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Electronic Self-monitoring on Regulation of the Sleep-wake Cycle to Reduce Relapse of Depression After Discharge (SAFEII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02679768
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : September 23, 2020
Information provided by (Responsible Party):
Klaus Martiny, Mental Health Centre Copenhagen

Tracking Information
First Submitted Date  ICMJE February 8, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE September 1, 2016
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Mood [ Time Frame: 28 days ]
Selfassessed mood rating from electronically entered data
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • Readmission [ Time Frame: 28 days ]
    Number of readmissions
  • Interviewer based mood [ Time Frame: 28 days ]
    Hamilton depression rating scale scores
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Electronic Self-monitoring on Regulation of the Sleep-wake Cycle to Reduce Relapse of Depression After Discharge
Official Title  ICMJE 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?
Brief 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.

Detailed Description

SAFE II Background Patients hospitalized with a depression are generally discharged within 4-6 weeks, but remain vulnerable, and not fully recovered at discharge, hence a majority will be referred to outpatient care. Often, however, patients have to wait for about 2 weeks from discharge to first visit in the outpatient clinic. Our clinical experience is that this period from discharge to start of outpatient care is associated with psychological uncertainty and often cause unstable daily routines for sleep, meals, social life, and exercise. This may result in aggravation of the depression with the associated risk of suicidal thoughts and readmission. Our first study "E-monitoring by depression - Safe I," illustrated these issues. Patients registered their state daily in an electronical application, for sleep, mood, and exercise. Among other things the study showed that the patients' sleep patterns were advanced to later in the evening and longer in the morning thus shifting the sleep-wake cycle to later. One possible explanation for this finding is that patients are not recovered from the depression when discharged and therefore are more vulnerable to changes. Another possible factor is that at home the patients do not have the same support to keep daily structure as during hospitalization. This project "Safe discharge - SafeII" is based on the experience from the first study and will investigate whether a focused intervention in the benefits of a stable sleep in the recovery of a depression can help prevent worsening of the depression in the waiting time for outpatient treatment. It is well documented that stable sleep and circadian rhythm is an important element in the recovery of a depression.

Aim The purpose is to examine whether focused guidance to improve sleep habits and circadian rhythms can speed up recovery and also prevent worsening of depression and thus prevent readmission.

Design and Methods All patients hospitalized at PCK (Psychiatric Center Copenhagen) with a unipolar depression, and referred to outpatient treatment at the Intensive outpatient unit for affective disorders) (IAA) at discharge, are eligible for inclusion. Patient agreeing to participate will be randomized to one of two groups. The standard care group consists of patients who will be asked to register their mental state on a daily basis (mood, sleep and exercise) in the electronical application Daybuilder ( This standard group will have weekly telephone contact with the investigators. The intervention group will also be asked to register their daily state in the Daybuilder app and have weekly telephone contact with the investigators. In addition to standard care this group will also receive individual guidance concerning the importance of stabilization of the sleep-wake cycle and sleep to recover from depression. The primary outcomes of the study are changes in self-rated mood and changes in Hamilton depression rating scores at baseline and endpoint in the two groups and number of readmissions. We expect that the intervention group will have a more rapid recovery of depression and have fewer readmissions. Furthermore, in a subset of patients, the levels of the sleep hormone melatonin, a biological marker of circadian rhythms, is measured, as a profile to establish the dim light melatonin onset (DLMO) at the start and end of the intervention. At total of 150 patients, 75 in each group will be included in the project over a three year period In this study we get the opportunity to see the isolated impact of focusing on sleep and circadian rhythm in the recovery from depression. We have coined this intervention Circadian Reinforcement Therapy (CRT).

Implications If the findings are positive, we expect to implement the intervention more systematically in the psychiatric services thereby improving the conditions of patients with depression by making the transition from in- to outpatient status less risky and more stable. In the long term perspective the intervention can underpin recovery from depression, and prevent relapse into depression and readmission in mental hospital.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Behavioral: Circadian Reinforcement Therapy
    Circadian reinforcement therapy plus electronical monitoring. Circadian reinforcement therapy is a specialized psychoeducation working with strengthening of circadian rhythms.
  • Behavioral: Standard treatment
    Standard treatment plus electronical monitoring
Study Arms  ICMJE
  • Active Comparator: Circadian Reinforcement Therapy
    Circadian reinforcement therapy
    Intervention: Behavioral: Circadian Reinforcement Therapy
  • Placebo Comparator: Standard treatment
    Standard treatment
    Intervention: Behavioral: Standard treatment
Publications * Dunker Svendsen S, Aggestrup AS, Nørregaard LB, Løventoft P, Præstegaard A, Danilenko KV, Frost M, Knorr U, Hageman I, Vedel Kessing L, Martiny K. Circadian reinforcement therapy in combination with electronic self-monitoring to facilitate a safe post-discharge period of patients with depression by stabilizing sleep: protocol of a randomized controlled trial. BMC Psychiatry. 2019 Apr 25;19(1):124. doi: 10.1186/s12888-019-2101-z.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Klaus Martiny, PhD, DMSC 0045-38647100
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02679768
Other Study ID Numbers  ICMJE SAFEII
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The Danish National Archives
Responsible Party Klaus Martiny, Mental Health Centre Copenhagen
Study Sponsor  ICMJE Mental Health Centre Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mental Health Centre Copenhagen
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP