E-aid Sleep-focused TrEatment for Prevention of Major Depression (STEP-MD) (NCT03309527) | Clinical Trial Compass
UnknownNot Applicable
E-aid Sleep-focused TrEatment for Prevention of Major Depression (STEP-MD)
China1,000 participantsStarted 2017-11-01
Plain-language summary
In the past, there were studies on relationship between insomnia and depression, and those studies found that depression can be the result of untreated insomnia. Mostly insomnia precedes depression, and is a marker for recurrence of depression. Research suggests that insomnia may cause depression by changing the emotional response.
In this study, investigators will establish the national online cognitive behavioral therapy for insomnia (e-aid Cognitive Behavioral Therapy for Insomnia, eCBTI ) tools, and online health education on sleep (e-aid Sleep Hygiene Education, eSHE ) tools for controls. Investigators will be testing whether eCBTI can reduce the incidence of depression in patients with sleep disorders, increasing remission rate of depression, and a corresponding reduction in suicidal ideas, compared with eSHE control groups.
Who can participate
Age range
18 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.
Inclusion Criteria:
* the diagnostic criteria for insomnia in accordance with DSM-5
* 18 years or older
* compliant and have a good understanding of research program
* able to fill the online informed consent form
* owns and have a good command on electronic gadgets (e.g., smart phones, tablets, computers, etc.)
Exclusion Criteria:
* clear and unhealed physical, mental and/or sleep disorders requiring acute care
* is taking psychotherapy for insomnia
* shift workers, regular night shift workers, frequent time zone fliers (such as crew members on international flights)
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
occurrence of depression
Timeframe: changes of occurrence of depression from baseline to 2weeks, 5 weeks, 6 months and 12 months.
Trial details
NCT IDNCT03309527
SponsorNanfang Hospital, Southern Medical University