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

Primary Purpose

Insomnia, Depression

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Music Intervention
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring music, depression, sleep disturbances, insomnia, quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Unit for Depression, Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Waitlist Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
Quality of life measuring subjective well-being
The World Health Well-Being Index (WHO-5)
Quality of life measuring subjective well-being
The World Health Well-Being Index (WHO-5)
Quality of life measuring subjective psychological health, physical health, social relationships and environment.
The World Health Organization Quality of Life (WHOQOL-Bref)
Quality of life measuring subjective psychological health, physical health, social relationships and environment.
The World Health Organization Quality of Life (WHOQOL-Bref)

Full Information

First Posted
August 29, 2018
Last Updated
December 30, 2020
Sponsor
Aalborg University Hospital
Collaborators
Health Research Foundation, The Obel Family Foundation, Aase & Ejnar Danielsens Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03676491
Brief Title
Music to Improve Sleep Quality in Adults With Depression and Insomnia
Acronym
MUSTAFI
Official Title
Music to Improve Sleep Quality in Adults With Depression and Insomnia: a Randomized Controlled Trial Using Mixed Methods
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
December 23, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Health Research Foundation, The Obel Family Foundation, Aase & Ejnar Danielsens Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Depression
Keywords
music, depression, sleep disturbances, insomnia, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music Intervention
Intervention Description
Music intervention
Primary Outcome Measure Information:
Title
Sleep Quality - subjective
Description
Questionnaire PSQI-DK on self reported sleep measuring subjective sleep quality, sleep latency, sleep duration, sleep disturbances, daytime dysfunctions and use of antidepressant agents
Time Frame
Change of sleep quality from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Sleep Quality - subjective
Description
Questionnaire PSQI-DK on self reported sleep measuring subjective sleep quality, sleep latency, sleep duration, sleep disturbances, daytime dysfunctions and use of antidepressant agents.
Time Frame
Change of sleep quality from baseline at 8 weeks
Title
Sleep Quality - objective
Description
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.
Time Frame
Change of sleep quality from baseline at 4 weeks
Title
Sleep Quality - objective
Description
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.
Time Frame
Change of sleep quality from baseline at 8 weeks
Title
Symptoms of depression
Description
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.
Time Frame
Change of depression level from baseline at 4 weeks
Title
Symptoms of depression
Description
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.
Time Frame
Change of depression level from baseline at 8 weeks
Title
Quality of life measuring subjective well-being
Description
The World Health Well-Being Index (WHO-5)
Time Frame
Change of quality of life from baseline at 4 weeks
Title
Quality of life measuring subjective well-being
Description
The World Health Well-Being Index (WHO-5)
Time Frame
Change of quality of life from baseline at 8 weeks
Title
Quality of life measuring subjective psychological health, physical health, social relationships and environment.
Description
The World Health Organization Quality of Life (WHOQOL-Bref)
Time Frame
Change of quality of life from baseline at 4 weeks
Title
Quality of life measuring subjective psychological health, physical health, social relationships and environment.
Description
The World Health Organization Quality of Life (WHOQOL-Bref)
Time Frame
Change of quality of life from baseline at 8 weeks
Other Pre-specified Outcome Measures:
Title
Duration of music intervention
Description
log file data on duration of music intervention
Time Frame
4 week music intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soeren Risom Kristensen, Professor
Organizational Affiliation
Aalborg University, Doctoral School in Medicine, biomedical science and technology
Official's Role
Study Director
Facility Information:
Facility Name
Unit for Depression, Psychiatry
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
15575802
Citation
Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65 Suppl 16:27-32.
Results Reference
background
PubMed Identifier
26270746
Citation
Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015 Aug 13;2015(8):CD010459. doi: 10.1002/14651858.CD010459.pub2.
Results Reference
background
PubMed Identifier
36000763
Citation
Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.
Results Reference
derived
PubMed Identifier
35697087
Citation
Lund HN, Pedersen IN, Heymann-Szlachcinska AM, Tuszewska M, Bizik G, Larsen JI, Drago A, Kulhay E, Larsen A, Sorensen HO, Gronbech B, Bertelsen LR, Valentin JB, Mainz J, Johnsen SP. Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): randomized controlled trial. Nord J Psychiatry. 2023 Feb;77(2):188-197. doi: 10.1080/08039488.2022.2080254. Epub 2022 Jun 13.
Results Reference
derived
PubMed Identifier
32245512
Citation
Lund HN, Pedersen IN, Johnsen SP, Heymann-Szlachcinska AM, Tuszewska M, Bizik G, Larsen JI, Kulhay E, Larsen A, Gronbech B, Ostermark H, Borup H, Valentin JB, Mainz J. Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): study protocol for a randomized controlled trial. Trials. 2020 Apr 3;21(1):305. doi: 10.1186/s13063-020-04247-9.
Results Reference
derived

Learn more about this trial

Music to Improve Sleep Quality in Adults With Depression and Insomnia

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