Chronotherapy for Depressive Episodes

St. Olavs Hospital

Status: Enrolling

Conditions: Depressive Episode

Treatments: Behavioral: Chronotherapy; Behavioral: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05691647

480812

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Chronotherapy + treatment as usual

Experimental group

Treatment:

Behavioral: Treatment as usual

Behavioral: Chronotherapy

Treatment as usual

Active Comparator group

Description:

medication, cognitive behavioral therapy, and other psychotherapies.

Treatment:

Behavioral: Treatment as usual