Trial Outcomes & Findings for Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma (NCT NCT05723328)

NCT ID: NCT05723328

Last Updated: 2024-07-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Post MTAR intervention (day 8-10)

Results posted on

2024-07-05

Participant Flow

Participant milestones

Participant milestones
Measure
Consented Patients Randomized to Unit W
Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma randomized to ACU West
Consented Patients Randomized to Unit E
Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma randomized to ACU East
Overall Study
STARTED
5
2
Overall Study
Received Music Therapy
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
5
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Consented Patients Randomized to Unit W
Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma randomized to ACU West
Consented Patients Randomized to Unit E
Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma randomized to ACU East
Overall Study
Investigator's Decision
5
2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Consented Patients
n=7 Participants
Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma by not randomized
Age, Customized
40 years
n=7 Participants
Sex/Gender, Customized
Female
4 Participants
n=7 Participants
Sex/Gender, Customized
Male
2 Participants
n=7 Participants
Sex/Gender, Customized
Non-binary
1 Participants
n=7 Participants
Region of Enrollment
United States
7 participants
n=7 Participants

PRIMARY outcome

Timeframe: Post MTAR intervention (day 8-10)

Population: Study interventions never took place

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post MTAR intervention (day 8-10)

Population: Study procedures never took place

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.

Outcome measures

Outcome data not reported

Adverse Events

Consented Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zachary D. Fischer PhD, MT-BC

Hackensack Meridian Carrier Clinic

Phone: 908-281-1324

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place