Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma

Sponsor

Hackensack Meridian Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05723328

Collaborator

American Music Therapy Association (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Issues Bipolar Disorder Depressive Schizophrenia Spectrum and Other Psychotic Disorders Anxiety Disorder	Behavioral: Group Music Therapy Advocacy Recording Intervention (MTAR)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pseudo cluster randomized controlled design (Borm et al., 2005) will take advantage of the unit's two separate residential areasPseudo cluster randomized controlled design (Borm et al., 2005) will take advantage of the unit's two separate residential areas

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Mar 14, 2025

Anticipated Study Completion Date :

Mar 14, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in the Internalized Stigma of Mental Illness Inventory (ISMI) score between pre and post MTAR [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.

Secondary Outcome Measures

Change in the ISMI score based on diagnostic category [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.