Music to Improve Sleep Quality in Adults With Depression and Insomnia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Music to Improve Sleep Quality in Adults With Depression and Insomnia: a Randomized Controlled Trial Using Mixed Methods

Conditions
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Insomnia, Depression

Intervention / Treatment
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* Other: Music Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out patients in treatment for depression in psychiatry, Unit for Depression, Aalborg University Hospital. ICD-10 diagnosis of unipolar depression F32 or F33. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design is an explanatory mixed methods design in two parts. The first part is a two-arm parallel group, single center randomized controlled trial (n=120). Experimental group and waitlist control group receive standard treatment according to national guidelines. The experimental group use a sound pillow and The Music Star App at bedtime as a sleep aid in 4 weeks.The second part is an interview study (n=4). Qualitative data from a semi-structured interview on the use of music and sleep are used to discuss findings from the RCT.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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 | Other: Music Intervention<br>* Music intervention<br>|
| No Intervention: Waitlist Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality - subjective | Questionnaire PSQI-DK on self reported sleep measuring subjective sleep quality, sleep latency, sleep duration, sleep disturbances, daytime dysfunctions and use of antidepressant agents | Change of sleep quality from baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality - subjective | Questionnaire PSQI-DK on self reported sleep measuring subjective sleep quality, sleep latency, sleep duration, sleep disturbances, daytime dysfunctions and use of antidepressant agents. | Change of sleep quality from baseline at 8 weeks | 
| Sleep Quality - objective | Accelerometer Axivity Ax3 data logger carried as a hand wrist bracelet at night. A sleep analysis function by a generic algorithm provide data on sleep estimates. | Change of sleep quality from baseline at 4 weeks | 
| Sleep Quality - objective | Accelerometer Axivity Ax3 data logger carried as a hand wrist bracelet at night. A sleep analysis function by a generic algorithm provide data on sleep estimates. | Change of sleep quality from baseline at 8 weeks | 
| Symptoms of depression | The Hamilton Depression Rating Scale (HAM-D17). The scale consist of 17 items. Total score range is 0-52. Higher numbers represent more severe symptoms. | Change of depression level from baseline at 4 weeks | 
| Symptoms of depression | The Hamilton Depression Rating Scale (HAM-D17). The scale consist of 17 items. Total score range is 0-52. Higher numbers represent more severe symptoms. | Change of depression level from baseline at 8 weeks | 
| Quality of life measuring subjective well-being | The World Health Well-Being Index (WHO-5) | Change of quality of life from baseline at 4 weeks | 
| Quality of life measuring subjective well-being | The World Health Well-Being Index (WHO-5) | Change of quality of life from baseline at 8 weeks | 
| Quality of life measuring subjective psychological health, physical health, social relationships and environment. | The World Health Organization Quality of Life (WHOQOL-Bref) | Change of quality of life from baseline at 4 weeks | 
| Quality of life measuring subjective psychological health, physical health, social relationships and environment. | The World Health Organization Quality of Life (WHOQOL-Bref) | Change of quality of life from baseline at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music, depression, sleep disturbances, insomnia, quality of life