MUSTAFI: Music to Improve Sleep Quality in Adults With Depression and Insomnia

Sponsor

Aalborg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03676491

Collaborator

Health Research Foundation (Other), The Obel Family Foundation (Other), Aase & Ejnar Danielsens Foundation (Other)

112

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Depression	Other: Music Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 23, 2018

Actual Primary Completion Date :

Dec 23, 2020

Actual Study Completion Date :

Dec 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: Music Intervention Music intervention
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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

Other: Music Intervention

Music intervention

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

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

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 4 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.
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.
Symptoms of depression [Change of depression level from baseline at 4 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.
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 well-being [Change of quality of life from baseline at 4 weeks]
The World Health Well-Being Index (WHO-5)
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)
Quality of life measuring subjective psychological health, physical health, social relationships and environment. [Change of quality of life from baseline at 4 weeks]
The World Health Organization Quality of Life (WHOQOL-Bref)
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)

Other Outcome Measures

Duration of music intervention [4 week music intervention period]
log file data on duration of music intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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