Chronotherapy for Depressive Episodes

NCT05691647 | Recruiting

• 1 other identifier: 480812
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depressive Episode

Outcome Measures

Primary Outcomes (1)

• Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization

  Assessed with the Inventory of Depressive Symptomatology Self-Report (IDS-SR), a 30-item questionnaire assessing depressive symptomatology. Items are rated on a Likert scale from 0 to 3, with higher scores indicating more depressive symptoms. The range is 0-84.

  1 week after randomization

Secondary Outcomes (60)

• Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization.

  1 week after randomization

• Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization

  2 weeks after randomization

• Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization.

  4 weeks after randomization

• Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization

  8 weeks after randomization

• Between-group difference in observer-rated levels of depressive symptoms at week 24 after randomization

  24 weeks after randomization

Study Arms (2)

Chronotherapy + treatment as usual

EXPERIMENTAL

Behavioral: Chronotherapy; Behavioral: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

medication, cognitive behavioral therapy, and other psychotherapies.

Behavioral: Treatment as usual

Interventions

Chronotherapy BEHAVIORAL

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 encouraged to adhere to the sleep schedule which presents the sleep-wake phase advancement and later stabilization of the sleep-wake phase. Light therapy is provided for half an hour every day from day four in the study. In addition to the chronotherapeutic interventions, the participants will receive treatment as usual (TAU) with their assigned therapist.

Chronotherapy + treatment as usual

Treatment as usual BEHAVIORAL

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 psychotherapies.

Chronotherapy + treatment as usual; Treatment as usual

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St. Olavs Hospital, Nidaros DPS

Trondheim, Norway

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Chronotherapy; Therapeutics

Central Study Contacts

Knut Langsrud, PhD, MD

CONTACT

+47 92647191; knut.langsrud@stolav.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not be applicable due to the nature of the study, in which participants randomized to receive chronotherapy plus treatment as usual will be admitted to the ward for a one-night sleep deprivation, and the participants and researchers will understand which intervention arm the participant is receiving. Researchers and participants will not be aware of randomization until after baseline-assessments are completed. Analyses will be conducted by a statistician who is blinded to intervention allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 20, 2023
• Study Start: April 12, 2023
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2040
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)