Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial

BACKGROUND: Patients with major depression exhibit circadian disturbance of sleep and mood, and when these patients are discharged from inpatient wards, this poses a risk for relapse. To improve this transition from inpatient wards to returning home, we developed the Circadian Reinforcement Therapy (CRT) intervention. The CRT focuses on increasing the zeitgeber strength to the circadian clock from social contact, physical activity, diet, daylight exposure and sleep timing.

OBJECTIVE: This study aimed to prevent the worsening of depression after discharge using the CRT to advance and stabilize sleep and mood, supported by an electronic self-monitoring system. The primary outcome was the change in Hamilton depression rating scale (HAM-D17) scores from baseline to endpoint.

METHODS: Participants were contacted while still on the inpatient ward and randomized 1:1 to a CRT or Treatment as Usual (TAU) group for four weeks. In both groups, patients electronically self-monitored their daily mood, physical activity, sleep, and medication in the Monsenso Daybuilder (MDB) system. The MDB allows investigators and participants to simultaneously view a graphical display of registrations. An investigator phoned participants in both groups weekly to co-inspect data entry. In the CRT group, participants were also phoned between these scheduled calls if specific predefined trigger points for mood and sleep were seen on the daily inspection. Participants in the CRT group were provided with specialized CRT psychoeducation sessions right after inclusion, focusing on increasing zeitgeber input to the circadian system. A PowerPoint presentation were presented, and paper-based informative material and leaflets reviewed with the participants. In the CRT group, the CRT principles were brought into play at all telephone consultations whereas in the TAU group, phone calls focused on data entry in the MDB system. When discharged, all patients were treated at a specialized affective disorders service.

RESULTS: In all, 103 participants were included. Participants in the CRT group had a statistically significant larger HAM-D17 score reduction (P=.04) compared to the TAU group. In the self-monitored MDB data, we found a significantly better improvement in evening mood (P=.02), sleep quality (P=.04), earlier sleep onset (P=.009) and a longer sleep duration (P=.005) in the CRT compared to the TAU group. The day-to-day variability of mean daily and evening mood, sleep offset, sleep onset, and sleep quality were significantly lower in the CRT group (all P<.001). The user evaluation was positive for the CRT method and the MDB system.

CONCLUSIONS: In the CRT group we found a significantly better effect on depression and sleep measures compared with the TAU group. We also found significantly less day-to-day variability of daily sleep, mood parameters and activity parameters in the CRT compared to the TAU group. The delivery of the CRT method should be further refined and tested.

CLINICALTRIAL: ClinicalTrials.gov Identifier: NCT02679768.

INTERNATIONAL REGISTERED REPORT: RR2-doi: 10.1186/s12888-019-2101-z.