Music to Improve Sleep Quality in Adults With Depression and Insomnia (MUSTAFI)
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| ClinicalTrials.gov Identifier: NCT03676491 |
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Recruitment Status :
Completed
First Posted : September 18, 2018
Last Update Posted : December 31, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Insomnia Depression | Other: Music Intervention | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| 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. |
| 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 : | December 23, 2020 |
| Actual Study Completion Date : | December 23, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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. |
- Sleep Quality - subjective [ Time Frame: 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
- Sleep Quality - subjective [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Change of quality of life from baseline at 8 weeks ]The World Health Organization Quality of Life (WHOQOL-Bref)
- Duration of music intervention [ Time Frame: 4 week music intervention period ]log file data on duration of music intervention
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676491
| Denmark | |
| Unit for Depression, Psychiatry | |
| Aalborg, Denmark, 9000 | |
| Study Director: | Soeren Risom Kristensen, Professor | Aalborg University, Doctoral School in Medicine, biomedical science and technology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Helle Nystrup Lund, Music Therapist, Ph.d. student, Aalborg University Hospital |
| ClinicalTrials.gov Identifier: | NCT03676491 |
| Other Study ID Numbers: |
N-20170055 N-20170055 ( Registry Identifier: 296056 ) |
| First Posted: | September 18, 2018 Key Record Dates |
| Last Update Posted: | December 31, 2020 |
| Last Verified: | December 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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music depression sleep disturbances insomnia quality of life |
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Sleep Initiation and Maintenance Disorders Depression Depressive Disorder Behavioral Symptoms Mood Disorders |
Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |