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Music to Improve Sleep Quality in Adults With Depression and Insomnia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03676491
Acronym
MUSTAFI
Enrollment
112
Registered
2018-09-18
Start date
2018-05-23
Completion date
2020-12-23
Last updated
2020-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Insomnia

Keywords

music, depression, sleep disturbances, insomnia, quality of life

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.

Interventions

OTHERMusic Intervention

Music intervention

Sponsors

Health Research Foundation
CollaboratorOTHER
The Obel Family Foundation
CollaboratorUNKNOWN
Aase & Ejnar Danielsens Foundation
CollaboratorUNKNOWN
Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep Quality - subjectiveChange of sleep quality from baseline at 4 weeksQuestionnaire PSQI-DK on self reported sleep measuring subjective sleep quality, sleep latency, sleep duration, sleep disturbances, daytime dysfunctions and use of antidepressant agents

Secondary

MeasureTime frameDescription
Sleep Quality - subjectiveChange of sleep quality from baseline at 8 weeksQuestionnaire 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 - objectiveChange of sleep quality from baseline at 4 weeksAccelerometer 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-beingChange of quality of life from baseline at 4 weeksThe World Health Well-Being Index (WHO-5)
Quality of life measuring subjective psychological health, physical health, social relationships and environment.Change of quality of life from baseline at 4 weeksThe World Health Organization Quality of Life (WHOQOL-Bref)
Symptoms of depressionChange of depression level from baseline at 4 weeksThe Hamilton Depression Rating Scale (HAM-D17). The scale consist of 17 items. Total score range is 0-52. Higher numbers represent more severe symptoms.

Other

MeasureTime frameDescription
Duration of music intervention4 week music intervention periodlog file data on duration of music intervention

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026