The Effect of a Group Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma in Adult Psychiatric Inpatients in Acute Care
Phase: NA
Conditions: Mental Health Issues, Bipolar Disorder, Depressive, Schizophrenia Spectrum and Other Psychotic Disorders, Anxiety Disorder
Sponsor: Hackensack Meridian Health

 
CLINICAL STUDY PROTOCOL  
 
The Effect of a Group Music Therapy Advocacy Recording Intervention 
(MTAR) on Internalized Stigma in Adult Psychiatric Inpatients in Acute 
Care 
 
10/20/2022  
version 1.03 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

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Study Personnel  
PI:  
Zachary D. Fischer, PhD, MT-BC  
Creative Art Therapist  
Clinical Social Services 
Hackensack Meridian Health Carrier Clinic 
252 County Road 601, Belle Mead, NJ 08502 
Office: (908) 281-1324     
Cell: (410) 916-5438  
Statistical support:  
Simon Gelman, PhD  
Research Biostatistician  
Office of Clinical Research Administration 
Hackensack Meridian Health 
Protocol Development support: 
Elli Gourna Paleoudis, MS, PhD 
Manager, Investigator Initiated Research Program 
HMH REDCap Administrator 
Office of Research Administration 
Hackensack Meridian Health 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations  

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Abbreviation  
 
ACU 
APA 
DSM-5 
 
 
HMHCC 
ISMI 
MT 
MTAR 
Explanation 
 
Acute Care Unit 
American Psychiatric Association 
Diagnostic and Statistical Manual of Mental 
Disorders (5th ed.; American Psychiatric 
Association, 2013) 
Hackensack Meridian Health Carrier Clinic 
Internalized Stigma of Mental Illness Inventory 
Music Therapist or Music Therapy 
Music Therapy Advocacy Recording 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Summary   
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.  

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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 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 – Introduction  
This study will be investigating the effects of the Music Therapy Advocacy Recording 
intervention (MTAR) on internalized stigma in adult inpatients in acute psychiatric care. 
MTAR is a sequence of group music therapy songwriting and recording sessions framed as 
a mental health awareness project to be shared with the general public. Internalized stigma 
is the subjective, nonconscious process of assimilating socially transmitted stereotypes and 
negative messages about mental illness into one’s own belief system (Corrigan, 2005; Link, 
2001; VandenBos, 2007). It is distinct from direct experiences and perceptions of social 
stigma (Corrigan, 2005; Hinshaw, 2009). Internalized stigma is negatively associated with 
quality of life (Degnan et al., 2021; Picco et al., 2016), self-esteem (Lysaker et al., 2008; 
Segalovich et al., 2013), recovery orientation (Yanos et al., 2008), morale (Ritsher & Phelan, 
2004), social adaptation (Firat, 2020; Link, 1987; Lysaker et al., 2007; Perlick et al., 2001), 
general functioning (Yanos et al., 2012; Muñoz et al., 2011), symptom severity (Corrigan, 
2004; Livingston & Boyd, 2010; Lysaker, 2010; Tesfaye, 2020), treatment adherence (Fung 
et al., 2009), and medication adherence (Semahegn et al., 2021), and it is positively 
associated with delayed treatment seeking (Fox et al., 2018; Sirey et al., 2001; Tucker et al., 
2013; Vogel et al., 2013; Wade et al., 2015) and greater risk of suicide (Schomerus et al., 
2015). Considering the scope and gravity of related outcomes, developing treatment 
strategies for internalized stigma has naturally become a topic of considerable interest in 
current mental health research. 
 
Five recently published meta-analyses and systematic reviews (Alonso et al., 2019; Büchter 
& Messer, 2017; Tsang et al., 2016; Wood et al, 2016; Yanos et al., 2015) have drawn mixed 
conclusions about the efficacy of interventions designed to address internalized stigma.  
Tsang et al. (2016) assert that “most internalized stigma reduction programs appear to be 
effective”, while Büchter & Messer (2017), “did not find any encouraging results”. Authors’ 
conclusions and recommendations for optimal intervention development and approach are 
similarly varied. Alonso et al. (2019) posit that psychoeducation and interventions combining 
elements of psychoeducational, cognitive-behavioral, narrative, motivational, peer support, 
and empowerment strategies showed the best results.  Wood et al. (2016) recommend that 
interventions target specific demographics, while Tsang et al. (2016) call for more innovation.  
For Büchter & Messer (2017), the most important aspects of developing new approaches are 
systematic literature review and involvement with people from stigmatized groups. The wide 
array of recommendations from these authors highlights the need for more research in this 
area, including the need for new evidence-based interventions to address internalized 
stigma.  
 
None of these systematic reviews and meta-analyses evaluate music therapy approaches. 
Music therapy is currently used in a wide range of mental health settings with diverse and 
varied populations (Eyre, 2013). Recent Cochrane reviews of music therapy and depression 
(Aalbers et al., 2017) and schizophrenia (Geretsegger et al., 2017) found that music therapy 
can improve functioning and quality of life, and reduce depressive and anxiety symptoms in 
patients with depression and schizophrenia. Sparse but promising research has suggested 
the potential efficacy of music therapy for addressing internalized stigma (Silverman, 2013; 
Woofenden, 2020) with songwriting, improvisation, and community performance-based 
methods.  The intervention designed for this study combines elements of these methods in a 
way that is informed by the music therapy literature, and expands upon these approaches 
with the added component of a music therapy recording session aimed at creating music for 
mental health awareness. 

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Though a rich precedent exists for utilizing recording technology in music therapy, its clinical 
potential and therapeutic relevance have not been systematically investigated.  Kirkland & 
Nesbitt (2019) offer a model of therapy-oriented recording as a medium for self-reflection and 
personal narrative review for patients with concurrent psychiatric disorders.  When framed as 
a mental health advocacy project to be released to the general public, recording the patient-
composed song in the MTAR treatment sequence offers patients an opportunity to 
proactively work together in a socially supportive context to change public perception of 
mental illness, to refute self-relevance of stereotypes by strengthening and broadening self-
concept, and empower themselves and each other with creative, expressive tools to confront 
and adapt to the “experience, perception, or anticipation of negative social reactions” 
(Livingston & Boyd, 2010) to mental illness that initiate stigma internalization. 
 
In this study, subjects will work together with a certified music therapist (MT) in groups of 5 to 
7 subjects per group to compose, rehearse, and record a song to be released to the general 
public for the purpose of generating anti-stigma mental health awareness. The primary 
objective is to reduce internalized stigma from baseline relative to the control group as 
measured by the 29-item Internalized Stigma of Mental Illness Inventory (ISMI; Ritsher et al., 
2003).  The secondary objective, examining the association between treatment effect and 
diagnostic category, can assist in generating hypotheses related to effective implementation. 
The exploratory goal of the study is to examine the potential for the treatment effect of the 
music therapy intervention to persist after 21 days from baseline. 
 
The mechanism of change in this study is rooted in the aesthetic decision-making intrinsic to 
the musical experiences of songwriting, active music-making, and music recording. In 
making these decisions, subjects integrate symbolic representations of the lived experience 
of stigma into a healthy and expanded self-concept. This process is aided by the mutual 
social support in collaborating on the artistic product, transforming the negative experiences 
and perceptions of social stigma into an object of beauty and a catalyst for social change. 
The recording also serves as a post-treatment reminder of the subject’s successful 
attainment of a meaningful goal and their agency to effect positive change. 
2 – Background  
2.1. Background/literature review 
There is substantial literature examining the processes related to stigma internalization and 
approaches to address it. The impact of internalized stigma upon a person’s recovery is 
connected to how they make sense of their subjective experience and diagnosis of mental 
illness in the context of widely-held beliefs (Yanos et al., 2010). The “Illness Identity” model 
(Lysaker et al., 2007; Yanos et al., 2008, 2010, & 2020) describes how internalized stigma 
precipitates poor outcomes via the “insight paradox” (Lysaker et al., 2007) which posits that 
the interaction between stigma internalization and increased awareness of one’s mental 
illness results in increased hopelessness and decreased self-esteem. Hopelessness and low 
self-esteem contribute to increased avoidant coping, leading to increased risk of suicide, 
social interaction, and vocational functioning, which can amplify symptom severity (Lysaker 
et al., 2007; Yanos et al., 2008, 2010, 2020).   
 
Recent meta-analyses offer insight into theoretical foundations of programs seeking to 
address internalized stigma. Degnan et al (2021)  conclude that “psychological interventions 
should target improvements in [self-concept and social networking] to reduce the negative 
impact of stigma on quality of life in psychosis”. Yanos et al. (2015) assert that “tools and 
experiences designed to increase or elicit hope, empowerment, and motivation to act toward 
one’s goals and according to one’s values” are important components of interventions aimed 
at reducing internalized stigma. In alignment with these recommendations, this music 
therapy approach offers subjects opportunities to expand self-concept by highlighting their 
innate aesthetic sensibilities as expressed in the creative process, provides tools to engage 
in self-advocacy which can transform “illness identity” into an empowered self-concept, and 
utilizes the intrinsic motivation of musical experiences to instill hope in the accomplishment of 

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a specific goal. The collaborative group format provides opportunities for participants to build 
social skills that can be used to strengthen post-treatment support networks.  
 
Drapalski et al. (2013) identify four clinical “pathways” intended for use as a basis for 
developing interventions targeted at reducing internalized stigma. The MTAR intervention 
utilizes each of the four in a distinct phase: Songwriting and Arrangement, Rehearsal, 
Recording, and Review (see Table 1). 
 
Clinical “pathway”, Drapalski et al. 
(2013) 
Related MTAR 
phase(s) 
Description of MTAR phase 
Undermine the perceived accuracy 
and self-relevance of stereotypes 
Verbal Processing; 
Songwriting and 
Arrangement 
Confront and refute stereotypes 
by sharing personal perspectives 
and experiences of stigma in lyric 
writing.  
Reinforce the inaccuracy of 
stereotypes by broadening self-
concept 
Rehearsal 
Build a sense of competence and 
mastery rooted in intrinsic 
musicality, aesthetic sensibility, 
and creative expression.  
Realistically assess rejection 
probability 
Recording 
Experience acceptance, social 
support, and group cohesion in 
the face of potential judgment and 
rejection; access vulnerability by 
making musical decisions based 
on personal aesthetic. 
Connect with non-stigmatizing 
others 
Editing and Review 
Work together to achieve a sense 
of pride and connectedness in 
accomplishing a goal; connect 
with others in the pursuit of 
betterment on intrapersonal, 
interpersonal, and societal levels.  
Table 1. Phases of MTAR treatment sequence as related to Drapalski et al.’s (2013) model 
 
Narrative enhancement approaches are also common in interventions that address 
internalized stigma (Alonso, 2019; Roe et al., 2010; Yanos et al., 2012). These approaches 
utilize cognitive restructuring techniques (Beck, 1970) to challenge maladaptive beliefs by 
developing self-affirming personal narratives.  This study does not utilize narrative 
enhancement or cognitive restructuring per se, but draws from and expands on these 
techniques conceptually. By centering an advocacy project on a shared group narrative in 
the context of aesthetic expression, the intervention offers participants opportunities to 
reframe their life histories from a self-affirming perspective, and to substantiate the reframing 
with a new experience that can build self-efficacy and a sense of mastery (Schulze, 2009), 
and nurture a sense of connectedness to a larger whole.    
 
Yanos et al. (Yanos et al., 2010) suggest group advocacy work as a potential treatment for 
internalized stigma, and highlight the efforts of mental health consumer advocacy and self-
help groups to aid mental illness recovery by empowering identity transformation. Qualitative 
evidence suggests that the “mental health consumer” approach can help patients integrate 
negative experiences into a healthy self-concept through self-disclosure combined with 
advocacy work (McCoy et al., 1994; Onken & Slaten, 2000). The potential for these 
programs to increase resistance to stigma internalization, while promising, has not been 
systematically studied. The proposed study draws from the self-disclosure and self-advocacy 
elements of the mental health consumer movement, but it is not peer-led or a self-help 
group. The music therapist-led format was selected because the typically higher acuity of 

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hospitalized subjects necessitates a consistent and coherent procedure with skilled 
facilitation to contain and ground the work. 
 
Of recently developed interventions included in meta-analyses and systematic reviews that 
demonstrated a significant reduction of internalized stigma, the intervention most similar to 
the current study is Photovoice (Russinova et al., 2014). Photovoice is a peer-based 
photography intervention combined with psychoeducation, personal narrative construction, 
and community activism. Like MTAR, Photovoice aligns with Drapalski et al.’s (2013) and 
Degnan et al.’s (2021) recommendations for intervention development, and incorporates the 
identity transformation work of the mental health consumer movement (Yanos et al., 2010) by 
working in groups to create an artistic product aimed at effecting social change. The core 
principle of both MTAR and Photovoice is to integrate negative memories of stigmatizing 
experiences into an empowered narrative, which is then realized as an aesthetic artifact and 
transmitted to a wide audience as an agent of social change. However, MTAR differs from 
Russinova et al.’s (2014) study in a number of significant ways (see Table 2). 
 
Though MTAR is grounded in the research literature related to internalized stigma treatment, 
there are two notable divergences. First, nearly all published studies included in meta-
analyses examine interventions that take place as part of outpatient treatment. While 
outpatient approaches may be less complicated to implement and measure, they are often 
remedial of internalizing stigmatizing experiences related to inpatient hospitalization. MTAR 
is implemented during inpatient treatment, at the critical juncture when the internalization of 
experiences related to hospitalization is nascent.  Second, most interventions include 
psychoeducation as a fundamental component. Psychiatric inpatients, who typically present 
with a higher acuity level and may be psychotic or actively decompensating, can lack the 
insight for significant reflexive thinking, and can rarely self-regulate to the degree required to 
sit for a 60- or 90-minute psychoeducation class. For this reason, psychoeducation in this 
study is limited to a 10-minute introduction to the concept of internalized stigma in the first 
session of the treatment sequence. 
 
A major benefit of addressing internalized stigma in an inpatient setting with music therapy is 
that musical experiences are intrinsically motivating and pleasurable. This stands in contrast 
with much of the inpatient psychiatric hospital experience, which is often characterized by 
isolation (Lindgren et al., 2019), feeling unsafe (Berg et al., 2017), powerlessness related to 
a perceived lack of influence on choice of medication and treatment (Færden et al., 2020), 
and feeling bored or “caged in” (Stewart et al., 2015).  Music therapy is a non-threatening 
opportunity to take part in new experiences with new people. Combined with the acquired 
awareness of internalized stigma in the presence of social support, engaging in new 
experiences can strengthen participants’ resistance to stigmatization by building internal 
resources based on the need for novel experiences (Szcześniak et al., 2018). 
In a peer-reviewed music therapy study that provides quantitative data that demonstrates a 
reduction in internalized stigma in an inpatient psychiatric setting, Silverman (2013) 
examines the effects of a songwriting intervention in which subjects compose lyrics for “The 
Stigma Blues”.The study concluded that music therapy was significantly more effective in 
addressing internalized stigma relative to the control group, and the author suggests that the 
songwriting  
 
Photovoice (Russinova et 
al., 2014) Characteristic 
MTAR Characteristic 
Rationale of Divergence 
Narrow diversity of 
demographic characteristics 
in study sample/small 
sample size 
Broad diversity of 
demographic characteristics 
at HMHCC; larger sample 
size 
Greater generalizability of 
research findings 

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One-dimensional mode of 
creative expression 
(photography) 
Multiple modes of creative 
expression: lyric-writing, 
composing, performing, and 
recording music.   
 
Engaging in creative 
expression in various 
aesthetic modes offers 
opportunities to adapt to 
changing and evolving 
moods, perspectives, and 
feelings in real-time. 
Parallel creative process 
Collaborative creative 
process 
Collaborating on a single 
work of art, rather than 
multiple individual works, 
requires a greater 
investment in social 
interaction. 
Collection of individual 
narratives 
Individual narratives 
integrated into a group 
narrative 
Building a group narrative 
creates more opportunities 
for group cohesion 
Peer-led 
Music therapist as facilitator  
MT can guide, contain, 
ground the sessions for 
higher-acuity inpatients; 
create meaningful 
opportunities by interfacing 
between patient and 
technology; occupy a 
supportive role in realizing 
group aesthetic 
Outpatient 
Inpatient 
Prompt intervention to 
improve outcomes 
Table 2. Comparison of Photovoice (Russinova et al., 2014) and MTAR Characteristics and 
Rationale of Divergence 
process contributed to a disinhibition of self-disclosing personal histories of stigmatizing 
experiences (Silverman, 2013).  MTAR includes a songwriting component, but also expands 
upon Silverman’s approach (See Table 3). 
 
The use of recording technology to address internalized stigma is a novel approach. A 
qualitative music therapy study based on a community music therapy approach (Solli & 
Rolvsjord, 2015) which included recording, mixing, and producing music, subjects 
emphasized that music therapy “represented freedom from illness, stigma, and treatment”. 
This suggests that a music therapy recording session can provide a locus for transforming a 
participant’s illness identity. Using recording technology creates the opportunity to utilize the 
public relations and social media infrastructure of the hospital to to promulgate the work as 
part of a mental health awareness project. Participants’ belief in their potential to effect large-
scale societal change via musical expression of their personal experiences is the central 
mechanism for instilling feelings of empowerment and motivation in this study.  
 
“The Stigma Blues” 
(Silverman, 2013) 
Characteristic  
MTAR Characteristic 
Rationale of Divergence 
Single-session intervention 
Four-phase treatment 
sequence over five 
sessions 
Build trust, group cohesion, 
engagement with the musical 
process  
Blues format 
Open musical format 
Broad scope of musical 

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expression 
No advocacy component 
Advocacy-based 
Identity transformation through 
empowerment 
MT performs the music 
Subjects rehearse and 
perform the music 
Identity transformation through 
competence and mastery 
No recording component 
Includes Recording and 
Review Phases 
Extend treatment effect by 
monumentalizing the work for 
reflection and insight 
Demographic data 
(diagnosis) not collected 
Demographic data 
(diagnosis) collected 
Investigate potential 
relationships between 
treatment effect and diagnoses 
to inform future developments 
and implementation 
Table 3. Comparison of “The Stigma Blues” (Silverman, 2013) and MTAR Characteristics 
and Clinical Rationale of Divergence 
 
Using recording technology creates a record of subjects’ achievement that can be accessed 
at any time in the future and serve as a post-inpatient treatment reinforcement of an 
empowered identity, potentially extending the treatment effect. MTAR’s actual capacity to 
induce systemic change is out of scope for this study.  
 
The proposed study fills the gap between Photovoice (Russinova et al., 2014), the mental 
health consumer movement (McCoy et al., 1994; Onken & Slaten, 2000), and the music 
therapy research of Silverman (2013) and Solli & Rolvsjord (2015) with an inpatient 
treatment sequence that combines elements of artistic collaboration to bolster self-esteem, 
self-concept, and social support; and community activism building a sense of agency, self-
efficacy, and empowerment. It will focus on how the music therapy group, in nurturing 
expressive and aesthetic modes-of-being centered on mental health advocacy in the context 
of peer support, can diminish or prevent internalized stigma. 
3 – Rationale, Objectives and Hypothesis   
3.1. Study Rationale/Problem Statement/Research question or Study significance  
What are the effects of a music therapy intervention focused on writing, recording, and 
releasing music to the general public for the purpose of mental health advocacy on 
internalized stigma of mental illness among adult inpatients in acute care?  
3.2. Hypothesis 
Adult psychiatric inpatients on an acute care unit who participate in music therapy groups 
focused on writing, recording, and releasing music to the general public for the purpose of 
mental health advocacy will report less internalized stigma from baseline relative to the 
control group upon completion of the treatment sequence, regardless of subject diagnosis.  
The effect will persist when measured at 3-weeks post-baseline.  
 
3.3. Primary Objective  
Reduce internalized stigma of mental illness among adult inpatients in acute care with a 
music therapy intervention focused on writing, recording, and releasing music to the 
general public for the purpose of mental health advocacy.  
3.4. Primary Outcome Variables  
ISMI score pre-treatment, ISMI score post-treatment  
3.5. Secondary Objective 
Reduce internalized stigma of mental illness across subject diagnostic categories. ISMI 

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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 ed.; DSM–5; 
American Psychiatric Association, 2013). 
3.6. Secondary Outcome Variable 
ISMI score pre-treatment, ISMI score post-treatment, ISMI score 3 weeks post-treatment, 
Diagnostic Category: No Diagnosis, Diagnostic Category: Schizophrenia Spectrum and 
Other Psychotic Disorders, Diagnostic Category: Bipolar and Related Disorders, 
Diagnostic Category: Depressive Disorders, and Diagnostic Category: Anxiety Disorders  
3.7. Exploratory Objective  
Examine the persistence of the treatment effect, to be measured at 3 weeks after 
completion of the treatment sequence. 
3.8. Exploratory Outcome Variables 
ISMI score 3 weeks post-treatment  
 
4 - Study Design  
4.1 General Design  
This prospective clinical trial’s pseudo cluster randomized controlled design (Borm et al., 
2005) will take advantage of the unit’s two separate residential areas (“wings”, ACU West 
and ACU East) to minimize contamination and selection bias by randomizing treatment and 
control conditions to each wing, rather than each individual subject (see Figure 1).  
 
Figure 1. Pseudo Cluster Randomization Procedure 
Patients on the unit currently receive opportunities to take part in several groups per day 
focused on topics of coping skills, mindfulness, journaling, creative arts, wellness recovery, 
recreation, and at least one music therapy group, as part of the standard of care. The current 
study improves upon the standard of care by providing a protocolized intervention sequence 
targeted at reducing internalized stigma of mental illness. 
The intervention consists of a sequence of five music therapy songwriting 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 (Ritsher et al., 2003; Appendix 2). 
4.1.1 Study Duration  
The proposed study duration is one year, with eight months allotted for data collection, and 
four months allotted for data analysis. Subjects will be involved for a period of 21 days, 
including follow-up data collection (See Table 4). Results of this study can help inform the 
feasibility of collecting follow-up data from this population, as patient adherence to aftercare 
plans can be unpredictable. 
 
Day 
Treatment Group 
Control Group 
ACU West 
 
 ACU East 
Random assignment 
 
Treatment group 
Control group 

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1-3 
Enrollment, Pre-
Test/Baseline 
Enrollment, Pre-Test 
4-10 
Treatment Sequence 
No Treatment Sequence 
8-10 
Post-Test 
Post-Test 
21 
Follow-up data collected 
Follow-up data collected 
Table 4. Study Timeline Per Cohort 
4.1.2 Number of Study Sites  
This study will take place at Hackensack Meridian Health Carrier Clinic, 252 County Road 
601, Belle Mead, NJ 08502 
4.2 Study Population  
All patients who are anticipated to remain admitted to the unit for at least 7 days will be 
considered regardless of gender or racial/ethnic background with the exception of those less 
than 18 years of age.  Additional exclusion criteria will include S1 status (1:1 patient 
observation), evidence of organic brain disease, severe acute symptomatology, hearing 
deficit, and intellectual disability.  Eligible patients must be able to read and comprehend the 
ISMI questionnaire, and provide informed consent as determined by their doctors. 
4.2.1. Number of Participants  
Based on power analysis (power=80%, see other assumptions in section 5.8.1) and the 
design of the study, 50 patients will be accrued to each group (n=100). 
4.2.2. Eligibility Criteria  
 Eligible patients include adults age 18-65 who have been admitted to the HMHCC ACU, and 
must be able to read and comprehend the ISMI questionnaire, provide informed consent, 
and have severe mental illness of prolonged duration with a significant degree of disability or 
social dysfunction (Ruggeri et al., 2000). 
 
Exclusion criteria will include patients younger than 18 or older than 65, patients on S1 status 
(1:1 patient observation) or isolation protocol, evidence of organic brain disease, severe 
acute symptomatology, hearing deficit, and intellectual disability. 
4.2.3. Vulnerable populations 
Patients on medical isolation protocol (such as those who test positive for COVID-19 while 
hospitalized) and patients that are unable to provide their own consent will be excluded from 
the study. 
4.2.4. Withdrawal criteria  
Subjects may withdraw from the study at any time by stating their wish to withdraw to 
research staff. No new data will be collected from withdrawn subjects. However, all data that 
have already been collected for study purposes will remain. 
4.3. Study procedures  
Patients will be identified and referred upon admission to the Acute Care Unit at HMH Carrier 
Clinic by the treatment team (attending doctors, nurses, and social workers).  All subjects 
who are anticipated to remain admitted to the unit for at least 7 days will be considered 
regardless of gender or racial/ethnic background with the exception of those less than 18 
years of age.   
 
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 (Ritsher et al., 2003; Appendix 2).  The ISMI is a widely-used 
measure with acceptable internal consistency (α = .72-.90) and test–retest reliability (r = .68-
.92; Boyd et al., 2014; Chang et al., 2016).  It was selected over the Perceived Devaluation 

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and Discrimination Scale (PDD; Link, 2987) and Self-Stigma in Mental Illness Scale (SSMOI; 
Tucker et al., 2013) due to concerns about internal consistency and psychometric properties 
of these measures (Brohan et al., 2010).  Data collection will include the subject’s name, 
diagnoses, treatment ID number, and ISMI score.  Treatment effect will be measured by 
using a two-factor, mixed-design analysis of variance (ANOVA). A P value of less than 0.05 
will be considered to indicate statistical significance.  
 
Description of Procedures 
The music therapy treatment group will utilize a certified music therapist to facilitate a series 
of 5 group music therapy sessions over the course of 5 to 7 consecutive weekdays. Groups 
will be composed of 5 to 7 patients and the MT. There is no standard number of sessions for 
interventions addressing internalized stigma, and the available literature varies from one 
session in a single day to twenty sessions over a period of months. Since the average length 
of stay for acute care unit patients is 7 to 10 days, 5 sessions is the maximum feasible 
number of sessions to complete the treatment sequence for shorter stays.  Though patients 
typically receive daily music therapy groups as part of the standard of care, this study 
improves upon the standard of care by providing a protocolized intervention sequence 
targeted at reducing internalized stigma of mental illness. 
After enrollment and consent, research staff will administer the ISMI in hard copy to establish 
a pretest baseline. After the treatment sequence of 5 group music therapy sessions, 
research staff will administer the ISMI in hard copy for post-test data. The ISMI will be 
administered by phone or in person by research staff for 3-week follow-up data. 
4.3.1. Study discontinuation 
Subjects may stop taking part in this research study at any time without any penalty.  
If a participant withdraws from the study, no new data about them will be collected for study 
purposes. All data that have already been collected for study purposes will remain. This will 
not affect their ability to receive care at any HMH hospitals or to receive any benefits to 
which they are otherwise entitled.  
4.4. Risks and Benefits   
There are no perceived medical risks to subjects in this music therapy study. Potential 
benefits related to music therapy in this population include improving functioning and quality 
of life, and reducing depressive and anxiety symptoms. The primary potential benefit for this 
study is reduced internalized stigma of mental illness, with secondary potential benefits of 
improving symptoms associated with internalized stigma described above 
The potential for loss of private information always exists; there will be procedures in place 
to minimize this risk (see below). 
 
5 – Methods 
5.1. Screening  
Patients will be screened for eligibility each morning during the treatment team meeting.  See 
section 6.5 (“Informed Consent”) for more information. 
5.2. Recruitment, enrollment and retention (including screen failures as applicable) 
The consent process will take place in a private room in the acute care unit and will be 
overseen by Zachary D. Fischer, PhD, MT-BC, the principal investigator. The process will 
take 15 to 20 minutes, during which time research staff will orient the participant to the study 
and go over the study protocols in detail as indicated in the consent form, making sure that 
participant understands its content. Potential participants will be provided with the 
opportunity to ask any questions or take the consent form to their room and make a decision 
later. The participant will sign the informed consent upon complete understanding of its 
content and agreement on participation in the study.  

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Subjects who are discharged or noncompliant during the treatment phase will be dropped 
from the study, and no further data will be collected from these subjects. Data that has been 
collected will remain. 
 5.3. Study intervention 
A board-certified music therapist will facilitate the five sessions constituting the treatment  
sequence as follows: 
1) verbal processing of a) subjects’ individual experiences and perceptions of stigma, 
and how those experiences have impacted their relationships, available resources, 
mental health, and treatment; and b) the specific misconceptions and inaccuracies 
that contributed to those experiences; culminating in a collaboratively composed song 
title;  
2) reflection upon themes, metaphors, images, and symbols drawn from the discussion 
will inform collaborative lyric-writing. Additionally, the group will begin to make 
musical decisions based on discussion of preferred and relevant musical styles and 
genres, including the selection of one or more reference tracks. A reference track is 
an existing song that can be used as a stylistic or structural model. 
3) group composition and arrangement; 
4) rehearsing and recording the song; and 
5) editing (mixing and mastering) and review.  
The standard of care for ACU patients at HMH Carrier Clinic includes psychoeducational 
and verbal processing groups, and music therapy groups. MTAR exceeds the standard of 
care by offering a targeted treatment sequence that includes music therapy recording 
and self-advocacy. 
5.4. Assignment / randomization 
This prospective clinical trial’s pseudo cluster randomized controlled design will take 
advantage of the unit’s two separate residential areas (“wings”) to control for contamination 
bias by randomizing treatment and control conditions to each wing, rather than each 
individual subject (see Figure 1 above). 
5.5. Section of instruments (to include for all studies with a social behavioral  
intervention)  
Internalized stigma will be assessed after enrollment, within 3 days of admission to the 
hospital (pretest/baseline), at ten days (posttest), and at 3 weeks after baseline (follow-up), 
using the Internalized Stigma of Mental Illness Inventory (Ritsher et al., 2003; Appendix 2).  
The ISMI is a widely-used measure with acceptable internal consistency (α = .72-.90) and 
test–retest reliability (r = .68-.92; Boyd et al., 2014; Chang et al., 2016).  It was selected over 
the Perceived Devaluation and Discrimination Scale (PDD; Link, 2987) and Self-Stigma in 
Mental Illness Scale (SSMOI; Tucker et al., 2013) due to concerns about internal consistency 
and psychometric properties of these measures (Brohan et al., 2010).   
5.6. Data collection (data points, source and storage)  
 Data points will include the subject's name, diagnoses, and treatment ID number, to be 
collected from the medical chart by research staff; and ISMI score, collected from the subject 
by questionnaire administered by the PI.  Data will be collected by research staff and entered 
into REDCap, a secure web application. 
The participant’s file as it relates to this study will only be altered by the PI, who is also the 
clinician implementing the intervention. After each session (and only at this time), the PI will 
briefly document the group topic and the patient’s affect and presentation as observed. For 
example: “(Participant first name) participated in a music therapy songwriting group focused 
on themes of stigma and resilience. (Participant first name) initially presented with a blunted, 
flat affect, becoming more activated and brightening by the end of the session. (He/she/they) 
participated by verbally suggesting the genre ‘(genre)’ and song title ‘(song title)’ for the 
project.” Documentation related to the study will not be differentiated in the participant’s file 
from other therapeutic group activity.  
 
5.7. Follow-up and end-of study 

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Subjects will be hospitalized for at least the first two phases of data collection (pretest and 
posttest). The 3 week follow-up data may be collected either post-discharge or in the 
hospital, as required by the subject’s unique treatment needs.  
Subjects will be hospitalized for at least the first two phases of data collection (pretest and 
posttest), which will be administered in hard copy by research staff. The 3 week follow-up 
data may be collected by research staff either post-discharge by phone or in person in the 
hospital by hard copy, as required by the subject’s unique treatment needs.  
5.8. Statistical Method  
5.8.1. Sample size calculation and justification  
Based on power analysis (power=80%, see assumptions below) and the design of the study, 
50 patients will be accrued to each group (n=100). 
 
The study has a two-factor repeated-measures ANOVA design. For the power analysis, the 
assumption of sphericity will be made (epsilon = 1). Sphericity is the condition where the 
variances of the differences between all combinations of related groups (levels) are equal.  
Assumptions and parameters of power analysis:  
Sphericity: epsilon = 1  
Type I error: alpha = 0.05  
Type Il error: beta = 0.2  
Required power: power = 100(1 – B) = 80%  
Effect size: f = 0.1, 0.25, 0.33, 0.4, 0.8  
Cohen's effect size for F test, 0.1 ("small"), 0.25 ("medium"), 0.33, and 0.4 ("large"). Effect    
size of 0.33 was used. 
5.8.2. Statistical Analysis Plan  
Primary Analysis  
Treatment effect on the primary dependent variable (ISMI score) will be measured by using a 
two-factor repeated-measures analysis of variance (ANOVA). A P value of less than 0.05 will 
be considered to indicate statistical significance.  
Secondary Analysis 
Treatment effect on the secondary dependent variables (diagnosis category) will be 
measured by using a two-factor repeated-measures analysis of variance (ANOVA). A P 
value of less than 0.05 will be considered to indicate statistical significance.  
Exploratory Analysis  
Treatment effect on the exploratory variable (ISMI score 3 weeks after baseline) will be 
measured by using a two-factor repeated-measures analysis of variance (ANOVA). A P 
value of less than 0.05 will be considered to indicate statistical significance.  
6 - Trial Administration  
6.1. Ethical Considerations - Institutional Review Board (IRB) Review  
The study will be conducted according to the International Conference on  Harmonization 
(ICH), Good Clinical Practice (GCP), the Declaration of Helsinki, Institutional  Review Boards 
(IRB) and in accordance with the U.S. Code of Federal Regulations on  Protection of Human 
Rights (21 CFR 50).  
6.2. Institutional Review Board (IRB) Review (list the IRB of record)  
The final study (ICF, HIPAA form as applicable) and data collection tools will be approved by 
the Institutional Review Board (IRB) at HMH. Approval will be received in writing before 
study initiation. Any changes to the study design will be formally documented in 
amendments and be approved by the IRB prior to implementation.  
6.3. Data management (collection, storage etc.)  

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Hard copy data (such as paper questionnaires) will be collected and stored by research staff 
in a locked cabinet. Digital information will be stored on HMH password-protected 
computers. 
6.4. Confidentiality  
Patient charts, collected data, and analyses of the data will adhere to HIPAA & institutional 
patient confidentiality requirements. A unique identifier (study ID number) will be assigned to 
each patient. The study ID number will be included in the data collection tools and analysis 
software while the list with direct identifiers and ID numbers will be stored separately in a 
HMH password-protected computer and/or locked office.  
If results of the study are published, individual names or other identifying information will not 
be used.  
 
The completed audio recording will not contain any PHI aside from the subject’s voice, which 
may be represented if the subject chooses to sing on the recording. Recording will include 
the voices of many people and individual people will not be identified in the recordings.  
Recordings will be posted on social media pending approval from HMH Corporate 
Communications, as per HMH PolicyStat ID 8270519: “The use or creation of a profile on 
any external social media sites for school or work-related purposes, such as blogs, groups 
forums, photo streaming sites, video, and audio must be reviewed and approved by the 
Hackensack Meridian Corporate Communications Department” (Retrieved from 
http://hmh.policystat.com/policy/8270519/).  
6.5. Informed consent  
Informed consent will be obtained prior to any research related activities. Informed consent 
will be documented in the study’s data collection tools and hard copies of the consent form 
will be kept in the PI’s locked office in a locked cabinet.  
 
The majority of the psychiatric inpatient population has legal capacity to provide informed 
consent as well as the ability to make independent treatment decisions. There is a very small 
number of patients who do not have the ability to provide informed consent due to being 
deemed incapacitated by the psychiatrist or nurse practioner. These patients will be 
excluded from participation in this study. 
 
Patients in the hospital routinely sign consent forms for various reasons: release of protected 
information to family members and caregivers; special privileges or greater responsibility on 
the milieu; and certain services (e.g. electroconvulsive therapy). Capacity to sign these forms 
is determined by the patient’s doctor on a case by case basis.  
Consent and appropriateness to participate in this study will be discussed and agreed upon 
by the treatment team, including nurses, social workers, group counselors, doctors, and the 
MT, during the morning report. The treatment team’s collective insight and knowledge of a 
person’s medication, treatment, and illness based on medical records and first hand 
observations of one’s behavior during intake and assessment will determine capacity to 
consent to participate in this study.  
6.6. Data Quality Assurance  
Data will be collected by the PI, who has completed training from the Collaborative 
Institutional Training Initiative (CITI). 
6.7. Study Records (retention etc.)  
Records will be retained in accordance with regulatory and organizational requirements, but 
for no less than six (6) years following the completion of the study. Disposal of records will be 
performed according to regulations. At the conclusion of the study, hard copy data will be 
stored in a locked cabinet in the PI’s locked office until disposal. Digital copies of audio 
recordings will be stored on an HMH password-protected computer until disposal, though 
completed audio recordings will remain online. 

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6.8. Credentials, Training  
All clinicians implementing the intervention will maintain active certification status from the 
Certification Board for Music Therapists. 
6.9. Financing and Insurance 
This study is funded by HMH Carrier Clinic with a grant from the American Music Therapy 
Association. The grant will be disbursed in two installments of $2,471.89, a total of $4943.77. 
HMH Carrier Clinic has agreed to cover the cost of capital improvements, including acoustic 
treatment of the clinical space, up to $5000.00.  
6.10. Publication Plan 
Upon completion of data collection, analysis, and write-up, the study will be submitted for 
publication to a peer-reviewed journal. 
Appendices  
Appendix #  
1 
2 
Name  
Data Collected 
ISMI Questionnaire 
Title  
 
Section  
Topic 
 
Appendix 1: Data collected 
PHI:  Name; DSM-5 category of diagnosis: schizophrenia spectrum and other psychotic 
disorders, bipolar and related disorders, depressive disorders, anxiety disorders, no 
diagnosis 
 
Non-PHI: Participant ID (#); ISMI Score pre-intervention/baseline (#); ISMI Score post-
intervention (#); ISMI Score 3 week follow-up (#) 
 
Appendix 2: ISMI questionnaire 
 
Internalized Stigma of Mental Illness Inventory (ISMI)  
We are going to use the term "mental illness" in the rest of this questionnaire, but please 
think of it as  whatever you feel is the best term for it. For each question, please mark 
whether you strongly  disagree (1), disagree (2), agree (3), or strongly agree (4). 
                                                                                                            Strongly      Disagree       Agree    Strongly
                                                                                                                       Disagree                                          agree 
1. I feel out of place in the world because I have a mental illness.                    1                 2                3               4 
2. Mentally ill people tend to be violent.                                                             1                 2                3               4 
3. People discriminate against me because I have a mental illness.                 1                 2                3               4 
4. I avoid getting close to people who don’t have a mental illness to                 1                 2                3               4  
      avoid rejection. 
5. I am embarrassed or ashamed that I have a mental illness.                          1                 2                3               4 
6. Mentally ill people shouldn’t get married.                                                       1                 2                3               4 
7. People with mental illness make important contributions to society.              1                 2                3              4 
8. I feel inferior to others who don’t have a mental illness.                                 1                 2                3              4 
9. I don’t socialize as much as I used to because my mental illness                  1                 2                3               4 
      might make me look or behave “weird.”  

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10. People with mental illness cannot live a good, rewarding life.                      1                2                 3              4 
11. I don’t talk about myself much because I don’t want to burden                    1                 2                3              4 
        others with my mental illness.  
12. Negative stereotypes about mental illness keep me isolated from               1                 2               3               4 
        the “normal” world.  
13. Being around people who don’t have a mental illness makes me                    1               2               3              4 
        feel out of place or inadequate. 
14. I feel comfortable being seen in public with an obviously mentally                  1               2               3              4 
        ill person. 
15. People often patronize me, or treat me like a child, just because I                  1               2                3             4 
        have a mental illness.  
16. I am disappointed in myself for having a mental illness.                                  1               2                3             4 
17. Having a mental illness has spoiled my life.                                                     1              2                 3            4 
18. People can tell that I have a mental illness by the way I look.                         1               2                 3            4 
19. Because I have a mental illness, I need others to make most                         1               2                 3            4 
        decisions for me.  
20. I stay away from social situations in order to protect my family or                    1              2                  3            4 
        friends from embarrassment. 
21. People without mental illness could not possibly understand me.                    1              2                  3            4 
22. People ignore me or take me less seriously just because I have a                  1               2                 3            4 
        mental illness. 
23. I can’t contribute anything to society because I have a mental                        1               2                 3            4 
        illness.  
24. Living with mental illness has made me a tough survivor.                                1              2                 3            4 
25. Nobody would be interested in getting close to me because I have                 1              2                 3            4 
        a mental illness.  
26. In general, I am able to live my life the way I want to                                     . 1              2                 3            4 
27. I can have a good, fulfilling life, despite my mental illness.                              1               2                 3            4 
28. Others think that I can’t achieve much in life because I have                          1               2                 3            4 
        a mental illness .  
29. Stereotypes about the mentally ill apply to me.                                               1               2                 3             4 
J. Ritsher, University of California, San Francisco. ritsher@itsa.ucsf.edu 
List of Tables  
 
Table 1. Phases of MTAR treatment sequence related to Drapalski et al.’s (2013) model 

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Table 2. Comparison of Photovoice (Russinova, 2014) and MTAR Characteristics and 
Rationale of Divergence 
Table 3. Comparison of “The Stigma Blues” (Silverman, 2013) and MTAR Characteristics 
and Rationale of  Divergence 
Table 4. Study Timeline Per Cohort 
 
Figure 1. Randomization Procedure 
 
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