial participants
* currently taking prescribed psychiatric drugs such as antidepressants, tranquilizers, sleeping pills regularly
* carrying a diagnosis of psychosis or schizophrenia
* participating in any other academic studies or clinical trials related to insomnia and/or depression
Stage 2 Screening (Telephone Diagnostic Interview) Inclusion Criteria
* difficulty initiating sleep, maintaining sleep, or early-morning awakening with inability to return to sleep at least once in the past two weeks
* International Statistical Classification of Diseases and…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes over the measurement points in Center for Epidemiologic Studies Depression Scale
Timeframe: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
2
Changes over the measurement points in Insomnia Severity Index
Timeframe: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up
3
Changes over the measurement points in Pittsburgh Sleep Quality Index
Timeframe: Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up