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 range18 Years

SexALL

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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

What they're measuring

Mood

Timeframe: 28 days

Trial details

NCT IDNCT02679768

SponsorUniversity Hospital Bispebjerg and Frederiksberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-22