Clinical trial NCT03676491: Music to Improve Sleep Quality in Adults With Depression and Insomnia
Official title: Music to Improve Sleep Quality in Adults With Depression and Insomnia: a Randomized Controlled Trial Using Mixed Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression
Keywords: music
depression
sleep disturbances
insomnia
quality of life
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Health Research Foundation
name: The Obel Family Foundation
name: Aase & Ejnar Danielsens Foundation
First posted: 2018-09-18
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sleep Quality - subjective
timeFrame: Change of sleep quality from baseline at 4 weeks
Secondary outcomes:
measure: Sleep Quality - subjective
timeFrame: Change of sleep quality from baseline at 8 weeks
measure: Sleep Quality - objective
timeFrame: Change of sleep quality from baseline at 4 weeks
measure: Sleep Quality - objective
timeFrame: Change of sleep quality from baseline at 8 weeks
measure: Symptoms of depression
timeFrame: Change of depression level from baseline at 4 weeks
measure: Symptoms of depression
timeFrame: Change of depression level from baseline at 8 weeks
measure: Quality of life measuring subjective well-being
timeFrame: Change of quality of life from baseline at 4 weeks
measure: Quality of life measuring subjective well-being
timeFrame: Change of quality of life from baseline at 8 weeks
measure: Quality of life measuring subjective psychological health, physical health, social relationships and environment.
timeFrame: Change of quality of life from baseline at 4 weeks
measure: Quality of life measuring subjective psychological health, physical health, social relationships and environment.
timeFrame: Change of quality of life from baseline at 8 weeks
Other outcomes:
measure: Duration of music intervention
timeFrame: 4 week music intervention period
Locations:
city: Aalborg
country: Denmark
facility: Unit for Depression, Psychiatry
Study officials:
affiliation: Aalborg University, Doctoral School in Medicine, biomedical science and technology
name: Soeren Risom Kristensen, Professor
role: STUDY_DIRECTOR
References:
citation: Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65 Suppl 16:27-32.
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.
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.
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.
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.