NCT05691647招募中不适用
Chronotherapy for Patients With a Depressive Episode in a Public Mental Health Care Clinic in Norway: A Randomized Controlled Trial
St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. 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-
- •Must be able to communicate in a Scandinavian language
排除标准
- •. 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).
结局指标
主要结局
Between-group difference in self-reported levels of depressive symptoms at week 1 after randomization
时间窗: 1 week 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.
次要结局
- Between-group difference in self-reported anxiety symptoms at week 52 after randomization(52 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 self-reported anxiety symptoms at week 1 after randomization(1 week after randomization)
- Between-group difference in self-reported insomnia symptoms at week 8 after randomization(8 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 24 after randomization(24 weeks after randomization)
- Between-group difference in self-reported anxiety symptoms at week 2 after randomization.(2 weeks after randomization)
- Between-group difference in self-reported anxiety symptoms at week 24 after randomization(24 weeks after randomization)
- Prospective daily sleep-wake pattern at day 3 after randomization(3 days after randomization.)
- Between-group difference in self-reported anxiety symptoms at week 8 after randomization(8 weeks after randomization)
- Prospective daily sleep-wake pattern at week 1 after randomization.(1 week after randomization.)
- General health and health-related quality of life at week 2.(2 weeks after randomization.)
- Quality-adjusted life years (QALY) at week 2 after randomization(Week 2 after randomization)
- 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 52 after randomization(52 weeks after randomization)
- Between-group difference in self-reported anxiety symptoms at week 4 after randomization(4 weeks after randomization)
- Between-group difference in self-reported insomnia symptoms at week 1 after randomization(1 week after randomization)
- Between-group difference in self-reported insomnia symptoms at week 2 after randomization.(2 weeks after randomization)
- Between-group difference in self-reported insomnia symptoms at week 24 after randomization(24 weeks after randomization)
- Prospective daily sleep-wake pattern at day 4 after randomization.(4 days after randomization.)
- Prospective daily sleep-wake pattern at week 8 after randomization(8 weeks after randomization.)
- Work and social adjustment at week 1.(1 week after randomization.)
- Between-group difference in self-reported insomnia symptoms at week 4 after randomization(4 weeks after randomization)
- Between-group difference in self-reported insomnia symptoms at week 52 after randomization.(52 weeks after randomization)
- Prospective daily sleep-wake pattern at week 4 after randomization.(4 weeks after randomization.)
- Prospective daily sleep-wake pattern at week 52 after randomization(52 weeks after randomization.)
- Work and social adjustment at week 52(52 weeks after randomization)
- Serious adverse events will be assessed after 52 weeks after randomization.(52 weeks after randomization.)
- Use of health care services at 10 years after randomization.(10 years after randomization.)
- Between-group difference in self-reported levels of depressive symptoms at week 8 after randomization(8 weeks after randomization)
- Between-group difference in self-reported levels of depressive symptoms at week 24 after randomization(24 weeks after randomization)
- Prospective daily sleep-wake pattern at week 24 after randomization.(24 weeks after randomization.)
- Chronotype at week 8 after randomization.(8 weeks after randomization)
- General health and health-related quality of life at week 1(1 week after randomization.)
- General health and health-related quality of life at week 4.(4 weeks after randomization.)
- General health and health-related quality of life at week 24(24 weeks after randomization.)
- Use of health care services at 52 weeks after randomization.(52 weeks after randomization)
- Use of health care services at 5 years after randomization(5 years after randomization)
- Between-group difference in self-reported levels of depressive symptoms at day 3 after randomization(3 days after randomization)
- Subjective sleepiness during sleep deprivation(Day 3-4 after randomization)
- Prospective daily sleep-wake pattern at week 2 after randomization.(2 weeks after randomization.)
- Work and social adjustment at week 2.(2 weeks after randomization.)
- Work and social adjustment at week 24(24 weeks after randomization)
- General health and health-related quality of life at week 8(8 weeks after randomization.)
- General health and health-related quality of life at week 52.(52 weeks after randomization.)
- Patient satisfaction and experienced negative effects at week 4 after randomization(4 weeks after randomization.)
- Quality-adjusted life years (QALY) at week 24 after randomization(Week 24 after randomization)
- Work and social adjustment at week 4.(4 weeks after randomization)
- Work and social adjustment at week 8.(8 weeks after randomization)
- Between-group difference in self-reported levels of depressive symptoms at day 4 after randomization(4 days after randomization)
- Between-group difference in self-reported levels of depressive symptoms at week 2 after randomization(14 days after randomization)
- Between-group difference in self-reported levels of depressive symptoms at week 4 after randomization(4 weeks after randomization)
- Prospective daily sleep-wake pattern at day -7 before randomization.(Day -7 before randomization.)
- Between-group difference in self-reported levels of depressive symptoms at week 52 after randomization(52 weeks after randomization)
- Expectations to the interventions at baseline(Day 0 after randomization)
- Quality-adjusted life years (QALY) at week 1 after randomization(Week 1 after randomization)
- Quality-adjusted life years (QALY) at week 4 after randomization(Week 4 after randomization)
- Quality-adjusted life years (QALY) at week 8 after randomization(Week 8 after randomization)
- Quality-adjusted life years (QALY) at week 52 after randomization(Week 52 after randomization)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Chronobiology and Depression: Circadian Analytics as a Biomarker for Depressive SubtypesDepression, BipolarDepression, UnipolarHealthyNCT03538275Medibio Limited80
已完成
2 期
Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive DisorderMajor DepressionNCT02484456National Institute of Mental Health (NIMH)22
撤回
2 期
Neuroimaging Predictors of Antidepressant Treatment OutcomeDepressionNCT02000726University of Michigan
已完成
4 期
Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early ImprovementMajor DepressionNCT01458626Capital Medical University525
已完成
1 期
Rapid Antidepressant Effects of Ketamine in Major DepressionMood DisordersMajor DepresssionDepressionNCT00088699National Institute of Mental Health (NIMH)67