- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02679768
Electronic Self-monitoring on Regulation of the Sleep-wake Cycle to Reduce Relapse of Depression After Discharge (SAFEII)
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?
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 (www.Daybuilder.com). 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Psychiatic Hospital Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Circadian Reinforcement Therapy
Circadian reinforcement therapy
|
Circadian reinforcement therapy plus electronical monitoring.
Circadian reinforcement therapy is a specialized psychoeducation working with strengthening of circadian rhythms.
|
PLACEBO_COMPARATOR: Standard treatment
|
Standard treatment plus electronical monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood
Time Frame: 28 days
|
Selfassessed mood rating from electronically entered data
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission
Time Frame: 28 days
|
Number of readmissions
|
28 days
|
Interviewer based mood
Time Frame: 28 days
|
Hamilton depression rating scale scores
|
28 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAFEII
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Circadian Reinforcement Therapy
-
Assaf-Harofeh Medical CenterHadassah Medical Organization; Western University, CanadaNot yet recruitingADHD | Memory Impairment | T1DM | Sleep Disorders, Circadian Rhythm
-
Sun Yat-sen UniversitySalus UniversityNot yet recruitingIntermittent Exotropia
-
University of UtahRecruitingSleep | Type 2 Diabetes | Overweight and Obesity | Insulin Sensitivity | Time Restricted Feeding | Sleep Hygiene | Cardiometabolic Syndrome | Eating Habit | Lifestyle FactorsUnited States
-
UConn HealthNational Institute on Drug Abuse (NIDA)CompletedMental Disorders | Cannabis Use Disorder | Addictive BehaviorsUnited States
-
Hospital Regional de Alta Especialidad del BajioCompleted
-
Societa Italiana di Chirurgia ColoRettaleUnknown
-
Karolinska InstitutetStockholm South General HospitalRecruiting
-
Centre for Addiction and Mental HealthRecruitingCognitive Impairment | Major Depressive Disorder | Cannabis UseCanada
-
University of AarhusAarhus University Hospital; Rigshospitalet, Denmark; Glostrup University Hospital... and other collaboratorsCompletedTraumatic Brain Injury (TBI) | Agitated BehaviourDenmark
-
University of ChicagoRecruiting