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Mental IllnessNCT05784818

Up To Me: Erasing the Stigma of Mental Illness on College Campuses

A study testing Up To Me Intervention + No Booster and Up To Me Intervention + Booster in people with Mental Illness and Behavior Disorders, run by University of South Florida at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a three-lesson, disclosure-based stigma reduction program meant to reduce barriers to community living and participation for college students with psychiatric disabilities. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Up To Me Intervention + No Booster and Up To Me Intervention + Booster
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
1 siteUnited States
Study dates
7 Mar 2022to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • College students enrolled at USF
  • Over 18 years of age
  • Individuals with psychiatric disability(ies) who feel shame regarding their mental illness or keep it secret

Who cannot join

  • Individuals with a sole substance abuse disorder
  • Individuals who plan to graduate before the conclusion of the data collection period; for intervention participants, this would be a graduation date within 6 months of starting the intervention.

Trial locations and contacts

1 site in 1 country.

Kristin Kosyluk, PhD contact

813-974-6019

kkosyluk@usf.edu

United States1 site, 1 recruiting

  • University of South Florida

    Tampa, Florida, 33620

    Kristin Kosyluk, PhD, 813-974-6019, kkosyluk@usf.edu

    Tempestt Neal, PhD

    Recruiting

Other trials in United States

About this study

This is a three-lesson, disclosure-based stigma reduction program meant to reduce barriers to community living and participation for college students with psychiatric disabilities. The goal is to improve community living and participation of individuals with psychiatric disabilities within their postsecondary community using the Honest Open Proud (HOP) program. There are 3 specific objectives of the project:1) evaluate program fidelity, 2) assess program feasibility, and 3) conduct a randomized controlled trial of the HOP program with college students with mental illness to examine its efficacy. Anticipated outcomes include increases in 1) community integration, 2)self-esteem and self-efficacy, 3) empowerment and self-determination, 4) disclosure of mental illness in order to obtain needed support, and 5) care seeking/service engagement for mental illness. Ultimately, we expect to see increased academic persistence and achievement among HOP program completers.

Being tested
Up To Me Intervention + No Booster, Up To Me Intervention + Booster
Keywords
mental illness, disclosure, empowerment, stigma
Medical subject headings
Mental Disorders, Empowerment, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Up To Me Intervention + No BoosterBehavioural

    Participants will complete two-hour sessions once a week over three weeks in which they complete modules in the Up To Me Workbook. These sessions are facilitated by a peer facilitator and a member of the USF Counseling center. Other members in the group sessions are university students who are peers who are also experiencing some form of shame around their mental health challenges.

  • Up To Me Intervention + BoosterBehavioural

    In addition to the Up To Me Intervention, participants also complete a booster/additional session where additional topics of the Up To Me workbook are covered. This additional session occurs four weeks after the completion of the third session.

Study groups in NCT05784818
Study groupRoleWhat they receive
Intervention + No BoosterExperimentalThis arm will have n=67 participants. The Up To Me behavioral intervention will be administered via 2-hour sessions over three consecutive weeks. During these sessions, participants will complete worksheets from the Up To Me workbook.
Receives: Behavioral: Up To Me Intervention + No Booster
Intervention + BoosterExperimentalThis arm will have n=67 participants. The Up To Me behavioral intervention will be administered via 2-hour sessions over three consecutive weeks. During these sessions, participants will complete worksheets from the Up To Me workbook. Additionally, participants randomized to this arm will complete an additional session 4 weeks after the third session of the intervention.
Receives: Behavioral: Up To Me Intervention + Booster
Waitlist ControlNo interventionThis arm will have n=67 participants. Those randomized to this arm will be engaged in "treatment as usual", participating in the same services and activities that they were engaged with prior to recruitment into the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Stigma of Mental Illness Scale-Short Form

    Scores correspond with the four stage regressive model of self-stigma. The min of this scale is 1 or "I strongly disagree" and the max is 9 or "I strongly agree". Using this scale, an observed decrease would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  2. Stigma Stress Scale

    This scale includes 4 items measuring appraisal of stigma as a stressor (e.g., "prejudice against people with mental illness will have a negative impact on my future") and 4 items measuring perceived resources to cope with stigma (e.g., "I am prepared to deal with prejudice against people with mental illness"). The min on the scale is 1 or "Strongly disagree" to 7 or "Strongly agree". Using this scale, an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  3. Why Try Stigma Scale (WTSS)

    The current version of the WTSS does not include items specific to the pursuit of postsecondary education. Therefore, the investigators will add two items for the purpose of this study: "I am not worthy of obtaining a college degree because I have a mental illness" and "I am not capable of obtaining a college degree because I have a mental illness." After the addition of the two aforementioned items, this scale includes 16 items on a seven-point agreement scale. The min on the scale is 1 or "Strongly disagree" to 7 or "Strongly agree". Using this scale, an observed decrease would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  4. The Empowerment Scale

    Yields five factors: self-efficacy/self-esteem, power/powerlessness/community activism, righteous anger, and optimism/control over the future. This scale includes 28 items on a 4-point agreement scale. The min on the scale is 1 or "Strongly Disagree" to the max of 4 or "Strongly Agree". Using this scale, an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  5. Self-Determination Scale

    Participants respond to a vignette about a person, Harry, living with schizophrenia. The scale includes 14 items on a 9-point agreement scale. The minimum on the scale is 1 or "Strongly Agree" to 9 or "Strongly Disagree". Using this scale, an observed decrease would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

Secondary outcomes (18)

  1. College Student Experiences Questionnaire (CSEQ Fourth Edition)

    Following the design of the study conducted by Salzer examining the postsecondary experiences of students with psychiatric disabilities, the investigators will administer several scales from the CSEQ. The CSEQ assesses student campus experiences and engagement, relationships with others on campus, and the degree of satisfaction with their experience at a particular institution.

    Three indicators of academic integration will be included in this study. The first, Quality of Effort (QE), refers to the underlying assumption of the CSEQ: "The more effort students expend in using the resources and opportunities an institution provides for their learning and development, the more they benefit." This scale has 22 items on a 4-point frequency scale. The minimum on the scale is 1 or "Never" to the max (4) or "Very Often". Using this scale, an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  2. Peer Group Interactions Scale

    The Peer-Group Interactions Scale is a subscale of Pascarella and Terenzini's scale assessing the academic and social considerations in student persistence.

    This scale has 7 items on a 7-point agreement scale. The min on the scale is 1 or "Strongly Disagree" to the max (7) or "Strongly Agree". Using this scale, an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  3. Interactions with Faculty Scale

    The Interactions with Faculty Scale is a subscale of Pascarella and Terenzini's scale assessing the academic and social considerations in student persistence; this scale focuses on assessing the quality of faculty interactions.

    This scale has 5 items on a 7-point agreement scale. The min on the scale is 1 or "Strongly Disagree" to the max (7) or "Strongly Agree". Using this scale, an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  4. Sense of Campus Belonging Scale (SoCB)

    Sense of belonging is a psychological construct unique from engagement and integration, focusing on students' subjective feelings of connectedness. Hurtado and Carter developed a measure of cohesion including a subscale of sense of belonging including items concerning perceived "belonging," "fit," and being a "part" of the community.

    Each of the three items on the SoCB scale is rated on an 11-point Likert scale with a min of 0 or "Strongly DIsagree to the max (10) "Strongly agree". Using this scale, an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  5. Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPHS)

    The Attitudes Towards Seeking Professional Psychological Help Scale measures attitudes towards seeking help for mental health concerns from professional sources.

    This scale has 10 items on a 4-point agreement scale with a min of 1 or "Disagree" to a max of 4 "Agree". Using this scale, an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  6. Actual Help Seeking Questionnaire

    The Actual Help Seeking Questionnaire (AHSQ) assesses recent help-seeking behavior and was adapted from Rickwood and Braithwaite. The AHSQ has been successfully used to measure help-seeking across different time contexts, sources of help, and types of problems. Recent help-seeking behavior is determined by listing a number of potential help sources and asking whether or not help has been sought from each of the sources during a specified period of time for a specified problem.

    This questionnaire has 14 items that represent sources of help-seeking. Using this questionnaire, an observed increase in sources used would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  7. Grade Point Average (GPA)

    GPA will be retrieved from University records at all measurement time points (baseline, post-test, and 1, 3, and 6- month follow-up). Students will be asked to sign a release form consenting that their GPA records be released to the study investigators. The investigators do realize GPA may lack sensitivity to change over time, however, the investigators include this variable as previous research in higher education has captured change over relatively short time periods (one to two years).

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  8. Academic and Intellectual Development Scale

    The Academic and Intellectual Development Scale is a subscale of Pascarella and Terenzini's scale assessing the academic and social considerations in student persistence; it focuses on assessing satisfaction with the institution's academics.

    This scale has 7 items on a 7-point agreement scale with a min of 1 or "Strongly Disagree" to a max of 7 or "Strongly Agree". Using this scale, an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  9. Academic Persistence

    Data on student registration status will be retrieved from University records at all measurement time points. Data on actual persistence will be coded: 1= withdrawal, 2= persisted. The investigators will ask students to sign a release consenting that their enrollment records be released to the study investigators.

    Intent to persist will be measured using a single item: "It is likely that I will re-enroll in the university next semester" (5= strongly agree, 1= strongly disagree). An observed increase would be a better outcome.

    In order to capture persistence and achievement over the entire course of the project (after 6-month follow-up is complete, The investigators will continue to collect data from the University records at five-month intervals (approximately once every semester) until the end of the project period. The investigators will request consent from all students to access these records.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  10. Counseling Center Assessment of Psychological Symptoms

    Collecting this data will allow us to control for symptom severity in our analyses. These measures were selected as they have strong psychometric properties and sensitivity to change, require minimal time to complete, and are also the assessments administered to all students receiving services at USF where the study will take place.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  11. Diagnostic and Status Questionnaire

    In addition to the Counseling Center tools, the investigators will provide the opportunity for participants to self-report diagnosis and disability. This tool was developed by the National Center for Science Education for patient self-report.

    This questionnaire assesses impairment symptoms on a 7-point scale with a min of 1 or "Not at all impaired" to a max of 7 (Very much impaired). Using this scale, a low score would be a better outcome.

    Measured: This measure will be collected at week 0 for all participants

  12. Diagnostic and Status Questionnaire Past 4 weeks

    In addition to the Counseling Center tools, the investigators will provide the opportunity for participants to self-report diagnosis and disability. This tool was developed by the National Center for Science Education for patient self-report.

    This questionnaire assesses impairment symptoms on a 7-point scale with a min of 1 or "Not at all impaired" to a max of 7 (Very much impaired). Using this scale, an observed decrease would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  13. Behavioral Health Measure

    Collecting this data will allow us to control for symptom severity in our analyses. These measures were selected as they have strong psychometric properties and sensitivity to change, require minimal time to complete, and are also the assessments administered to all students receiving services at USF where the study will take place.

    This measure has 20 items on a 5-point scale with a min 0 and a max of 5. For seven items, a score of 5 is a high and positive rating. For these items, an observed increase over time would be a better outcome. For the remaining items, a score of 5 is a high rating of distress and an observed decrease would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  14. Recovery Assessment Scale

    The Recovery Assessment Scale (RAS) is a 24-item measure based on a process model of recovery, the RAS attempts to assess aspects of recovery with a special focus on hope and self-determination.

    These items are measured on a 5-point agreement scale with a min of 1 or "strongly disagree" to a max of 5 or "strongly agree". Using this scale an observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  15. Quality of Relationships Scale

    A 3-item scale that measures the quality of an individual's relationship with a specific person.

    Items are measured on a 7-point rating scale with a min of 1 and max of 7. Where 1 is a low rating of the relationship quality and 7 is a high rating. An observed increase would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

  16. Up To Me Satisfaction Scale

    This scale assesses participants' satisfaction with and feedback for the team regarding the primary intervention of the study. This measure is not being used to measure observed changes. The investigators are interested in the participants' satisfaction with the intervention.

    This scale includes 6 items on a 7-point agreement scale with a min of 1 or "Highly Agree" and a max of 7 or "Highly Disagree".

    Measured: This measure will be collected at week 7 if in the Up To Me Intervention + Booster or Up To Me Intervention + No Booster arms

  17. Demographics Questionnaire

    Provides background information on participants regarding their identities and experiences. This questionnaire is not being used to measure observed changes but to describe the study sample.

    Measured: This measure will be collected at week 0 for all participants

  18. Peer Support and Advocacy Items

    This scale was developed by the study investigators and is comprised of four items inquiring about the participant's involvement in organizations related to peer support or advocacy for mental illness.

    An observed increase in involvement would be a better outcome.

    Measured: Change from baseline to week 3, week 7, week 15 and 27 for all participants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start7 Mar 2022
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion30 Mar 2024 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
201 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784818
Sponsor's protocol ID
90IFRE0056-01-00
Status last verified
Aug 2022
First submitted
13 Dec 2022
Last updated
27 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Final data sets will be stored on the secure server of the USF Policy and Services Research Data Center. Others interested in accessing the data will be instructed to contact the PI, Dr. Kosyluk, or Co-I, Dr. Neal, and arrangements will be made to transfer the files via the FTP mentioned above. Information on the data sets will also be hosted on the website of the Temple University Collaborative on Community Inclusion (Salzer, PI) and the National Consortium on Stigma and Empowerment (Corrigan, Director). Drs. Kosyluk and Neal will include information about the data sets and how to access them on their USF Faculty profiles and respective research lab websites. Data will be available for sharing no sooner than one year after the completion of the study. There will be no cost associated with accessing the data files.

Publications

  • Salzer MS. A comparative study of campus experiences of college students with mental illnesses versus a general college sample. J Am Coll Health. 2012;60(1):1-7. doi: 10.1080/07448481.2011.552537.

    PubMed 22171723

  • Gonyea, R.M., Kish, K.A., Kuh, G.D., Muthiah, R.N., & Thomas, A.D. (2003). College Student Experiences Questionnaire: Norms for the Fourth Edition. Bloomington: Indiana University Center for Postsecondary Research, Policy, and Planning.

  • Pascarella, E. T., & Terenzini, P. T. (2005). How college affects students: A third decade of research (Vol. 2).

  • Hurtado, S., & Carter, D. F. (1997). Effects of college transition and perceptions of the campus racial climate on Latino college students' sense of belonging. Sociology of education, 324-345.

  • Jones, N., Brown, R., Keys, C. B., & Salzer, M. (2015). Beyond symptoms? Investigating predictors of sense of campus belonging among postsecondary students with psychiatric disabilities. Journal of Community Psychology, 43(5), 594-610. https://doi.org/10.1002/jcop.21704

  • Rickwood DJ, Braithwaite VA. Social-psychological factors affecting help-seeking for emotional problems. Soc Sci Med. 1994 Aug;39(4):563-72. doi: 10.1016/0277-9536(94)90099-x.

    PubMed 7973856

  • Rickwood, D., Deane, F. P., Wilson, C. J., & Ciarrochi, J. (2005). Young people's help- seeking for mental health problems. Advances in Mental Health, 4(3), 218-251.

  • Bean, J. P. (1980). Dropouts and turnover: The synthesis and test of a causal model of student attrition. Research in higher education, 12(2), 155-187.

  • Bers, T. H., & Smith, K. E. (1991). Persistence of community college students: The influence of student intent and academic and social integration. Research in higher Education, 32(5), 539-556.

  • Milem, J. F., & Berger, J. B. (1997). A modified model of college student persistence: Exploring the relationship between Astin's theory of involvement and Tinto's theory of student departure. Journal of college student development, 38(4), 387.

Questions about this trial

What is this clinical trial studying?

A study testing Up To Me Intervention + No Booster and Up To Me Intervention + Booster in people with Mental Illness and Behavior Disorders, run by University of South Florida 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kristin Kosyluk, PhD (813-974-6019, kkosyluk@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Stigma of Mental Illness Scale-Short Form (time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05784818, which also lists 10 linked publications.

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 27 Mar 2023.

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