An interventional study of Group Music Therapy Advocacy Recording Intervention (MTAR) in Mental Health Issues, Bipolar Disorder and Depressive, sponsored by Hackensack Meridian Health. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Hackensack Meridian Health · Not applicable, Interventional, and Supportive care
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.
1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.
This study's enrollment of 7 is below the median of 63 across 1,245 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Hackensack Meridian Health is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
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.
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.
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)
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)
| Milestone | Consented Patients Randomized to Unit W | Consented Patients Randomized to Unit E |
|---|---|---|
| Started | 5 | 2 |
| Received music therapy | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 5 | 2 |
| Withdrew: Investigator's decision | 5 | 2 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Up to 10 days post admission. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Consented Patients | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Customized(years) | Consented Patients |
|---|---|
| Median | 40 (26 to 64) |
| Sex/Gender, Customized(Participants) | Consented Patients |
|---|---|
| Female | 4 |
| Male | 2 |
| Non-binary | 1 |
| Race and Ethnicity Not Collected(Participants) | Consented Patients |
|---|
| Region of Enrollment(participants) | Consented Patients |
|---|---|
| United States | 7 |
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Plan to share: No
Ran from Apr 2023 to primary completion in Apr 2023, 0 months.
Results were first posted in Jul 2024, 1 year 2 months after primary completion.
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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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