Anxiety Disorder, Bipolar Disorder, Depressive, Mental Health Issues, Schizophrenia Spectrum and Other Psychotic Disorders
Conditions
Keywords
Internalized stigma, Music therapy, Music Therapy Advocacy Recording Intervention, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Health Issues
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.
Interventions
BEHAVIORALGroup 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.
Sponsors
American Music Therapy Association
Hackensack Meridian Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Pseudo cluster randomized controlled design (Borm et al., 2005) will take advantage of the unit's two separate residential areas
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Consented Patients Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma by not randomized | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Investigator's Decision | 5 | 2 |
Baseline characteristics
| Characteristic | Consented Patients | — |
|---|---|---|
| Age, Customized | 40 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 7 participants | — |
| Sex/Gender, Customized Female | 4 Participants | — |
| Sex/Gender, Customized Male | 2 Participants | — |
| Sex/Gender, Customized Non-binary | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
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.
Time frame: Post MTAR intervention (day 8-10)
Population: Study interventions never took place
Secondary
Change in the ISMI Score Based on Diagnostic Category
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.
Time frame: Post MTAR intervention (day 8-10)
Population: Study procedures never took place