Not provided
Not provided
Not provided
Not provided
Not provided
Resource Limitations
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Music Therapy Association | OTHER |
Not provided
Not provided
Not provided
Not provided
This study will use a systematic music therapy intervention on patients with mental illness trying to help them with their internalized stigma.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Music Therapy Advocacy Recording Intervention (MTAR) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zachary D Fischer, PhD, MT-BC | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrier Clinic | Belle Mead | New Jersey | 08502 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Consented Patients Randomized to Unit W | Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma randomized to ACU West |
| FG001 | Consented Patients Randomized to Unit E |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2022 |
Not provided
Pseudo cluster randomized controlled design (Borm et al., 2005) will take advantage of the unit's two separate residential areas
Not provided
Not provided
Not provided
Not provided
|
| Post MTAR intervention (day 8-10) |
Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma randomized to ACU East
| Received Music Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Consented Patients | Patients consented for the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma by not randomized |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
| |||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study interventions never took place | Posted | Post MTAR intervention (day 8-10) |
|
| |||||||||||||||||||
| 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. | Study procedures never took place | Posted | Post MTAR intervention (day 8-10) |
|
|
Up to 10 days post admission
No study procedures were initiated and no music therapy intervention was introduced to study participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Consented Patients | Patients consented but not received the the Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma | 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zachary D. Fischer PhD, MT-BC | Hackensack Meridian Carrier Clinic | 908-281-1324 | Zachary.Fischer@hmhn.org |
| Dec 19, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
|
| Non-binary |
|
|