Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723328
• Other study ID #: Pro2022-0570
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: April 24, 2025

Study information

• Verified date: April 2023
• Source: Hackensack Meridian Health
• Contact: Zachary D Fischer, PhD, MT-BC
• Phone: (908) 281-1324
• Email: zachary.fischer[@]hmhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 24, 2025
• Est. primary completion date: April 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Spectrum and Other Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Carrier Clinic	Belle Mead	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Hackensack Meridian Health	American Music Therapy Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)