NCT03405493已完成不适用
Sleep, Wake and Light Therapy for Depression
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants recruited per month/Adherence to the protocol
研究概览
简要总结
The aim of this study is to determine if altering the pattern of one's sleep and having light therapy can speed up the treatment of depression. In the UK, the large majority of patients with depression in the NHS are treated in the community, and one of the major objectives of the study one is to determine if this therapy is a practical treatment in the community. We will be comparing two treatments:
- Sleep Therapy and a Light Box: Participants will be given information and advice on how to get a good night's sleep. Participants will be given a light box to use in the morning for 1 week. Treatment with a light box will last 30 minutes when a person gets up. Participants may continue to have any treatment as usual (for example medication or talking therapies).
- Wake therapy and a Light Box: Participants will be helped to change the pattern of sleep by depriving participants of sleep for one night. Participants will go bed at 5pm on the following day for 8 hours and get up at 1am. Participants' sleep will then be advanced by 2 hours each night for the next three nights. Participants will be also given a light box to use in the morning for 1 week. Treatment with a light box will last 30 minutes when participants get up. Participants may continue to have any treatment as usual (for example medication or talking therapies).
详细描述
- Participants will be given a wristband (Actigraph)
- Participants will be asked to complete various questionnaires and be interviewed at 1 week, 2 weeks, 4 weeks, 8 weeks and at 6 months after starting.
- Participants will be asked to make 6 extra visits to the research team at the hospital over and above those needed for normal care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Depressive Episode (ICD10 F32) or Recurrent Depressive Disorder (F33).
- •Minimum score of 8 or more on the Hamilton Depression Rating Scale (6 item) (Range 0-22) (Bech,1981).
- •Age 18-65
- •Able to give informed consent
- •Women of child bearing age may be included and no methods of contraception is required to enable inclusion into the trial.
排除标准
- •Current diagnosis of Seasonal Affective Disorder
- •Current diagnosis of anorexia nervosa or bulimia.
- •Current diagnosis of an obsessive compulsive or related disorder
- •Current diagnosis of post-traumatic stress disorder
- •History of schizophrenia, schizoaffective disorder or bipolar disorder
- •Severe cognitive impairment, dementia, intellectual disability or organic brain disorder.
- •History of stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence in past 3 months.
- •Borderline Personality Disorder or other personality disorder considered to be the main problem.
- •Duration of depression more than 2 years.
- •Significant risk of suicide that requires hospitalisation.
- •Severe eye disease or cataracts or traumatic injury or visual impairment affecting both eyes.
- •History of epilepsy, uncontrolled severe headaches, or stroke as this may lower seizure threshold through sleep deprivation.
- •Unstable medical condition that would make wake therapy intolerable
- •Untreated sleep disorder such as obstructive sleep apnoea or narcolepsy
- •Use of photo-sensitizing drugs.
- •Current night-shift work.
- •Non-English speaker.
研究组 & 干预措施
Wake and Light Therapy
Experimental
This consists of (a) Total Sleep Deprivation with group support on days one and two; (b) Phase Advance of Sleep over 5 days and daily Light Therapy. (c) Light Therapy is given daily
干预措施: Wake and Light Therapy (Behavioral)
Sleep and Light Therapy
Active Comparator
Participants will be given information on sleep hygiene and getting a good night's sleep. They are then given Light Therapy daily for 1 week.
干预措施: Sleep and Light Therapy (Behavioral)
结局指标
主要结局
Number of participants recruited per month/Adherence to the protocol
时间窗: Week 1
To compare the rate of recruitment and adherence to the treatments in both groups
次要结局
- Pittsburgh Sleep Index (Bysse et al., 1999) Questionnaire(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
- Euroquol 5D (1990) Questionnaire(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
- To check the amount of current psychotherapy use(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
- Brief Ruminative Response Scale (Topper et al, 2014). Questionnaire(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
- Daily sleep diary(3 days pre-randomisation and 7 days post-randomisation)
- To check the amount of current antidepressant use(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
- Credibility and Expectancy Questionnaire (Devilly, 2000).(Baseline)
- Morning/Evening Questionnaire(3 days pre-randomisation)
- MINI International Neuropsychiatric Interview Version 5.0(Baseline)
- Clinical Global Impression and Improvement Scale (Guy, 1976)(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
- Quick Inventory of Depressive Symptomatology -SR Version (Triveni et al., 2004) Questionnaire(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
- Wrist actigraph from GeneActiv daily (Physiological parameter)(3 days pre-randomisation and 7 days post-randomisation.)
- Hamilton Depression Rating Scale(Baseline, and at 1, 2, 4, 8 weeks and 6-month post-randomisation)
研究者
研究点 (1)
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