Mental Health IssuesNCT05723328
Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma
A study testing Group Music Therapy Advocacy Recording Intervention (MTAR) in people with Mental Health Issues and Bipolar Disorder, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
This study will use a systematic music therapy intervention on patients with mental illness trying to help them with their internalized stigma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Health Issues, Bipolar Disorder, Depressive
- What is being tested?
- Group Music Therapy Advocacy Recording Intervention (MTAR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2023to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients on S1 status (1:1 patient observation) or isolation protocol
- Evidence of organic brain disease, severe acute symptomatology, hearing deficit, and intellectual disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Group Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma in Adult Psychiatric Inpatients in Acute Care
This study will use a systematic music therapy intervention on patients with mental illness trying to help them with their internalized stigma.
Read the 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.
- Conditions
- Mental Health Issues, Bipolar Disorder, Depressive, Schizophrenia Spectrum and Other Psychotic Disorders, Anxiety Disorder
- Being tested
- Group Music Therapy Advocacy Recording Intervention (MTAR)
- Keywords
- Internalized stigma, Music therapy, Music Therapy Advocacy Recording Intervention, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Health Issues
- Medical subject headings
- Bipolar Disorder, Schizophrenia Spectrum and Other Psychotic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Music Therapy Advocacy Recording Intervention (MTAR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post MTAR intervention (day 8-10)
Secondary outcomes (1)
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.
Measured: Post MTAR intervention (day 8-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start25 Apr 2023
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Why it stopped: Resource Limitations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental Health IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pseudo cluster randomized controlled design (Borm et al., 2005) will take advantage of the unit's two separate residential areas
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Music Therapy Association
- Responsible party
- Sponsor
- Investigators
- Zachary D Fischer, PhD, MT-BC, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723328
- Sponsor's protocol ID
- Pro2022-0570
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2023
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Group Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma in Adult Psychiatric Inpatients in Acute Care
- ClinicalTrials.gov ID
- NCT05723328
- Acronym / sponsor ID
- Pro2022-0570
- Conditions
- Mental Health Issues, Bipolar Disorder, Depressive, Schizophrenia Spectrum and Other Psychotic Disorders, Anxiety Disorder
- Keywords
- Internalized stigma, Music therapy, Music Therapy Advocacy Recording Intervention, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Health Issues
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resource Limitations
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- American Music Therapy Association
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Posted 5 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pseudo cluster randomized controlled design (Borm et al., 2005) will take advantage of the unit's two separate residential areas
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Group Music Therapy Advocacy Recording Intervention (MTAR)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients on S1 status (1:1 patient observation) or isolation protocol
- Evidence of organic brain disease, severe acute symptomatology, hearing deficit, and intellectual disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 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. | Behavioural | Treatment Group |
Primary outcome
Change in the Internalized Stigma of Mental Illness Inventory (ISMI) Score Between Pre and Post MTAR
Time frame: 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.
1 secondary outcome
Change in the ISMI Score Based on Diagnostic Category
Time frame: Post MTAR intervention (day 8-10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary D Fischer, PhD, MT-BC principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Music Therapy Advocacy Recording Intervention (MTAR) in people with Mental Health Issues and Bipolar Disorder, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Internalized Stigma of Mental Illness Inventory (ISMI) Score Between Pre and Post MTAR (time frame: Post MTAR intervention (day 8-10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.