Recruiting

Observational Study

Sponsor:

University of South Florida

Code:

NCT05784818

Conditions

Mental Illness

Behavior Disorders

Severe Mental Illness

Psychiatric Diagnosis

Psychiatric Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Up To Me Intervention + No Booster

Up To Me Intervention + Booster

Study Details

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.

Conditions

Mental Illness

Behavior Disorders

Severe Mental Illness

Psychiatric Diagnosis

Psychiatric Diseases

Study ID

NCT05784818

Start date

Mar 7, 2022

Status verified date

Aug, 2022

Completion date

Mar 30, 2024

Anticipated

Primary completion date

Mar 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

201 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention + No Booster

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.

experimental: Intervention + Booster

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.

no intervention: Waitlist Control

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

Up To Me Intervention + No Booster

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 + 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.

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 ]
  • Stigma Stress Scale [ Time Frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants ]
  • Why Try Stigma Scale (WTSS) [ Time Frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants ]
  • The Empowerment Scale [ Time Frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants ]
  • Self-Determination Scale [ Time Frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants ]

Central Contacts and Locations

Central contacts

Kristin Kosyluk, PhD

813-974-6019kkosyluk@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33620

Contacts

Kristin Kosyluk, PhD

813-974-6019kkosyluk@usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Mar 27, 2023

Last verified

Aug, 2022

Keywords

  • mental illness
  • disclosure
  • empowerment
  • stigma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2023-03-27.