Electronic Self-monitoring on Regulation of the Sleep-wake Cycle to Reduce Relapse of Depression … (NCT02679768) | Clinical Trial Compass
CompletedNot Applicable
Electronic Self-monitoring on Regulation of the Sleep-wake Cycle to Reduce Relapse of Depression After Discharge
Denmark103 participantsStarted 2016-09-01
Plain-language summary
Very little is known of depressed patients' mental state after being discharged from inpatient wards where they are provided with a sheltered environment with stable sleep wake cycle, regular meals, and regular physical and social activities. Our previous usability study, SAFE I, showed that electronic self-monitoring was a useful tool to gain insight into patients' condition in the weeks after discharge. Results showed that patients over a four week period had significant day to day variations in self-rated mood and sleeping schedule and that the patients' sleep patterns were delayed with 45 minutes.
In the actual study, SAFE II, we are investigating whether an intervention with a strong focus on the circadian timing of daytime activities, and sleep, coined Circadian Reinforcement Therapy (CRT), can lead to a faster recovery of depression and prevent relapse into depression after discharge.
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:
* Major depression as defined in DSM-5
* Hospitalized at a psychiatric inpatient ward
* Age above 18
Exclusion Criteria:
* Bipolar depression
* Suicidal plans or ideations (score of 2 or more on the HAM-D17 scale) item 3 or if investigator is unsure of level og suicidality
* Dementia or other organic brain damage that might influence ability to use the electronical monitoring system (Daybuilder) and the rules of the study
* Psychotic depression at time of inclusion.
* Abuse of alcohol or other drugs that might influence the ability to comply with study rules
* Patients under any form of coercion
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
Mood
Timeframe: 28 days
Trial details
NCT IDNCT02679768
SponsorUniversity Hospital Bispebjerg and Frederiksberg