Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma

NCT ID: NCT05723328

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2023-04-26

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.

Conditions

Mental Health Issues; Bipolar Disorder; Depressive; Schizophrenia Spectrum and Other Psychotic Disorders; Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Group Music Therapy Advocacy Recording Intervention (MTAR)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Music Therapy Association

OTHER

Sponsor Role: collaborator

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zachary D Fischer, PhD, MT-BC

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Carrier Clinic

Belle Mead, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro2022-0570

Identifier Type: -

Identifier Source: org_study_id