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

NCT02679768 | Completed

• 1 other identifier: SAFEII
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Mood

  Selfassessed mood rating from electronically entered data

  28 days

Secondary Outcomes (2)

• Readmission

  28 days

• Interviewer based mood

  28 days

Study Arms (2)

Circadian Reinforcement Therapy

ACTIVE COMPARATOR

Circadian reinforcement therapy

Behavioral: Circadian Reinforcement Therapy

Standard treatment

PLACEBO COMPARATOR

Standard treatment

Behavioral: Standard treatment

Interventions

Circadian Reinforcement Therapy BEHAVIORAL

Circadian reinforcement therapy plus electronical monitoring. Circadian reinforcement therapy is a specialized psychoeducation working with strengthening of circadian rhythms.

Circadian Reinforcement Therapy

Standard treatment BEHAVIORAL

Standard treatment plus electronical monitoring

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depression as defined in DSM-5
• Hospitalized at a psychiatric inpatient ward
• Age above 18

You may not qualify if:

• 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
• Abuse of alcohol or other drugs that might influence the ability to comply with study rules
• Patients under any form of coercion

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Psychiatic Hospital Copenhagen

Copenhagen, Denmark, 2100, Denmark

Location

Related Publications (2)

• Aggestrup AS, Svendsen SD, Praestegaard A, Loventoft P, Norregaard L, Knorr U, Dam H, Frokjaer E, Danilenko K, Hageman I, Faurholt-Jepsen M, Kessing LV, Martiny K. Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial. JMIR Ment Health. 2023 Nov 27;10:e50072. doi: 10.2196/50072.

  PMID: 37800194 DERIVED

• Dunker Svendsen S, Aggestrup AS, Norregaard LB, Loventoft P, Praestegaard 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.

  PMID: 31023274 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Clinical Associate Research Professor, Ph.D.

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 10, 2016
• Study Start: September 1, 2016
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)