Chronotherapy for Depressive Episodes

Last updated: December 30, 2025
Sponsor: St. Olavs Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

Treatment as usual

Chronotherapy

Clinical Study ID

NCT05691647
480812
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 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 and treatments where chronotherapy may be contraindicated (for example epilepsy, ongoing attack of multiple sclerosis, blindness, narcolepsy and psychotic depression, ECT treatment).

  • 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).

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: Treatment as usual
Phase:
Study Start date:
April 12, 2023
Estimated Completion Date:
January 31, 2040

Connect with a study center

  • St. Olavs Hospital, Nidaros DPS

    Trondheim,
    Norway

    Site Not Available

  • St. Olavs Hospital, Nidaros DPS

    Trondheim 3133880,
    Norway

    Active - Recruiting

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