Does CBT Improve the Effect of Light Therapy in Delayed Sleep Phase Syndrome Compared to Only Light Therapy - Short and Long Term Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change from baseline in sleep-diary at 6 months.
研究概览
简要总结
Delayed sleep phase syndrome (DSPS) is the most common of the circadian rhythm sleep disorders (CRSD). A person with DSPS have sufficient sleep quality, but their circadian clock is delayed compared to the normal 24-h period. They fall asleep around 03.00-04.00 at night and sleeps until 02.00-03.00 in the afternoon. This syndrome is most frequent among young people between 16-25 years, which conveys that school attendance and education are affected, and also often results in severe social consequences. DSPS is sometimes associated with depression and personality disorders and may aggravate psychiatric symptoms.
This syndrome is highly underdiagnosed and there are no detailed guidelines how to treat it. The treatment usually consists of light therapy, chronotherapy or melatonin. There is a lack of guidelines how often, with which wavelength, and how long the treatment of DSPS patients shall go on. Previous studies shows that light therapy often is effective. The effect gets even better if melatonin is administered concurrently. However, the frequency of relapse is high.
Thus, DSPS is a prevalent syndrome in young adults with severe consequences on normal daytime functioning. There are almost no treatment options available in health care settings. There is a clear need for further studies on this topic. The main purpose of the present study is to evaluate the clinical effects of short and long-term treatment by using light therapy and cognitive behaviour therapy (CBT). CBT is recommended at mild to moderate depression and anxiety. It also has some evidence in treating insomnia. Patients with DSPS often have al of these symptoms and therefore the investigators would like to investigate if CBT can enhance the effect of light therapy.
Firstly, the investigators want to evaluate the short-term effects of light therapy with and without CBT. Secondly, the investigators want to evaluate if the patients who get CBT maintain a "normal" sleep rhythm and prevent relapse of DSPS compared to just light therapy for two weeks.
The investigators also want to evaluate how this patient-group differs when it comes to behavioral factors compared to a matched reference group.
详细描述
DSPS patients delayed sleep and wake times are accompanied by insomnia and excessive sleepiness that results in functional impairments. The sleeping-problems and the impairment in important areas of functioning and quality of life sometimes lead to psychiatric problems such as, depressive symptoms, irritability, problems with their memory and concentration. It has not yet been fully established how long the treatment should go on, how long each light treatment should be, and the exact intensity of light. Although long-term studies on DSPS patients are sparse, it is known from clinical experience that these patients often fall back into their old circadian schedule after the treatment.
This study is a prospective randomised study. In the short-term study patients will be randomised to two groups. Group I light therapy (LT) for two weeks Group II LT for two weeks + CBT for four weeks. Group I and II will be followed up with questionnaires concerning depression/anxiety, sleepiness during the day, sleep-diary and insomnia-problems.
The aim is to evaluate if CBT enhance LT-treatment at home. The two groups will be followed with sleep-diary monthly and questionnaires.
Method. Questionnaires. All patients will fill in some questionnaires before the treatment starts, during treatment and at follow-up.
I) Horne-Ostberg Morning-Eveningness Questionnaire (MEQ) to measure their diurnality.
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
入排标准
- 年龄范围
- 16 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of delayed sleep phase syndrome.
排除标准
- •Eye diseases
- •Active psychiatric disorder.
- •Ongoing somatic disorder.
研究组 & 干预措施
Light therapy for two weeks
干预措施: Light therapy (Device)
Light therapy and CBT
Two weeks of light therapy and after that 4 weeks of Cognitive behaviour therapy (CBT)
干预措施: Light therapy and Cognitive behaviour therapy (Device)
结局指标
主要结局
Change from baseline in sleep-diary at 6 months.
时间窗: Change from baseline in sleep-diary at 6 months.
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier.
次要结局
- Changes from baseline in sleep-diary at 6 weeks.(Changes from baseline in sleep diary at 6 weeks.)
- Change from baseline in Hospital anxiety-depression scale at 6 weeks(Change from baseline in Hospital anxiety-depression scale at 6 weeks)
- Change from baseline in Hospital anxiety-depression scale at 6 months(Change from baseline in Hospital anxiety-depression scale at 6 months)
- Change from baseline in Insomnia Severity Scale at 6 weeks(Change from baseline in Insomnia Severity Scale at 6 weeks)
- Change from baseline in Epworth Sleepiness Scale at 6 months(Change from baseline in Epworth Sleepiness Scale at 6 months)
- Change from baseline in Symptom-focused Rumination Scale at 6 months(Change from baseline in Symptom-focused Rumination Scale at 6 months)
- Change from baseline in sleep-diary at 2 weeks(Change from baseline in sleep-diary at 2 weeks)
- Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months(Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months)
- Change from baseline in Hospital anxiety-depression scale at 2 weeks(Change from baseline in Hospital anxiety-depression scale at 2 weeks)
- Change from baseline in Insomnia Severity Scale at 6 months(Change from baseline in Insomnia Severity Scale at 6 months)
- Change from baseline in Epworth Sleepiness Scale at 6 weeks(Change from baseline in Epworth Sleepiness Scale at 6 weeks)
- Change from baseline in Brief COPE at 6 months(Change from baseline in Brief COPE at 6 months)
- Change from baseline in Insomnia Severity Scale at 2 weeks(Change from baseline in Insomnia Severity Scale at 2 weeks)
- Change from baseline in Epworth Sleepiness Scale at 2 weeks(Change from baseline in Epworth Sleepiness Scale at 2 weeks)
- Change from baseline in Penn State Worry Questionnaire at 6 months(Change from baseline in Penn State Worry Questionnaire at 6 months)
- Number of participants that will keep their new sleep-timings.(6 months)
研究者
Katarina Danielsson
M.D. Ph.D student.
Uppsala University