Chronotherapy for Depressive Episodes

Official title

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

Overview

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.

Interventions

• Behavioral Chronotherapy
  Chronotherapy involves three different interventions. Sleep deprivation/wake therapy will be conducted for 34 hours. To assist wake and to ensure that the participants adhere to the sleep deprivation, outpatients will be admitted to a one-night stay at the inpatient ward that is connected to the outpatient clinic at Nidaros DPS. Patients already admitted to inpatient treatment will be temporary transferred to the ward selected to oversee the sleep deprivation. Upon discharge, participants are en
• Behavioral Treatment as usual
  Participants allocated to receive TAU alone, will receive standard treatment for a depressive episode in the outpatient or the inpatient clinic. This study will not give restrictions or guidelines on how this treatment should be performed. The TAU-group will receive the treatment the responsible therapist considers and evaluate best fitting in the situation. Typical interventions administered in therapy for a depressive episode includes medication, cognitive behavioral therapy, and other psychot

Primary outcome measures

• Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization [Time frame: 1 week after randomization]

Secondary outcome measures (12)

• Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization. [Time frame: 1 week after randomization]
• Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization [Time frame: 2 weeks after randomization]
• Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization. [Time frame: 4 weeks after randomization]
• Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization [Time frame: 8 weeks after randomization]
• Between-group difference in observer-rated levels of depressive symptoms at week 24 after randomization [Time frame: 24 weeks after randomization]
• Between-group difference in observer-rated levels of depressive symptoms at week 52 after randomization [Time frame: 52 weeks after randomization]
• Between-group difference in self-reported anxiety symptoms at week 1 after randomization [Time frame: 1 week after randomization]
• Between-group difference in self-reported anxiety symptoms at week 2 after randomization. [Time frame: 2 weeks after randomization]
• Between-group difference in self-reported anxiety symptoms at week 4 after randomization [Time frame: 4 weeks after randomization]
• Between-group difference in self-reported anxiety symptoms at week 8 after randomization [Time frame: 8 weeks after randomization]
• Between-group difference in self-reported anxiety symptoms at week 24 after randomization [Time frame: 24 weeks after randomization]
• Between-group difference in self-reported anxiety symptoms at week 52 after randomization [Time frame: 52 weeks after randomization]

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 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Norway · 1 center

• St. Olavs Hospital, Nidaros DPS — Trondheim

Publications

• Ramfjord LS, Kahn N, Langsrud K, Halvorsen JOO, Morken G, Saksvik S, Engvik LSS, Lydersen S, Kallestad H. Chronotherapy for patients with a depressive episode treated in a public outpatient mental healthcare clinic in Norway: protocol for a randomised controlled trial. BMJ Open. 2024 Jan 3;14(1):e076039. doi: 10.1136/bmjopen-2023-076039. PMID 38171633

Identifiers

NCT: NCT05691647 · 480812

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗