Recovery-by-eHealth: A Complex Intervention Aiding Recovery in Patients With Depression Discharged From a Psychiatric Outpatient Clinic - a 12 Months Randomized Controlled Clinical Trial

Background: During the last seven years, our research group has collected considerable experience with conducting and contributing studies aiming to prevent relapse of depression and readmissions using a complex intervention with electronic self-monitoring in combination with feedback from health investigators. In our first study ("SAFE-I: Electronic self-monitoring with clinical feedback in depression, a feasibility study"), we used a self-monitoring system to investigate the connection between sleep and depression after discharge from a psychiatric inpatient ward to the Intensive Affective Outpatient Clinic (IAOC) in combination with weekly feedback from investigators by telephone. Patients evaluated the electronic system with a high usability score, and there was a high data entry rate. Patients gradually delayed their sleep after discharge from the psychiatric inpatient ward, and this delay of sleep was found to be related to a worsening of depression. Subsequently, we designed a Randomized Controlled Trial (RCT) ("SAFE II: Can electronic self-monitoring with closed loop feedback focusing on regulation of the sleep-wake cycle reduce relapse of depression after discharge from a psychiatric ward") that included patients before discharge from a psychiatric inpatient ward and in the early faces of their stay at IAOC, and followed them for four weeks. Patients were randomized to one group using electronic self-monitoring with feedback from health investigators focusing on self-reported data, and another group that in addition to the electronic self-monitoring was guided to attain signals to the circadian clock to stabilize the, sleep-wake cycle (diet, daylight exposure, sleep, and behavioral motivation towards social function and physical activity). In all, 103 patients were included in the trial (last patient visit 22-12-2020). From the qualitative data in this study, we found that patients expressed a feeling of support and safety by participating in the study. They especially felt that the electronic self-monitoring with continuous feedback from investigators provided them with an important reflection on their activity and mental health. The depression severity decreased significantly in both groups, comparable to what was found in the SAFE-I study. Readmission rates were low in both groups (7.8 %). However, the study lacked an independent evaluation of the implementation of the health interventions, i.e. process evaluation. Users were not involved in the study's design. The SAFE-studies found that feedback from investigators is deemed critical for a positive outcome, a finding supported by reviews of studies using electronic self-monitoring in combination with feedback from investigators for patients with depression. This proposed trial comprise further development based on experiences from these studies.

Objective: Recovery-by-eHealth investigates whether a complex intervention can aid recovery and prevent relapse in depression and readmissions in patients who have previously been treated for depression at a psychiatric outpatient clinic.

Design: A randomized controlled trial. Participants will be 1:1 randomized into either an recovery-group or a control-group.

Intervention: Participants allocated to the recovery-group will make daily self-monitoring about their physical, mental and social health in an app for one week in total each month. At the end of these weekly periods a health investigator will phone the patients to provide feedback. Additional calls are allowed when needed. Patients allocated to the control-group will follow their usual treatment at their general practitioner and/or private practice psychiatrist.

The project will be an intersectoral collaboration between 1) Mental Health Centre Copenhagen Rigshospitalet, Intensive Affective Outpatient Clinic 2) Centre for Research and Education in General Practice, University of Copenhagen 2) Centre for Social Medicine at Frederiksberg Hospital, 3) Competence Centre for Rehabilitation and Recovery, Mental Health Centre Ballerup, and 5) Private Practicing Psychiatrists.