Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma

Study Overview
=================
Brief Summary
-----------------
This study will use a systematic music therapy intervention on patients with mental illness trying to help them with their internalized stigma.

Detailed Description
-----------------
The primary objective of this study is to determine the effect of a systematic music therapy intervention on internalized stigma of mental illness. The secondary objective is to evaluate the potential for the treatment effect to vary across subject diagnostic categories. This study will also examine the ability of the treatment effect to persist after 3 weeks as an exploratory objective. Data collection will be conducted in the Acute Care Unit (ACU) of Hackensack Meridian Health Carrier Clinic (HMHCC) over a period of ten months. Subjects will be drawn from the pool of patients admitted to the HMHCC ACU during that time. Adults aged 18-65 with severe mental illness with a diagnosis of bipolar or a related disorder, depressive or anxiety disorder, or schizophrenia spectrum or other psychotic disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5 : 5th ed.; American Psychiatric Association, 2013), of prolonged duration with a significant degree of disability or social dysfunction (Ruggeri et al., 2000) are eligible to participate. Eligible participants must be able to provide informed consent as determined by the doctor.

Official Title
-----------------
The Effect of a Group Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma in Adult Psychiatric Inpatients in Acute Care

Conditions
-----------------
Mental Health Issues, Bipolar Disorder, Depressive, Schizophrenia Spectrum and Other Psychotic Disorders, Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Group Music Therapy Advocacy Recording Intervention (MTAR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the HMHCC ACU Able to read and comprehend the ISMI questionnaire, provide informed consent, With a severe mental illness of prolonged duration with a significant degree of disability or social dysfunction Exclusion Criteria: Patients on S1 status (1:1 patient observation) or isolation protocol Evidence of organic brain disease, severe acute symptomatology, hearing deficit, and intellectual disability.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pseudo cluster randomized controlled design (Borm et al., 2005) will take advantage of the unit's two separate residential areas
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>The intervention consists of a sequence of five music therapy song-writing and recording groups, one per day. Internalized stigma will be assessed within 3 days of admission (pretest/baseline), at ten days (posttest), and at 3 weeks from baseline (follow-up), using the Internalized Stigma of Mental Illness Inventory. | Behavioral: Group Music Therapy Advocacy Recording Intervention (MTAR)<br>* Music Therapy Advocacy Recording Intervention (MTAR) is a sequence of group music therapy song-writing and recording sessions framed as a mental health awareness project to be shared with the general public.<br>|
| No Intervention: Control Group<br>Access to standard of care services that include several groups per day focused on topics of coping skills, mindfulness, journaling, creative arts, wellness recovery, recreation, and at least one music therapy group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Internalized Stigma of Mental Illness Inventory (ISMI) score between pre and post MTAR | The Internalized Stigma of Mental Illness Inventory will be administered before and after the MTAR intervention and the change in the score will be reported. Primary outcome will be reported only for the treatment arm. The internalized stigma of mental illness inventory is a 29 item questionnaire. Items are scored on a 1-4 scale, with the total scale score calculated as a sum of the items then dividing by the total number of answered items. | Post MTAR intervention (day 8-10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ISMI score based on diagnostic category | Change in the Internalized Stigma of Mental Illness Inventory (ISMI) score between pre and post MTAR across subject diagnostic categories. ISMI scores will be compared between subjects with no diagnosis or diagnosed with schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, depressive disorders, and anxiety disorders, as classified by the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5; American Psychiatric Association, 2013). The internalized stigma of mental illness inventory is a 29 item questionnaire. Items are scored on a 1-4 scale, with the total scale score calculated as a sum of the items then dividing by the total number of answered items. | Post MTAR intervention (day 8-10) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internalized stigma, Music therapy, Music Therapy Advocacy Recording Intervention, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Health Issues