Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT05691647

Chronotherapy for Depressive Episodes

Conditions: Depressive Episode

Sex: All
Ages: 18 Years – 100 Years
Phase: NA
Enrollment: 76
Sponsor: St. Olavs Hospital

Location: Norway

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 olderWilling and able to provide a written informed consentNewly 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 languageExclusion 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 disorderShiftwork or other related social or work circumstances that inhibit participationParticipation in an ongoing trial at the outpatient clinic that encompasses digital cognitive behavior therapy for insomnia (recruitment to this trial will end in 2023).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05691647). StuddyBuddy aggregates publicly available trial information.