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Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma

Primary Purpose

Mental Health Issues, Bipolar Disorder, Depressive

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Music Therapy Advocacy Recording Intervention (MTAR)
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Health Issues focused on measuring Internalized stigma, Music therapy, Music Therapy Advocacy Recording Intervention, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Health Issues

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carrier ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 1, 2023
Last Updated
April 25, 2023
Sponsor
Hackensack Meridian Health
Collaborators
American Music Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT05723328
Brief Title
Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma
Official Title
The Effect of a Group Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma in Adult Psychiatric Inpatients in Acute Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
April 24, 2025 (Anticipated)
Study Completion Date
April 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
Collaborators
American Music Therapy Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issues, Bipolar Disorder, Depressive, Schizophrenia Spectrum and Other Psychotic Disorders, Anxiety Disorder
Keywords
Internalized stigma, Music therapy, Music Therapy Advocacy Recording Intervention, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Health Issues

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Music Therapy Advocacy Recording Intervention (MTAR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Internalized Stigma of Mental Illness Inventory (ISMI) score between pre and post MTAR
Description
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.
Time Frame
Post MTAR intervention (day 8-10)
Secondary Outcome Measure Information:
Title
Change in the ISMI score based on diagnostic category
Description
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.
Time Frame
Post MTAR intervention (day 8-10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zachary D Fischer, PhD, MT-BC
Phone
(908) 281-1324
Email
zachary.fischer@hmhn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary D Fischer, PhD, MT-BC
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carrier Clinic
City
Belle Mead
State/Province
New Jersey
ZIP/Postal Code
08502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary D Fischer
Phone
908-281-1324
Email
zachary.fischer@hmhn.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma

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