Music to Improve Sleep Quality in Adults With Depression and Insomnia

Not Applicable

Completed

• Conditions: Depression; Insomnia
• Interventions: Other: Music Intervention

• Registration Number: NCT03676491
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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

1. improving sleep quality,

2. reducing symptoms of depression and

3. 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

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.

Study Timeline

• Study Start: 2018-05-23
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-18
• Status Verified: 2020-12
• Primary Completion: 2020-12-23
• Study Completion: 2020-12-23
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Music Intervention	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

Primary Outcome Measures

Name	Time	Method
Sleep Quality - subjective	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

Secondary Outcome Measures

Name	Time	Method
Sleep Quality - subjective	Change of sleep quality from baseline at 8 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.
Sleep Quality - objective	Change of sleep quality from baseline at 8 weeks	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.
Quality of life measuring subjective well-being	Change of quality of life from baseline at 8 weeks	The World Health Well-Being Index (WHO-5)
Symptoms of depression	Change of depression level from baseline at 8 weeks	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.
Quality of life measuring subjective psychological health, physical health, social relationships and environment.	Change of quality of life from baseline at 8 weeks	The World Health Organization Quality of Life (WHOQOL-Bref)

Trial Locations

Locations (1)

Unit for Depression, Psychiatry; 🇩🇰 Aalborg, Denmark