Recruiting

Observational Study

Sponsor:

Temple University

Code:

NCT06700902

Conditions

Major Depressive Disorder

Bipolar Disorder

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Taking Action

Study Details

Brief summary:

The goal of this research is to investigate whether a peer-delivered illness self-management program called Taking Action can help college students with serious mental illnesses. Participants will be randomly assigned to either the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions. Participants will complete three interviews (baseline, post-intervention, and follow-up) to assess how well the program works, is liked, and benefits students clinically and academically. The investigators seek to test the following hypotheses: Compared to controls, students who do the Taking Action program will report greater improvements in mental health self-management attitudes, skills, and behaviors and will report greater improvements in mental health symptoms and recovery, and better academic outcomes.

Conditions

Major Depressive Disorder

Bipolar Disorder

Schizophrenia

Study ID

NCT06700902

Start date

Sep 1, 2024

Status verified date

Dec, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Currently enrolled in a 2- or 4-year postsecondary educational institution in the United States (and are able to present a valid student ID card)
  • Experiencing a serious mental illness, as operationalized by either:
  • A score of 13 or higher on the K-6 Screening Scale for serious mental illness
  • Self-reported psychiatric diagnosis of schizophrenia-spectrum or major affective disorder and self-reported lifetime functional impairment due to experiencing mental health challenges
  • 18 years of age or older
  • Have consistent access to a computer or smartphone and the Internet for communications
  • No prior WRAP or Taking Action education

Exclusion Criteria:

  • Expected to graduate or complete their program within 2 semesters
  • Unable to provide informed consent

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Taking Action Intervention Condition

Participants in the experimental condition will participate in the Taking Action intervention.

no intervention: Information Only Control Condition

Participants in the information only control condition will not participate in any intervention but will be given access to a resource entitled, "A Practical Guide for People with Disabilities Who Want to Go to College".

Interventions

Taking Action

Participants in the experimental condition will participate in the Taking Action intervention, which will be delivered in a small group format in 5 weekly 2.5 hour videoconferencing sessions. Taking Action will be implemented using materials available on SAMHSA's website (https://www.co.ozaukee.wi.us/DocumentCenter/View/8198/Taking-Action-A-MH-Recovery-Self-Help-Ed-Program?bidId=). The process will include an overview of key recovery and wellness concepts and the development of an individualized wellness toolbox, which is a list of skills and strategies that a person already uses or would like to use to maintain or regain wellness. Then, participants will make plans for monitoring and addressing distressing mental health symptoms. Instructional techniques will include lectures, discussions, personal examples from facilitators and participants own lives to illustrate key concepts related to self-management, individual and group exercises, and voluntary action plans between meetings.

Primary outcome measure

  • Changes from Baseline in Mental Health Symptoms [ Time Frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up ]
  • Changes from Baseline in Perceived Recovery [ Time Frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up ]

Central Contacts and Locations

Central contacts

Elizabeth Thomas, PhD

2152041699elizabeth.thomas@temple.edu

Locations

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19122

More Information

Sponsor

Temple University

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • Taking Action
  • Recovery
  • Wellness
  • Serious Mental Illness
  • College Students

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2025-12-29.