- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05723328
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Belle Mead, New Jersey, United States, 08502
- Recruiting
- Carrier Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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.
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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.
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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.
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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
Time Frame: Post MTAR intervention (day 8-10)
|
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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the ISMI score based on diagnostic category
Time Frame: Post MTAR intervention (day 8-10)
|
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2022-0570
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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