NCT05784818

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

March 27, 2023

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

December 13, 2022

Last Update Submit

March 13, 2023

Conditions

Keywords

mental illnessdisclosureempowermentstigma

Outcome Measures

Primary Outcomes (5)

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (18)

  • College Student Experiences Questionnaire (CSEQ Fourth Edition)

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

  • Peer Group Interactions Scale

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

  • Interactions with Faculty Scale

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

  • Sense of Campus Belonging Scale (SoCB)

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

  • Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPHS)

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

  • +13 more secondary outcomes

Study Arms (3)

Intervention + No Booster

EXPERIMENTAL

This 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.

Behavioral: Up To Me Intervention + No Booster

Intervention + Booster

EXPERIMENTAL

This 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.

Behavioral: Up To Me Intervention + Booster

Waitlist Control

NO INTERVENTION

This 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.

Interventions

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.

Intervention + No Booster

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.

Intervention + Booster

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Related Publications (10)

  • 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.

    PMID: 22171723BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 7973856BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Mental DisordersEmpowermentSocial Stigma

Interventions

Immunization, Secondary

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

ImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Kristin Kosyluk

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Kosyluk, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

March 27, 2023

Study Start

March 7, 2022

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

March 27, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Data will be available for sharing no sooner than one year after the completion of the study.
Access Criteria
A contractual agreement will be developed on a case-by-case basis if data are requested by a certified researcher. The restriction will be based on the provision of data that cannot be linked to identifiers, either directly or by deduction. Thus, the precise content of each data-sharing plan will vary, will be developed in collaboration with investigators requesting the data, and will be a formal, written agreement. The agreement will specify: Which named researchers have access to the data, what research questions they will examine, what analyses they will do, how they will dispose of the data after analysis, which specific conditions are placed on the use of the data, procedures for maintaining protection of confidentiality of participants, the timeline for publication of results, and details of research collaboration if relevant (e.g. tasks of each group, authorship, etc.).
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