Music to Improve Sleep Quality in Adults With Depression and Insomnia: a Randomized Controlled Trial Using Mixed Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Sleep Quality - subjective
研究概览
简要总结
Insomnia is a common sleep disorder for patients with depression. This has a major impact on the quality of life for the individual.
The aim is to investigate, whether music intervention is effective in
- improving sleep quality,
- reducing symptoms of depression and
- improving quality of life
Participants use a sound pillow and selected music in the The Music Star app at home as a sleep aid in 4 weeks.
详细描述
Depression is a common health problem in Denmark with a prevalence for depression of 17-18%. Depression has serious personal and social consequence. Sleep disorders are common in patients with depression. Resolving sleep disturbances in depression may prevent worsening of symptoms and relapse.
Music listening is widely used as a sleep aid. A study from the Cochrane library shows consensus that music may be helpful to improve sleep quality in insomnia. It remains unclear if music listening is helpful to patients with depression as it is to a broader population.
A randomized controlled trial address the use of music as a supplementary treatment to improve sleep in depression.
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
- •Out patients in treatment for depression in psychiatry, Unit for Depression, Aalborg University Hospital.
- •ICD-10 diagnosis of unipolar depression F32 or F
- •Sleeping problems identified by HAM-D by a total score of 3 on sleep items 4-6, or a single score = 2 on at least one sleep item.
- •Following treatment standards according to national guidelines.(pharmacological treatment, psychotherapy, psycho education, Electro Convulsive Therapy).
- •4 weeks of treatment and/or in stabilized pharmacological treatment
排除标准
- •ICD-10 diagnosis of depression F32 or F33 and psychotic episodes
- •substance or alcohol abuse
- •sentence to treatment by law
- •restless legs syndrome
- •obstructive sleep apnoea or other organic sleep disorders
- •hearing loss
- •dislike of music
研究组 & 干预措施
Experimental Group
Music Intervention: Participants listen to music minimum 30 minutes at bedtime for a period of 4 weeks wearing accelerometer.
Participants are monitored for a 4 week follow up period wearing accelerometer
干预措施: Music Intervention (Other)
Waitlist Control Group
No intervention: Participants are monitored for a period of 4 weeks wearing accelerometer.
Participants are monitored for a 4 week follow up period wearing accelerometer.
结局指标
主要结局
Sleep Quality - subjective
时间窗: Change of sleep quality from baseline at 4 weeks
Questionnaire PSQI-DK on self reported sleep measuring subjective sleep quality, sleep latency, sleep duration, sleep disturbances, daytime dysfunctions and use of antidepressant agents
次要结局
- Sleep Quality - subjective(Change of sleep quality from baseline at 8 weeks)
- Sleep Quality - objective(Change of sleep quality from baseline at 8 weeks)
- Quality of life measuring subjective well-being(Change of quality of life from baseline at 8 weeks)
- Symptoms of depression(Change of depression level from baseline at 8 weeks)
- Quality of life measuring subjective psychological health, physical health, social relationships and environment.(Change of quality of life from baseline at 8 weeks)
- Sleep Quality - objective(Change of sleep quality from baseline at 4 weeks)
- Symptoms of depression(Change of depression level from baseline at 4 weeks)
- Quality of life measuring subjective well-being(Change of quality of life from baseline at 4 weeks)
- Quality of life measuring subjective psychological health, physical health, social relationships and environment.(Change of quality of life from baseline at 4 weeks)
研究者
Helle Nystrup Lund
Music Therapist, Ph.d. student
Aalborg University Hospital