Clinical trial NCT05691647: Chronotherapy for Depressive Episodes
Official title: Chronotherapy for Patients With a Depressive Episode in a Public Outpatient Mental Health Care Clinic in Norway: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Episode
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 secondary mental health care outpatient 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 outpatient 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.


Eligibility criteria: Inclusion criteria. Patients eligible for the trial must comply with all the following at randomization:

* Being 18 years or older
* Willing and able to provide a written informed consent
* Newly diagnosed with an ongoing moderate or severe depressive episode according to the International Classification of Disorders 10th edition (ICD-10) and accepted for outpatient treatment for the depressive episode. The diagnosis is set in consensus of a licensed therapist and a specialist in psychiatry/psychology.
* The patient must score ≥ 9 on the Hamilton Depression Rating Scale-6.
* Must be able to communicate in a Scandinavian language

Exclusion criteria. Patients are considered ineligible for participation if any of the following are present:

* Illnesses where chronotherapy may be contraindicated (for example epilepsy, ongoing attack of multiple sclerosis, blindness, narcolepsy and psychotic depression).
* Known pregnancy.
* Individuals with a known diagnosis of emotionally unstable personality disorder (F60.3).
* Individuals with a known psychotic disorder
* Shiftwork or other related social or work circumstances that inhibit participation
* Participation in an ongoing trial at the outpatient clinic that encompasses digital cognitive behavior therapy for insomnia (recruitment to this trial will end in 2023).

Primary outcomes:
measure: Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization
timeFrame: 1 week after randomization
Secondary outcomes:
measure: Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization.
timeFrame: 1 week after randomization
measure: Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization
timeFrame: 2 weeks after randomization
measure: Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization.
timeFrame: 4 weeks after randomization
measure: Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization
timeFrame: 8 weeks after randomization
measure: Between-group difference in observer-rated levels of depressive symptoms at week 24 after randomization
timeFrame: 24 weeks after randomization
measure: Between-group difference in observer-rated levels of depressive symptoms at week 52 after randomization
timeFrame: 52 weeks after randomization
measure: Between-group difference in self-reported anxiety symptoms at week 1 after randomization
timeFrame: 1 week after randomization
measure: Between-group difference in self-reported anxiety symptoms at week 2 after randomization.
timeFrame: 2 weeks after randomization
measure: Between-group difference in self-reported anxiety symptoms at week 4 after randomization
timeFrame: 4 weeks after randomization
measure: Between-group difference in self-reported anxiety symptoms at week 8 after randomization
timeFrame: 8 weeks after randomization
measure: Between-group difference in self-reported anxiety symptoms at week 24 after randomization
timeFrame: 24 weeks after randomization
measure: Between-group difference in self-reported anxiety symptoms at week 52 after randomization
timeFrame: 52 weeks after randomization
measure: Between-group difference in self-reported insomnia symptoms at week 1 after randomization
timeFrame: 1 week after randomization
measure: Between-group difference in self-reported insomnia symptoms at week 2 after randomization.
timeFrame: 2 weeks after randomization
measure: Between-group difference in self-reported insomnia symptoms at week 4 after randomization
timeFrame: 4 weeks after randomization
measure: Between-group difference in self-reported insomnia symptoms at week 8 after randomization
timeFrame: 8 weeks after randomization
measure: Between-group difference in self-reported insomnia symptoms at week 24 after randomization
timeFrame: 24 weeks after randomization
measure: Between-group difference in self-reported insomnia symptoms at week 52 after randomization.
timeFrame: 52 weeks after randomization
measure: Prospective daily sleep-wake pattern at day 3 after randomization
timeFrame: 3 days after randomization.
measure: Prospective daily sleep-wake pattern at day 4 after randomization.
timeFrame: 4 days after randomization.
measure: Prospective daily sleep-wake pattern at week 1 after randomization.
timeFrame: 1 week after randomization.
measure: Prospective daily sleep-wake pattern at week 2 after randomization.
timeFrame: 2 weeks after randomization.
measure: Prospective daily sleep-wake pattern at week 4 after randomization.
timeFrame: 4 weeks after randomization.
measure: Prospective daily sleep-wake pattern at week 8 after randomization
timeFrame: 8 weeks after randomization.
measure: Prospective daily sleep-wake pattern at week 24 after randomization.
timeFrame: 24 weeks after randomization.
measure: Prospective daily sleep-wake pattern at week 52 after randomization
timeFrame: 52 weeks after randomization.
measure: Chronotype at week 8 after randomization.
timeFrame: 8 weeks after randomization
measure: Work and social adjustment at week 1.
timeFrame: 1 week after randomization.
measure: Work and social adjustment at week 2.
timeFrame: 2 weeks after randomization.
measure: Work and social adjustment at week 4.
timeFrame: 4 weeks after randomization
measure: Work and social adjustment at week 8.
timeFrame: 8 weeks after randomization
measure: Work and social adjustment at week 24
timeFrame: 24 weeks after randomization
measure: Work and social adjustment at week 52
timeFrame: 52 weeks after randomization
measure: General health and health-related quality of life at week 1
timeFrame: 1 week after randomization.
measure: General health and health-related quality of life at week 2.
timeFrame: 2 weeks after randomization.
measure: General health and health-related quality of life at week 4.
timeFrame: 4 weeks after randomization.
measure: General health and health-related quality of life at week 8
timeFrame: 8 weeks after randomization.
measure: General health and health-related quality of life at week 24
timeFrame: 24 weeks after randomization.
measure: General health and health-related quality of life at week 52.
timeFrame: 52 weeks after randomization.
measure: Patient satisfaction and experienced negative effects at week 4 after randomization
timeFrame: 4 weeks after randomization.
measure: Serious adverse events will be assessed after 52 weeks after randomization.
timeFrame: 52 weeks after randomization.
measure: Use of health care services at 52 weeks after randomization.
timeFrame: 52 weeks after randomization
measure: Use of health care services at 5 years after randomization
timeFrame: 5 years after randomization
measure: Use of health care services at 10 years after randomization.
timeFrame: 10 years after randomization.
measure: Between-group difference in self-reported levels of depressive symptoms at day 3 after randomization
timeFrame: 3 days after randomization
measure: Between-group difference in self-reported levels of depressive symptoms at day 4 after randomization
timeFrame: 4 days after randomization
measure: Between-group difference in self-reported levels of depressive symptoms at week 2 after randomization
timeFrame: 14 days after randomization
measure: Between-group difference in self-reported levels of depressive symptoms at week 4 after randomization
timeFrame: 4 weeks after randomization
measure: Between-group difference in self-reported levels of depressive symptoms at week 8 after randomization
timeFrame: 8 weeks after randomization
measure: Between-group difference in self-reported levels of depressive symptoms at week 24 after randomization
timeFrame: 24 weeks after randomization
measure: Between-group difference in self-reported levels of depressive symptoms at week 52 after randomization
timeFrame: 52 weeks after randomization
measure: Subjective sleepiness during sleep deprivation
timeFrame: Day 3-4 after randomization
measure: Expectations to the interventions at baseline
timeFrame: Day 0 after randomization
measure: Quality-adjusted life years (QALY) at week 1 after randomization
timeFrame: Week 1 after randomization
measure: Quality-adjusted life years (QALY) at week 2 after randomization
timeFrame: Week 2 after randomization
measure: Quality-adjusted life years (QALY) at week 4 after randomization
timeFrame: Week 4 after randomization
measure: Quality-adjusted life years (QALY) at week 8 after randomization
timeFrame: Week 8 after randomization
measure: Quality-adjusted life years (QALY) at week 24 after randomization
timeFrame: Week 24 after randomization
measure: Quality-adjusted life years (QALY) at week 52 after randomization
timeFrame: Week 52 after randomization
measure: Prospective daily sleep-wake pattern at day -7 before randomization.
timeFrame: Day -7 before randomization.
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Nidaros DPS
Study officials:
References: