Chronotherapy for Patients With a Depressive Episode in a Public Mental Health Care Clinic in Norway: A Randomized Controlled Trial

St. Olavs Hospital1 site in 1 country76 target enrollmentApril 12, 2023

ConditionsDepressive Episode

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depressive Episode
Sponsor: St. Olavs Hospital
Enrollment: 76
Locations: 1
Primary Endpoint: Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. Chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better long-term effects and has been shown efficient to improve depressive symptoms. Interventions include sleep deprivation, sleep-phase advancement and stabilization, and light therapy. There are few studies testing the effectiveness of combining these three chronotherapeutic techniques in the initial phase of treatment of depression in a mental health care clinic. The investigators aim to test the effects and safety of chronotherapy in addition to TAU compared to TAU alone, with the primary outcome being self-reported depressive symptoms at 1 week following randomization. The study is a randomized controlled trial with 76 patients with a depressive episode who initiate treatment at Nidaros DPS, St. Olavs University Hospital. Participants will be allocated 1:1 to either chronotherapy + treatment as usual (TAU) or to TAU alone.

Registry

clinicaltrials.gov

Start Date

April 12, 2023

End Date

January 1, 2040

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

St. Olavs Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization

Time Frame: 1 week after randomization

Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

Secondary Outcomes

Between-group difference in self-reported anxiety symptoms at week 52 after randomization(52 weeks after randomization)
Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization(8 weeks after randomization)
Between-group difference in self-reported anxiety symptoms at week 1 after randomization(1 week after randomization)
Between-group difference in self-reported insomnia symptoms at week 8 after randomization(8 weeks after randomization)
Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization.(4 weeks after randomization)
Between-group difference in observer-rated levels of depressive symptoms at week 24 after randomization(24 weeks after randomization)
Between-group difference in self-reported anxiety symptoms at week 2 after randomization.(2 weeks after randomization)
Between-group difference in self-reported anxiety symptoms at week 24 after randomization(24 weeks after randomization)
Prospective daily sleep-wake pattern at day 3 after randomization(3 days after randomization.)
Between-group difference in self-reported anxiety symptoms at week 8 after randomization(8 weeks after randomization)
Prospective daily sleep-wake pattern at week 1 after randomization.(1 week after randomization.)
General health and health-related quality of life at week 2.(2 weeks after randomization.)
Quality-adjusted life years (QALY) at week 2 after randomization(Week 2 after randomization)
Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization.(1 week after randomization)
Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization(2 weeks after randomization)
Between-group difference in observer-rated levels of depressive symptoms at week 52 after randomization(52 weeks after randomization)
Between-group difference in self-reported anxiety symptoms at week 4 after randomization(4 weeks after randomization)
Between-group difference in self-reported insomnia symptoms at week 1 after randomization(1 week after randomization)
Between-group difference in self-reported insomnia symptoms at week 2 after randomization.(2 weeks after randomization)
Between-group difference in self-reported insomnia symptoms at week 24 after randomization(24 weeks after randomization)
Prospective daily sleep-wake pattern at day 4 after randomization.(4 days after randomization.)
Prospective daily sleep-wake pattern at week 8 after randomization(8 weeks after randomization.)
Work and social adjustment at week 1.(1 week after randomization.)
Between-group difference in self-reported insomnia symptoms at week 4 after randomization(4 weeks after randomization)
Between-group difference in self-reported insomnia symptoms at week 52 after randomization.(52 weeks after randomization)
Prospective daily sleep-wake pattern at week 4 after randomization.(4 weeks after randomization.)
Prospective daily sleep-wake pattern at week 52 after randomization(52 weeks after randomization.)
Work and social adjustment at week 52(52 weeks after randomization)
Serious adverse events will be assessed after 52 weeks after randomization.(52 weeks after randomization.)
Use of health care services at 10 years after randomization.(10 years after randomization.)
Between-group difference in self-reported levels of depressive symptoms at week 8 after randomization(8 weeks after randomization)
Between-group difference in self-reported levels of depressive symptoms at week 24 after randomization(24 weeks after randomization)
Prospective daily sleep-wake pattern at week 24 after randomization.(24 weeks after randomization.)
Chronotype at week 8 after randomization.(8 weeks after randomization)
General health and health-related quality of life at week 1(1 week after randomization.)
General health and health-related quality of life at week 4.(4 weeks after randomization.)
General health and health-related quality of life at week 24(24 weeks after randomization.)
Use of health care services at 52 weeks after randomization.(52 weeks after randomization)
Use of health care services at 5 years after randomization(5 years after randomization)
Between-group difference in self-reported levels of depressive symptoms at day 3 after randomization(3 days after randomization)
Subjective sleepiness during sleep deprivation(Day 3-4 after randomization)
Prospective daily sleep-wake pattern at week 2 after randomization.(2 weeks after randomization.)
Work and social adjustment at week 2.(2 weeks after randomization.)
Work and social adjustment at week 24(24 weeks after randomization)
General health and health-related quality of life at week 8(8 weeks after randomization.)
General health and health-related quality of life at week 52.(52 weeks after randomization.)
Patient satisfaction and experienced negative effects at week 4 after randomization(4 weeks after randomization.)
Quality-adjusted life years (QALY) at week 24 after randomization(Week 24 after randomization)
Work and social adjustment at week 4.(4 weeks after randomization)
Work and social adjustment at week 8.(8 weeks after randomization)
Between-group difference in self-reported levels of depressive symptoms at day 4 after randomization(4 days after randomization)
Between-group difference in self-reported levels of depressive symptoms at week 2 after randomization(14 days after randomization)
Between-group difference in self-reported levels of depressive symptoms at week 4 after randomization(4 weeks after randomization)
Prospective daily sleep-wake pattern at day -7 before randomization.(Day -7 before randomization.)
Between-group difference in self-reported levels of depressive symptoms at week 52 after randomization(52 weeks after randomization)
Expectations to the interventions at baseline(Day 0 after randomization)
Quality-adjusted life years (QALY) at week 1 after randomization(Week 1 after randomization)
Quality-adjusted life years (QALY) at week 4 after randomization(Week 4 after randomization)
Quality-adjusted life years (QALY) at week 8 after randomization(Week 8 after randomization)
Quality-adjusted life years (QALY) at week 52 after randomization(Week 52 after randomization)