Project

SAFE II

Goal: Using Circadian Reinforcement Therapy CRT to stabilise mood and sleep in patients discharged from inpatients wards with depression.

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Klaus Martiny
added 3 research items
The SAFE study Louise Andersen1, Emilia Olsson1, Lasse Benn Nørregaard2, Philip Løventoft2, Klaus Martiny1 1 Intensive care outpatient unit for affective disorders (IAA) Mental Health Centre Copenhagen, department O, 2Daybuilder Fogedmarken 8, 7 th, 2200 København N. Presenting author: Louise.andersen.04@regionh.dk Background and aim: We know very little of what happens when patients with depression are discharged from inpatient wards. In the wards patients are kept in a sheltered environment with a stable sleep wake cycle, regular meals and regular physical activities. At the Intensive care outpatient unit for affective disorders (IAA) we receive patients discharged from hospital. From case records and through Hamiltons interview we speculated whether these patient deteriorate when discharged. Materials and methods: Patient referred to the IAA from affective disorders wards, were included in the study. All patients was instructed to use the Daybuilder PC application and registered daily mood, sleep onset, sleep offset, sleep naps, sleep quality, exercise and medication adherence for a four week period including: some days on the ward, some days without psychiatric assistance, and a period at the IAA. Results: Preliminary results from 16 patients are presented. Mean sleep onset was 22:56 (3:36) hour:minutes at baseline (mean of days one till three) and 23:46 ( 1:23) hour:minutes at endpoint (mean of days 26 to 28). Mean sleep offset was 6:33 (1:33) hour:minutes at baseline and 8:14 at endpoint (1:41). Linear regression showed sleep onset to be delayed by 1.5 minutes per day (p=0.07) and sleep offset delayed by 1.6 minutes per day (p=0.03). Hamilton 17 items score was 19.7 (6.1) at baseline and 17.5 (6.5) at endpoint. Mood registration showed large day-to-day variation and a tendency for worsening of mood in the days after discharge but with improvement after inclusion at the IAA. Conclusion: Sleep was delayed after discharge. Sleep delay is known to be depressiogenic. Day-to-day mood and sleep was highly variable. Electronic monitoring with the Daybuilder application coupled with weekly feedback might help patient avoid a sleep delay and keep a more regular sleep pattern and thus prevent relapse. Study is ongoing and will include a total number of 45 patients.
Very little is known of depressed patients’ state in the period immediately after being discharged from inpatient wards. At the inpatient ward patients are in a sheltered environment and learn the importance of a stable rhythm of sleep and activities. This is enforced through supplying a regular timing of: sleep schedule, meals, physical activities, and medication administration. This works together as time signals (zeitgebers) that helps to stabilize the sleep-wake cycle and all internal rhythms. A newly developed computer system, Daybuilder, has made it possible for patients to perform daily self-monitoring of their depression severity, sleep, and activity, while their clinician at the same time can monitor these data in a closed loop system (see figure 1). We wanted to test the usability of this system by monitoring depressed patients condition when they were discharged from inpatient wards and until they started outpatient treatment at an intensive outpatient unit (IOU) approximately 2 weeks later. administration. This works together as time signals (zeitgebers) that helps to stabilize the sleep-wake cycle and all internal rhythms.
Very little is known about the stability of depressed patients’ state after discharge from inpatient wards. During hospitalization patients are provided with a sheltered environment. The time after discharge represents a vulnerable period with risk of a less regular everyday life with a potential negative impact on recovery from depression. In the SAFE I study, we showed that electronic self-monitoring was useful to gain insight into patients’ condition after discharge, and that patients in general were characterized by an unstable sleep-wake cycle with significantly delayed sleep and unstable mood (n=45).
Klaus Martiny
added a research item
Background The transition phase from inpatient to outpatient care for patients suffering from Major Depressive Disorder represents a vulnerable period associated with a risk of depression worsening and suicide. Our group has recently found that the sleep-wake cycle in discharged depressive patients became irregular and exhibited a drift towards later hours, associated with worsening of depression. In contrast, an advancement of sleep phase has earlier been shown to have an antidepressant effect. Thus, methods to prevent drift of the sleep-wake cycle may be promising interventions to prevent or reduce worsening of depression after discharge. Methods In this trial, we apply a new treatment intervention, named Circadian Reinforcement Therapy (CRT), to patients discharged from inpatient psychiatric wards. CRT consists of a specialized psychoeducation on the use of regular time signals (zeitgebers): daylight exposure, exercise, meals, and social contact. The aim is to supply stronger and correctly timed zeitgebers to the circadian system to prevent sleep drift and worsening of depression. The CRT is used in combination with an electronic self-monitoring system, the Monsenso Daybuilder System (MDB). By use of the MDB system, all patients self-monitor their sleep, depression level, and activity (from a Fitbit bracelet) daily. Participants can inspect all their data graphically on the MDB interface and will have clinician contact. The aim is to motivate patients to keep a stable sleep-wake cycle. In all, 130 patients referred to an outpatient service will be included. Depression rating is blinded. Patients will be randomized 1:1 to a Standard group or a CRT group. The intervention period is 4 weeks covering the transition phase from inpatient to outpatient care. The primary outcome is score change in interviewer rated levels of depression on the Hamilton Depression Rating Scale. A subset of patients will be assessed with salivary Dim Light Melatonin Onset (DLMO) as a validator of circadian timing. The trial was initiated in 2016 and will end in 2020. Discussion If the described intervention is beneficial it could be incorporated into usual care algorithms for depressed patients to facilitate a better and safer transition to outpatient treatment. Trial registration Posted prospectively at ClinicalTrials.gov at February 10, 2016 with identifier NCT02679768.
Klaus Martiny
added a research item
Background Patients suffering from depression have a high risk of relapse and readmission in the weeks following discharge from inpatient wards. Electronic self-monitoring systems that offer patient-communication features are now available to offer daily support to patients, but the usability, acceptability, and adherence to these systems has only been sparsely investigated. Objective We aim to test the usability, acceptability, adherence, and clinical outcome of a newly developed computer-based electronic self-assessment system (the Daybuilder system) in patients suffering from depression, in the period from discharge until commencing outpatient treatment in the Intensive Outpatient Unit for Affective Disorders. Methods Patients suffering from unipolar major depression that were referred from inpatient wards to an intensive outpatient unit were included in this study before their discharge, and were followed for four weeks. User satisfaction was assessed using semiqualitative questionnaires and the System Usability Scale (SUS). Patients were interviewed at baseline and at endpoint with the Hamilton depression rating scale (HAM-D17), the Major Depression Inventory (MDI), and the 5-item World Health Organization Well-Being Index (WHO-5). In this four-week period patients used the Daybuilder system to self-monitor mood, sleep, activity, and medication adherence on a daily basis. The system displayed a graphical representation of the data that was simultaneously displayed to patients and clinicians. Patients were phoned weekly to discuss their data entries. The primary outcomes were usability, acceptability, and adherence to the system. The secondary outcomes were changes in: the electronically self-assessed mood, sleep, and activity scores; and scores from the HAM-D17, MDI, and WHO-5 scales. Results In total, 76% of enrolled patients (34/45) completed the four-week study. Five patients were readmitted due to relapse. The 34 patients that completed the study entered data for mood on 93.8% of the days (872/930), sleep on 89.8% of the days (835/930), activity on 85.6% of the days (796/930), and medication on 88.0 % of the days (818/930). SUS scores were 86.2 (standard deviation [SD] 9.7) and 79% of the patients (27/34) found that the system lived up to their expectations. A significant improvement in depression severity was found on the HAM-D17 from 18.0 (SD 6.5) to 13.3 (SD 7.3; P<.01), on the MDI from 27.1 (SD 13.1) to 22.1 (SD 12.7; P=.006), and in quality of life on the WHO-5 from 31.3 (SD 22.9) to 43.4 (SD 22.1; P<.001) scales, but not on self-assessed mood (P=.08). Mood and sleep parameters were highly variable from day-to-day. Sleep-offset was significantly delayed from baseline, averaging 48 minutes (standard error 12 minutes; P<.001). Furthermore, when estimating delay of sleep-onset (with sleep quality included in the model) during the study period, this showed a significant negative effect on mood (P=.03) Conclusions The Daybuilder systems performed well technically, and patients were satisfied with the system and had high adherence to self-assessments. The dropout rate and the gradual delay in sleep emphasize the need for continued clinical support for these patients, especially when considering sleep guidance.
Klaus Martiny
added a project goal
Using Circadian Reinforcement Therapy CRT to stabilise mood and sleep in patients discharged from inpatients wards with depression.