NCT06733883

Brief Summary

The goal of this clinical trial is to examine the effects of a music therapy program in adolescents aged 13-18 years old with emotional difficulties, primarily depression and possibly concurrent diagnoses of anxiety. The main questions are:

  • What recruitment methods, barriers, and facilitators influence study participation among adolescents with emotional difficulties receiving music therapy in the present study?
  • Does music therapy contribute to a significant reduction in depression and anxiety symptoms, inclusive concomitant symptoms?
  • How do adolescents with emotional disorders perceive participation in music therapy, and how do they articulate its potential impacts on their health and well-being? Participants will be invited to participate in a music therapy program, in addition to standard treatment given (TAU). They meet individually in the clinic with a professional music therapist once a week over a period of ten weeks. They will also do musical home exercises between the sessions. Psychiatric interviews and clinical assessments will be conducted before treatment. Assessments and questionnaires will be performed right after the therapy program and three months after ended therapy. There will also be conducted qualitative interviews with a subgroup of the participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
26mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Oct 2023Jun 2028

Study Start

First participant enrolled

October 9, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

December 13, 2024

Status Verified

January 1, 2024

Enrollment Period

4.6 years

First QC Date

January 8, 2024

Last Update Submit

December 10, 2024

Conditions

Keywords

Music therapyAdolescentsEmotional dysregulationDepression

Outcome Measures

Primary Outcomes (2)

  • Beck's Depression Inventory

    The inventory is a 21-item self-report instrument used to measure the severity of depression. The minimum score is zero, indicating no symptoms or signs of depression, while the maximum score is 63, indicating severe depression.

    The inventory will be assessed at three time points: at baseline, one week post-intervention, and three months post-intervention

  • The Satisfaction Scale

    Participants provide feedback on their experience with participating in the study by indicating their level of agreement with six statements, rated on a scale from 1 to 5, where 1 signifies 'strongly disagree' and 5 signifies 'strongly agree' (see attached questionnaire). The minimum score is six, indicating no satisfaction, while the maximum score is 30, indicating high degree of satisfaction.

    The scale will be used at two time points: one week post-intervention, three months, post-intervention

Secondary Outcomes (6)

  • Spence Children's Anxiety Scale

    The scale will be used at three time points: at baseline, one week post-intervention, and three months post-intervention

  • Inventory of Life Quality in Children and Adolescents

    The inventory will be assessed at three time points: at baseline, one week post-intervention, and three months post-intervention.

  • Suicidal Ideation Questionnaire

    The questionnaire will be used at three time points: at baseline, one week post-intervention, and three months post-intervention

  • Deliberate Self-Harm Inventory

    The inventory will be assessed at three time points: baseline, one week post-intervention, and three months post-intervention

  • Difficulties in Emotion Regulation Scale

    The scale will be used at three time points: at baseline, one week post-intervention, and three months post-intervention

  • +1 more secondary outcomes

Study Arms (1)

Music therapy

EXPERIMENTAL

All participants get 10 sessions of music therapy, each lasting for 45 to 60 minutes.

Other: psychotherapy

Interventions

Music therapy

Music therapy

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • adolescents 13 to 18 years
  • emotional difficulties

You may not qualify if:

  • autism spectrum disorder
  • mental retardation
  • severe depressive episode combined with high suicidal risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university hospital

Oslo, Nydalen, 0424, Norway

RECRUITING

Related Publications (28)

  • Aasen, H. (2001). An empirical investigation of depression symptoms: norms, psychometric characteristics, and factor structure of the Beck Depression Inventory II. Bergen: Det psykologiske fakultet, Universitetet i Bergen.

    BACKGROUND
  • Aalbers S, Fusar-Poli L, Freeman RE, Spreen M, Ket JC, Vink AC, Maratos A, Crawford M, Chen XJ, Gold C. Music therapy for depression. Cochrane Database Syst Rev. 2017 Nov 16;11(11):CD004517. doi: 10.1002/14651858.CD004517.pub3.

    PMID: 29144545BACKGROUND
  • Bakken, A. & Osnes, S.M. (2021). Ung i Oslo 2021. Ungdomsskolen og videregående skole. NOVA Rapport 9121. Oslo: NOVA, OsloMet

    BACKGROUND
  • Belski N, Abdul-Rahman Z, Youn E, Balasundaram V, Diep D. Review: The effectiveness of musical therapy in improving depression and anxiety symptoms among children and adolescents - a systematic review. Child Adolesc Ment Health. 2022 Nov;27(4):369-377. doi: 10.1111/camh.12526. Epub 2021 Dec 1.

    PMID: 34854208BACKGROUND
  • Erkkila J, Brabant O, Hartmann M, Mavrolampados A, Ala-Ruona E, Snape N, Saarikallio S, Gold C. Music Therapy for Depression Enhanced With Listening Homework and Slow Paced Breathing: A Randomised Controlled Trial. Front Psychol. 2021 Feb 16;12:613821. doi: 10.3389/fpsyg.2021.613821. eCollection 2021.

    PMID: 33664693BACKGROUND
  • FHI. (2015, 11.05). Fakta om sosial støtte og ensomhet. Hentet 07.04 2020 fra https://www.fhi.no/fp/psykiskhelse/psykiskelidelser/sosial-stotte-og-ensomhet--- faktaar/ FHI. (2018, 14.05).

    BACKGROUND
  • Gross, J. J. (2013). Emotion Regulation: Conceptual Foundations. In J. J. Gross (Ed.), Handbook of Emotion Regulation, Second Edition (Second edition. ed., pp. 3-22): Guilford Publications.

    BACKGROUND
  • Grøholt B og Sund AM. (2019). Depressive lidelser. Veileder i barne- og ungdomspsykiatri. Den norske legeforeningen

    BACKGROUND
  • Geretsegger M, Mossler KA, Bieleninik L, Chen XJ, Heldal TO, Gold C. Music therapy for people with schizophrenia and schizophrenia-like disorders. Cochrane Database Syst Rev. 2017 May 29;5(5):CD004025. doi: 10.1002/14651858.CD004025.pub4.

    PMID: 28553702BACKGROUND
  • Hendricks CB, Robinson B, Bradley B, et al. (1999). Using music techniques to treat adolescent depression. J. Humanist. Couns. Educ Dev. 38: 39-46.

    BACKGROUND
  • Helsedirektoratet (2013). Nasjonal faglig retningslinje for utredning, behandling og oppfølging av personer med psykoselidelser.

    BACKGROUND
  • Ishak M, Herrera N, Martin C, et al.(2021). Music Therapy for Depression in Adolescents: A Systematic Review of Randomized Controlled Trials. Int J Psychiatr Res. 2021; 4(1): 1-5.

    BACKGROUND
  • Johns, U. (2008). " Å bruke tiden - hva betyr egentlig det?" Tid og relasjon - et intersubjektivt perspektiv. NMH-publikasjoner; 2008:3. Skriftserie fra Senter for musikk og helse;1. Norges musikkhøgskole

    BACKGROUND
  • Jozefiak T, Larsson B, Wichstrom L. Changes in quality of life among Norwegian school children: a six-month follow-up study. Health Qual Life Outcomes. 2009 Feb 4;7:7. doi: 10.1186/1477-7525-7-7.

    PMID: 19193211BACKGROUND
  • Kaufman J, Birmaher B, Axelson D, Pereplitchikova F, Brent D, Ryan N. (2016). The KSADS-PL DSM-5. Kennedy Krieger Institute. Baltimore.

    BACKGROUND
  • Monsen, J. T., Solbakken, O. A. (2013). Affektintegrasjon og nivåer av mental representasjon: Fokus for terapeutisk intervensjon i Affektbevissthetsmodellen. Tidsskrift for norsk psykologforening, 50, 8, 740-752.

    BACKGROUND
  • Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.

    PMID: 444788BACKGROUND
  • Norsk pasientregister (NPR) 2019. Helsedirektoratet.

    BACKGROUND
  • Porter ME, Larsson S, Lee TH. Standardizing Patient Outcomes Measurement. N Engl J Med. 2016 Feb 11;374(6):504-6. doi: 10.1056/NEJMp1511701. No abstract available.

    PMID: 26863351BACKGROUND
  • Reynolds R (1987). Suicidal Ideation Questionnaire: Professional manual. Psychological Assessment Resources Inc.

    BACKGROUND
  • Rolvsjord, R. (2010). Resource oriented music therapy in mental health care. Barcelona Publishers.

    BACKGROUND
  • Ruud, E. (2008). Et humanistisk perspektiv på musikkterapi. Norges musikkhøgskole Skriftserie fra Senter for musikk og helse;1. NMH-publikasjoner;2008:3

    BACKGROUND
  • Ruud, E. (2020) Towards a Sociology of music therapy: Musicking as a cultural Immunogen. Barcelona publishers.

    BACKGROUND
  • Sansone RA, Sansone LA. Measuring self-harm behavior with the self-harm inventory. Psychiatry (Edgmont). 2010 Apr;7(4):16-20.

    PMID: 20508804BACKGROUND
  • Trondalen, G. (2016). Relational Music Therapy: An Intersubjective Perspective. Dallas, TX: Barcelona Publishers.

    BACKGROUND
  • WHO (2005). Promoting Mental Health, Concepts; Emerging EvidencePractice. A Report of the World Health Organization, Department of Mental Health and Substance Abuse in collaboration with the Victorian Health Promotion Foundation and The University of Melbourne.

    BACKGROUND
  • Saarikallio S, Gold C, McFerran K. Development and validation of the Healthy-Unhealthy Music Scale. Child Adolesc Ment Health. 2015 Nov;20(4):210-217. doi: 10.1111/camh.12109. Epub 2015 May 18.

    PMID: 26726295BACKGROUND
  • Bellapu, A., Chemmanoor, S., Hu, M., Kim, N., & Clark, C. (2021). Journal of Student Research, 10(4). https://doi.org/10.47611/jsrhs.v10i4.2385)

    BACKGROUND

MeSH Terms

Conditions

Depressive DisorderDepression

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Anne M Myhre, MD Phd

    Oslo UH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne M Myhre, MD Phd

CONTACT

Kristin R Øvergaard, MD Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Music therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2024

First Posted

December 13, 2024

Study Start

October 9, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

December 13, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in the publication of the Phd will be shared within the reseach-group after they are deidentified. A coding list is available for the PI in the study. The Phd student can also see and add participants to the study.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The data will become available from start of the inclusion to the study is completed.
Access Criteria
The PI is responsible for the data. Members of the reseachgroup have access to the data and are approved by the Regional Ethical Committee.

Locations