Clinical trial NCT06733883: Music Therapy for Adolescents with Emotional Difficulties
Official title: "I've Got the Music in Me." Music Therapy for Adolescents with Emotional Difficulties: a Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder
Emotional Dysregulation
Keywords: Music therapy
Adolescents
Emotional dysregulation
Depression
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Academy of Music
First posted: 2024-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Music therapy
Primary purpose: TREATMENT

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.

Considering the reviewed literature and the findings from the pilot study, the following research questions will be explored:

1. What recruitment methods, barriers, and facilitators influence study participation among adolescents with emotional difficulties receiving music therapy in the present study?
2. Does music therapy contribute to a significant reduction in depression and anxiety symptoms, including concomitant symptoms?
3. 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?

Method

The study employs a single-arm repeated measures design, integrating both quantitative and qualitative data collection methods. It is conducted in collaboration between The Norwegian Academy of Music and Oslo University Hospital (OUH) and has received approval from the Regional Ethical Committee (REC) and the Patient Protection Representative at OUH.

20 adolescents aged 13 to 18 years, diagnosed with emotional disorders such as depression and/or anxiety, will be recruited from a child and adolescent outpatient unit in eastern Norway. They will receive standard treatment, including cognitive therapy potentially supplemented with psychopharmacological interventions, in addition to music therapy.

Participants will be referred to the study via two potential pathways. First, participants already receiving treatment at the clinic, who may require supplementary interventions to verbal therapy, may be referred by their current therapist to the music therapist. Alternatively, team leaders will identify new patients suitable for the study. Based on the diagnostic assessments, adolescents diagnosed with depressive episodes, anxiety, or in combination with other psychiatric disorders will be invited to supplement their standard treatment with music therapy. Exclusion criteria include diagnoses of autism spectrum disorders or intellectual disabilities, as well as severe depressive episodes and high suicidal risk, given that these conditions require more intensive care.

The music therapy program comprises ten weekly individual sessions. The initial session will include an introductory conversation to assess participants' musical preferences, resources, and history. Each session will last 45 to 60 minutes and will include warm-up exercises involving stretching, vocalization, and breathing techniques, followed by active music therapy with reproduction of popular music. Sessions will conclude with music listening and creation of a playlist for home listening. The therapy will be based on relational, humanistic and resource-oriented approaches to music therapy.

Prior to inclusion in the study, potential participants will be screened by a specialist in child and adolescent psychiatry using KIDDIE-SADS (Schedule for Affective Disorders and Schizophrenia) to ensure appropriateness and accuracy of their diagnoses for the study.

Data will be collected at three time points: at baseline, within one week following the completion of the music therapy, and at follow-up three months later.

The quantitative assessment will utilize the following measures:

* Beck's Depression Inventory (BDI-II) to assess depressive symptoms.
* The Multidimensional Anxiety Scale for Children (MASC) to evaluate anxiety symptoms.
* The Inventory of Life Quality (ILC) to measure quality of life.
* The Suicidal Ideation Questionnaire (SIQ-JR) to assess suicidal ideation.
* The Self-Harm Inventory (SHI) to assess self-harm behaviors.
* The Difficulties in Emotion Regulation Scale (DERS) to measure difficulties in emotional regulation.
* The Healthy-Unhealthy Music Scale (HUMS) to investigate the relationship between music and emotional experiences.

The qualitative assessment will utilize the following methods:

All participants will be interviewed within one week after the music therapy intervention is concluded, and at follow-up three months later. During the interviews, conducted by the music therapist, participants will be encouraged to provide feedback on the music therapy program, suggest improvements, and reflect on the therapy's impact on their health and behavior. These insights will contribute to the development of hypotheses and models to understand the mechanisms by which music therapy benefits this population and enhance well-being.

These interviews will be subjected to an inductive thematic analysis, where the goal is to gain deeper insight into the participants' experiences with the music therapy program.

Results

The findings of the study will be disseminated through publications in international peer-reviewed journals.

Ethics

Several ethical aspects, such as informed consent, confidentiality, and the protection of participant data, require careful consideration. Informed consent will be obtained through specifically designed forms; one for the participants aged 16 and above, who can provide their own consent, and another for the parents of participants under 16.

It is imperative to communicate to all participants their right to withdraw from the study at any stage, including during the course. All data and sensitive information must be securely stored in locked cabinets. Record-keeping will be conducted using an electronic journal system for Norwegian hospitals (DIPS), the computer system employed by the child and adolescent outpatient unit, while collected data will be stored in MedInsight and coded to ensure confidentiality. The balance between potential benefits and harms must be carefully considered when involving children in research, particularly in relation to the research theme. In this study, participants will engage in music activities and conversations, designed to promote mastery, curiosity, and highlight the participants' resourses. The research has the potential to benefit children and young people receiving treatment at the child and adolescent's outpatient unit, should the findings support the recommendation of music therapy as a treatment option.

The study will guarantee a safe environment for all participants. A crisis management plan outlining procedures to be followed if a participant expresses intent to harm themselves or others, will be established. Continuous collaboration with the responsible practitioner will be maintained throughout the data collection.

Eligibility criteria: Inclusion criteria:

* adolescents 13 to 18 years
* emotional difficulties

Exclusion criteria:

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

Primary outcomes:
measure: Beck's Depression Inventory
timeFrame: The inventory will be assessed at three time points: at baseline, one week post-intervention, and three months post-intervention
measure: The Satisfaction Scale
timeFrame: The scale will be used at two time points: one week post-intervention, three months, post-intervention
Secondary outcomes:
measure: Spence Children's Anxiety Scale
timeFrame: The scale will be used at three time points: at baseline, one week post-intervention, and three months post-intervention
measure: Inventory of Life Quality in Children and Adolescents
timeFrame: The inventory will be assessed at three time points: at baseline, one week post-intervention, and three months post-intervention.
measure: Suicidal Ideation Questionnaire
timeFrame: The questionnaire will be used at three time points: at baseline, one week post-intervention, and three months post-intervention
measure: Deliberate Self-Harm Inventory
timeFrame: The inventory will be assessed at three time points: baseline, one week post-intervention, and three months post-intervention
measure: Difficulties in Emotion Regulation Scale
timeFrame: The scale will be used at three time points: at baseline, one week post-intervention, and three months post-intervention
measure: Healthy-Unhealthy Music Scale
timeFrame: The scale will be used at three time points: at baseline, one week post-intervention, and three months post-intervention
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital
state: Nydalen
Study officials:
affiliation: Oslo UH
name: Anne M Myhre, MD Phd
role: PRINCIPAL_INVESTIGATOR
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