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Clinical Trials/NCT06733883
NCT06733883RecruitingNot Applicable

"I've Got the Music in Me." Music Therapy for Adolescents with Emotional Difficulties: a Clinical Study

Oslo University Hospital1 site in 1 country20 target enrollmentStarted: October 9, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
The Satisfaction Scale

Study Overview

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.

Detailed Description

Background Globally, emotional distress encompassing depression and anxiety is recognized as a predominant contributor to illness and disability among adolescents. These disorders substantially reduce adolescents' quality of life and account for a significant portion of disability-adjusted life years (DALYs). Existing treatment, which typically includes various forms of psychotherapy, possibly augmented with psychopharmaca, demonstrate only moderate efficacy. In Norway, over half of adolescents referred to specialized mental health services have depressive symptoms or ideation as their reason for referral. A substantial fraction of this population is diagnosed with depression either as the main condition or co-morbid with anxiety or other emotional difficulties.

Empirical evidence from a series of controlled intervention studies underscores the beneficial effects of music therapy on adults with depressive disorders, resulting in significant symptom alleviation and improved daily functionality. Additionally, research focusing on the impact of music therapy for adults with anxiety has demonstrated a significant reduction in symptoms.

However, research into the potential efficacy of music therapy for adolescents suffering from depression and anxiety remains relatively sparse. Preliminary studies indicate that music therapy may serve as a valuable intervention, reducing symptoms associated with these conditions. Nevertheless, existing research exhibits considerable variation in populations, methodologies, study designs, and outcome assessments. Furthermore, these studies incorporate both active and passive music therapy techniques, complicating the determination of optimal methodological approaches. Moreover, none of these studies have examined the supplementary benefits of integrating music therapy with standard treatment protocols for adolescents' depression, such as cognitive behavioral therapy (CBT) and pharmacotherapy.

Additionally, incidents of self-harm and suicidal ideation remain unreported in these studies. The present study aims to address these gaps in the existing literature and evaluate the potential applicability of positive outcomes observed in adult music therapy to adolescents with emotional disorders such as depression and anxiety.

A preliminary pilot study was conducted between autumn 2021 and June 2022, including five adolescents aged 13 - 18 years. This pilot study was designed to evaluate the recruitment and music therapy procedure for a larger-scale study. Among the three who completed the study, a significant reduction in depressive symptoms was observed from pre- to post-intervention. The participants reported enhanced coping mechanisms post-intervention, appreciating the therapeutic "time out" from challenging emotions and thoughts. Self-reports from the participants and feedback from therapists, indicated improved daily functioning during the music therapy intervention period.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •adolescents 13 to 18 years
  • •emotional difficulties

Exclusion Criteria

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

Arms & Interventions

Music therapy

Experimental

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

Intervention: psychotherapy (Other)

Outcomes

Primary Outcomes

The Satisfaction Scale

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

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.

Beck's Depression Inventory

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

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.

Secondary Outcomes

  • 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)
  • Healthy-Unhealthy Music Scale(The scale will be used at three time points: at baseline, one week post-intervention, and three months post-intervention)

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne Margrethe Myhre

Professor

Oslo University Hospital

Study Sites (1)

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