Music to Improve Sleep Quality in Adults With Depression and Insomnia

NCT03676491 | Completed DMC

• 1 other identifier: N-20170055
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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. 1.improving sleep quality,
2. 2.reducing symptoms of depression and
3. 3.improving quality of life

Conditions

Insomnia; Depression

Keywords

music; depression; sleep disturbances; insomnia; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  Change of sleep quality from baseline at 4 weeks

Secondary Outcomes (9)

• Sleep Quality - subjective

  Change of sleep quality from baseline at 8 weeks

• Sleep Quality - objective

  Change of sleep quality from baseline at 4 weeks

• Sleep Quality - objective

  Change of sleep quality from baseline at 8 weeks

• Symptoms of depression

  Change of depression level from baseline at 4 weeks

• Symptoms of depression

  Change of depression level from baseline at 8 weeks

Other Outcomes (1)

• Duration of music intervention

  4 week music intervention period

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Waitlist Control Group

NO INTERVENTION

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.

Interventions

Music Intervention OTHER

Music intervention

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• weeks of treatment and/or in stabilized pharmacological treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Health Research Foundation: collaborator
• The Obel Family Foundation: collaborator
• Aase & Ejnar Danielsens Foundation: collaborator

Study Sites (1)

Unit for Depression, Psychiatry

Aalborg, 9000, Denmark

Location

Related Publications (5)

• Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65 Suppl 16:27-32.

  PMID: 15575802 BACKGROUND

• 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.

  PMID: 26270746 BACKGROUND

• 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.

  PMID: 36000763 DERIVED

• 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.

  PMID: 35697087 DERIVED

• 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.

  PMID: 32245512 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Soeren Risom Kristensen, Professor

  Aalborg University, Doctoral School in Medicine, biomedical science and technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Music Therapist, Ph.d. student

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 18, 2018
• Study Start: May 23, 2018
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

DK (1)