Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): study protocol for a randomized controlled trial

Helle Nystrup Lund, Inge Nygaard Pedersen, Søren Paaske Johnsen, Agnieszka M Heymann-Szlachcinska, Maryla Tuszewska, Gustav Bizik, Jens Ivar Larsen, Eszter Kulhay, Anelia Larsen, Bettina Grønbech, Helle Østermark, Heidi Borup, Jan Brink Valentin, Jan Mainz, Helle Nystrup Lund, Inge Nygaard Pedersen, Søren Paaske Johnsen, Agnieszka M Heymann-Szlachcinska, Maryla Tuszewska, Gustav Bizik, Jens Ivar Larsen, Eszter Kulhay, Anelia Larsen, Bettina Grønbech, Helle Østermark, Heidi Borup, Jan Brink Valentin, Jan Mainz

Abstract

Background: Insomnia is a common sleep disorder for adults with depression, with major impact on their quality of life. Previous trials suggest that listening to music may be helpful in the treatment of sleep disturbances in healthy populations, including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented.

Objective: To examine the efficacy of music listening on sleep quality, symptoms of depression, and quality of life in adults with depression-related insomnia.

Method: A single-center randomized controlled trial (RCT) in a two-arm parallel-group design is conducted and reported according to the CONSORT guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish clinical guidelines in an outpatient psychiatry unit. The experimental group listens to music for a minimum of 30 minutes at bedtime for 4 weeks.

Discussion: This trial will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression-related insomnia. This study will provide novel knowledge concerning music medicine as an evidence-based treatment for depression.

Trial registration: Clinicaltrials.gov. ID NCT03676491, registered on 19 September 2018.

Keywords: Music; depression; insomnia; sleep.

Conflict of interest statement

HNL is co-inventor of the Music Star app and has economic interest in the research due to ownership and sales of the Music Star app. The Music Star app is commercialized in collaboration with the company AudioCura, which delivers sound equipment to Aalborg University Hospital. The company has no influence on the study. The inventors HNL and LRB are music therapists employed at Aalborg University Hospital of whom only HNL (the first author) is a member of the research group. The inventors follow the ethical principles by the Danish Union of Music Therapists (Dansk Musikterapeutforening). HNL is responsible for data collection. All data are entered in REDCAP by a research assistant independently of the first author. A statistician is responsible for data analysis. The authors INP, SPJ, AMH-S, MT, GB, JIL, EK, AL, HØ, BG, HB, JBV, and JM declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Selected solution-enabling music listening. A sound pillow is a pillow with small internal speakers. The sound pillow features a port through which to connect a player (Mp3/iPad/mobile phone). The user selects the music on the player. (Photo courtesy of Sound Oasis)
Fig. 2
Fig. 2
The Music Star is an app developed for iPad to select music from a number of specially designed playlists. Each playlist is represented by a colored triangle forming a star. (Photo courtesy of Musikstjernen IVS)
Fig. 3
Fig. 3
Flow diagram of MUSTAFI phases, including enrolment, allocation, follow-up, and data analysis
Fig. 4
Fig. 4
Schedule of enrolment, interventions, and assessments (Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) flow chart)

References

    1. The World Health Organization. The global burden of disease: 2004 update Part 4. Glob Burd Dis 2004 Updat. 2008;40–51.
    1. Sundhedsstyrelsen. National Klinisk Retningslinje for Unipolar depression. 2016..
    1. Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, et al. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017;26:675–700. doi: 10.1111/jsr.12594.
    1. Chen J, Liu JH, Xu N, Liang ZH, Xu ZH, Xu SJ, et al. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial. Trials. 2013;14:2. doi: 10.1186/1745-6215-14-2.
    1. Trahan T, Durrant SJ, Müllensiefen D, Williamson VJ. The music that helps people sleep and the reasons they believe it works: a mixed methods analysis of online survey reports. PLoS One. 2018;13:1–19. doi: 10.1371/journal.pone.0206531.
    1. Jespersen K, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015;8:CD010459.
    1. Chan MF, Wong ZY, Thayala NV. A systematic review on the effectiveness of music listening in reducing depressive symptoms in adults. JBI Libr Syst Rev. 2010;8:1242–1287. doi: 10.11124/jbisrir-2010-163.
    1. Short A, Ahern N. Evaluation of a systematic development process: relaxing music for the emergency department. Aust J Music Ther. 2009;20:3–26.
    1. Bonde LO. Playlists and patients’ preferences: comments on short & aherns article “evaluation of a systematic development process: relaxing music for the emergency department”. Aust J Music Ther. 2008;20:27–29.
    1. Bradt J, Dileo C, Grocke D. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2010;12:CD006902.
    1. MacDonald R, Kreutz G, Mitchell L. What is music, health and wellbeing and why is it important. Music Heal Wellbeing. 2012:2–12.
    1. Garbarino S, Lanteri P, Durando P, Magnavita N, Sannita WG. Co-morbidity, mortality, quality of life and the healthcare/welfare/social costs of disordered sleep: a rapid review. Int J Environ Res Public Health. 2016;13:E831. doi: 10.3390/ijerph13080831.
    1. Lund HN, Pedersen IN. Pilot project: sound pillow treatment to improve sleep quality for patients with depression or bipolar diagnosis with sleeping problems. 24th Eur Congr Psychiatry, EPA 2016 Madrid Spain. Elsevier Masson SAS; 2016;33:S80.
    1. Grocke DE, Wigram T. Receptive methods in music therapy: techniques and clinical applications for music therapy clinicians, educators, and students. London: Jessica Kingsley Publishers; 2007.
    1. Altmann DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134(8):663–694. doi: 10.7326/0003-4819-134-8-200104170-00012.
    1. Bradt J. Randomized controlled trials in music therapy: Guidelines for design and implementation. J Music Ther. 2012;49:120–149. doi: 10.1093/jmt/49.2.120.
    1. Deshmukh AD, Sarvaiya AA, Nayak AS. Effect of Indian classical music on quality of sleep in depressed patients: a randomized controlled trial. Nord J Music Ther. 2009;18:70–78. doi: 10.1080/08098130802697269.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. Liu XC, Tang MQHL, et al. Reliability and validity of the Pittsburgh Sleep Quality Index. Chinese J Psychiatry. 1996;29:103–107.
    1. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56–62. doi: 10.1136/jnnp.23.1.56.
    1. Bobo WW, Angelero GC, Jenkins G, Hall-Flavin DK, Weinshilboum R, Biernacke JM. Validation of the 17-item Hamilton depression rating scale definition of response for adults with major depressive disorder using equipercentile liniking to clinical global impression scale ratings: analysis of pharmacogenomic research network antidepress. Hum Psychopharmacol. 2016;40:3070–3077.
    1. Topp CW, Østergaard SD, Søndergaard SBP. The WHO-5 wellbeing index: a stystematic review of the literature. Psychother Psychosom. 2015;84:167–176. doi: 10.1159/000376585.
    1. Lund HN, Bertelsen LR, Bonde LO. Sound and music interventions in psychiatry at Aalborg University. Sound Eff. 2016;6:48–68.
    1. Van Hees VT, Sabia S, Anderson KN, Denton SJ, Oliver J, Catt M, et al. A novel, open access method to assess sleep duration using a wrist-worn accelerometer. PLoS One. 2015;10:1–13.
    1. Warja M, Bonde LO. Music as co-therapist: towards a taxonomy of music in therapeutic music and imagery work. Music Med. 2014;6:16–27.
    1. Li G, Taljaard M, Van Den Heuvel ER, Levine MAH, Cook DJ, Wells GA, et al. An introduction to multiplicity issues in clinical trials: the what, why, when and how. Int J Epidemiol. 46:746–55.
    1. Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65:27–32. doi: 10.4088/JCP.v65n0411.
    1. Jindal RD, Thase ME. Treatment of insomnia associated with clinical depression. Sleep Med Rev. 2004;8:19–30. doi: 10.1016/S1087-0792(03)00025-X.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する