Chronotherapy for Depressive Episodes
ConditionDepressive Episode
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSt. Olavs Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Chronotherapy
BehavioralChronotherapy 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.
Treatment as usual
BehavioralParticipants 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Chronotherapy + treatment as usualExperimental treatment 2 interventions
Group B: Treatment as usualActive comparator 1 intervention
Trial outcomes
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.
Time frame
1 week after randomizationSecondary outcomes
1
Between-group difference in observer-rated levels of depressive symptoms at week 1 after randomization.
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time frame
1 week after randomization2
Between-group difference in observer-rated levels of depressive symptoms at week 2 after randomization
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time frame
2 weeks after randomization3
Between-group difference in observer-rated levels of depressive symptoms at week 4 after randomization.
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time frame
4 weeks after randomization4
Between-group difference in observer-rated levels of depressive symptoms at week 8 after randomization
Assessed with the Hamilton Depression Rating Scale (HDRS-6), a 6-item questionnaire for depressive symptoms the last 24 hours. Each item is rated on a 0 to 4 rating scale with higher scores indicating more depressive symptoms. The range is 0-22.
Time frame
8 weeks after randomizationSponsors and contacts
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Source ClinicalTrials.gov