Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma

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

This study will use a systematic music therapy intervention on patients with mental illness trying to help them with their internalized stigma.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar Disorder; Anxiety Disorder; Mental Health Issues; Depressive
• Intervention / Treatment: Behavioral: Group Music Therapy Advocacy Recording Intervention (MTAR)

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Belle Mead, New Jersey, United States, 08502
      • Carrier Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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); 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.
No Intervention: Control Group; 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)

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: American Music Therapy Association
• Investigators: Principal Investigator: Zachary D Fischer, PhD, MT-BC, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Music therapy; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Health Issues; Internalized stigma; Music Therapy Advocacy Recording Intervention
• Additional Relevant MeSH Terms: Mood Disorders; Bipolar and Related Disorders; Schizophrenia; Psychotic Disorders; Anxiety Disorders; Mental Disorders; Bipolar Disorder; Schizophrenia Spectrum and Other Psychotic Disorders
• Other Study ID Numbers: Pro2022-0570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No