NCT05723328

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 5, 2024

Completed
Last Updated

July 5, 2024

Status Verified

June 1, 2024

Enrollment Period

1 day

First QC Date

February 1, 2023

Results QC Date

December 19, 2023

Last Update Submit

June 26, 2024

Conditions

Keywords

Internalized stigmaMusic therapyMusic Therapy Advocacy Recording InterventionSchizophrenia Spectrum and Other Psychotic DisordersMental Health Issues

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in the ISMI Score Based on Diagnostic Category

    Post MTAR intervention (day 8-10)

Study Arms (2)

Treatment Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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.

Interventions

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.

Treatment Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients on S1 status (1:1 patient observation) or isolation protocol
  • Evidence of organic brain disease, severe acute symptomatology, hearing deficit, and intellectual disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carrier Clinic

Belle Mead, New Jersey, 08502, United States

Location

MeSH Terms

Conditions

Bipolar DisorderSchizophrenia Spectrum and Other Psychotic DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Results Point of Contact

Title
Zachary D. Fischer PhD, MT-BC
Organization
Hackensack Meridian Carrier Clinic

Study Officials

  • Zachary D Fischer, PhD, MT-BC

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Pseudo cluster randomized controlled design (Borm et al., 2005) will take advantage of the unit's two separate residential areas
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

April 25, 2023

Primary Completion

April 26, 2023

Study Completion

April 26, 2023

Last Updated

July 5, 2024

Results First Posted

July 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations