Taking Action Program for Serious Mental Illnesses

Overseen By Elizabeth Thomas, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Disqualifiers: Graduating soon, Unable to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 5 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a program called Taking Action can help college students better manage serious mental illnesses. Participants will either attend Taking Action sessions or receive only useful information. The goal is to determine if Taking Action improves mental health and academic performance. College students in the U.S. with conditions like schizophrenia or major depressive disorder, who have faced significant challenges due to mental health, might be a good fit. Participants must have regular access to a computer or smartphone.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance mental health support for college students.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a self-management program rather than medication changes.

What prior data suggests that the Taking Action program is safe for college students with serious mental illnesses?

Studies have shown that community-based social programs, like the Taking Action program, are generally safe for people with serious mental illnesses. These programs aim to improve skills and attitudes without medications, reducing the risk of side effects. Research indicates that such programs are well-tolerated, with few reports of negative effects.

For the Taking Action program specifically, previous studies do not provide direct safety data. However, because it involves educational sessions and peer support rather than medication or medical procedures, it is likely safe for participants. This type of program helps individuals manage their mental health through learning and support, which tends to be safe and supportive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Taking Action program because it offers a fresh approach to supporting individuals with serious mental illnesses, focusing on empowerment and personal growth. Unlike traditional treatments that often rely on medication or talk therapy, this intervention emphasizes proactive engagement and skill-building, aiming to equip participants with practical tools for navigating life challenges. By incorporating strategies tailored to enhance self-efficacy and independence, the program could potentially address gaps left by standard care methods, offering a more holistic path to mental health improvement.

What evidence suggests that the Taking Action program is effective for serious mental illnesses?

Research has shown that programs like Taking Action, which participants in this trial may receive, can assist individuals with serious mental health issues. Similar programs have led to better personal recovery, improved mental health management, and enhanced social skills. Studies on mental health treatments have found they can reduce symptoms and increase hope for participants. For college students, peer-led programs have effectively improved mental health and reduced stigma. These findings suggest that Taking Action could help students manage their mental health better and succeed in their studies. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for college students who have serious mental illnesses such as Bipolar Disorder, Depression, or Schizophrenia. Participants should be willing to attend sessions and complete interviews. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

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

Have consistent access to a computer or smartphone and the Internet for communications

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)

Exclusion Criteria

I am unable to understand or sign the consent form.

Expected to graduate or complete their program within 2 semesters

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental condition attend five 2.5-hour Taking Action sessions delivered online via videoconferencing

5 weeks

5 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Taking Action

Trial Overview The study tests 'Taking Action,' a peer-delivered self-management program. Students will either join this program or receive only information (control group). The effectiveness of the program on mental health and academic performance will be evaluated through interviews.

How Is the Trial Designed?

Group I: Taking Action Intervention Condition Experimental Treatment 1 Intervention

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

Group II: Information Only Control Condition Active Control 1 Intervention

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".

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

Only 36% of mental health programs felt primarily responsible for monitoring diabetes and cardiovascular risks in patients on second-generation antipsychotics, indicating a gap in accountability for general medical conditions.

Financial incentives significantly increased the likelihood of programs taking responsibility for diabetes and cardiovascular screenings, suggesting that such incentives could enhance the quality of care in mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial incentives and accountability for integrated medical care in Department of Veterans Affairs mental health programs. Kilbourne, AM., Greenwald, DE., Hermann, RC., et al.[2017]

New antipsychotic medications offer hope for improved outcomes in individuals with schizophrenia, focusing on recovery rather than just maintenance of symptoms.

The article presents a framework for understanding the diverse outcomes of long-term psychosis treatment, which can help in creating more effective treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an outcomes-oriented approach for the treatment of schizophrenia. Lehman, AF.[2019]

A study evaluating the definitions of 'serious/severe mental illness' (SMI) across the U.S. found that 82.2% of locations had available policy definitions, highlighting a significant focus on this issue in mental health initiatives.

There is considerable variability in how SMI is defined, with most locations emphasizing functional impairment as a criterion, but only a small percentage linking these definitions to eligibility for specific mental health services, which could affect access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Policy Definitions for "Serious Mental Illness" Across 56 United States, Districts and Territories. Gonzales, L., Kanani, A., Pereyra, A.[2023]

A patient-centered approach to treating schizophrenia, which includes simplifying medication regimens and involving patients in decision-making, can lead to improved clinical and functional outcomes.

Incorporating psychosocial interventions alongside medication may further enhance the effectiveness of treatment for individuals with schizophrenia, addressing their cognitive, behavioral, and emotional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Treatment Strategies to Improve Outcomes in Schizophrenia. Harvey, PD.[2021]

Patients with severe mental illnesses experience higher health risks and shorter life spans compared to the general population, largely due to modifiable risk factors and a fragmented healthcare system.

There is a need for professional societies to create guidelines for monitoring these health risks and for mental health providers to enhance the integration of primary and mental health care to address these issues effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a health care team to manage chronic medical illnesses in patients with severe mental illness: the public policy perspective. Kane, JM.[2018]

In a study of 693 adult smokers with serious mental illness, participants exhibited an average of 5.2 behavioral risk factors, including smoking, poor diet, and physical inactivity, highlighting the need for comprehensive health interventions.

The research identified distinct risk groups among participants, with the 'global higher risk group' showing the most severe mental health issues and the greatest number of risk behaviors, suggesting that personalized treatment strategies could enhance health outcomes for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple risk-behavior profiles of smokers with serious mental illness and motivation for change. Prochaska, JJ., Fromont, SC., Delucchi, K., et al.[2021]

Evidence-based interventions for schizophrenia, including medication management, illness self-management training, and family psychoeducation, have been shown to significantly improve patient outcomes.

Despite the proven effectiveness of these interventions, they are often not provided in routine mental health settings, highlighting a critical need for better implementation of these treatments in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based treatment of schizophrenia. Drake, RE., Mueser, KT., Torrey, WC., et al.[2019]

In a study involving 38 patients with schizophrenia, overall physical health was identified as the most important outcome domain for patients to communicate with their mental health providers.

This preference for prioritizing physical health was consistent across various factors, including symptom severity and age, suggesting that treatment interventions should address physical health alongside mental health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ranking of outcome domains for use in real-time outcomes feedback laboratory by patients with schizophrenia. Pyne, JM., Labbate, C.[2022]

Many individuals with schizophrenia do not receive the evidence-based treatments they need, despite extensive research on effective pharmacological and nonpharmacological options.

The American Psychiatric Association's updated Practice Guideline aims to improve the quality of care for schizophrenia by promoting the appropriate use of interventions and providing tools for systematic practice improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance in Practice: Practice Assessment Tool for the Care of Patients With Schizophrenia. Fochtmann, LJ., Medicus, J., Hong, SH.[2023]

A study involving 158 participants with severe and persistent mental illnesses identified 512 individualized health-related goals, which were categorized into five domains, demonstrating the diversity of health behaviors targeted in goal planning.

The existing goal taxonomy was successfully refined and validated, showing significant overlap with participant goals, indicating its applicability across various mental health conditions and enhancing the support provided by community pharmacists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refining a taxonomy of goals planned between mental health consumers and community pharmacists. Stewart, V., McMillan, SS., Hu, J., et al.[2023]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06700902/taking-action-for-college-students

Taking Action for College Students | Clinical Research Trial ... The purpose of this study is to assess the feasibility, acceptability, and effectiveness associated with Taking Action for college students with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10714715/

Participatory Action Research Among People With Serious ... Participatory action research (PAR) is a research approach that creates spaces for marginalized individuals and communities to be co-researchers ...

3. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05612-7

Mental health interventions for individuals with serious mental ... The goal of this review was to identify and describe: (1) effectiveness of mental health interventions for individuals with serious mental ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10225549/

Effectiveness of Illness Management and Recovery ... Fourteen studies were included in this review, and eight outcomes were examined: personal recovery, global functioning, social functioning, hope ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212657021000209

Evaluation of a youth mental health literacy and action ... There are promising outcomes and effectiveness from youth MHL and action programs in promoting positive mental health and reducing mental illness stigma.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8751572/

Community‐based social interventions for people with severe ... Improving work outcome in supported employment for serious mental illness: results from 2 independent studies of errorless learning.

7. samhsa.gov samhsa.gov/mental-health/serious-mental-illness/about

Serious Mental Illness and Serious Emotional Disturbances Effective treatments for serious mental illnesses are available in your area. The earlier that you begin treatment, the greater likelihood of a ...

8. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/098651399f829e0c4cd561157ec82e23/aot-grant-program-smi-outcome-report.pdf

Evaluation of the Assisted Outpatient Treatment Grant ... Specifically, program outcomes data were examined using pre-post and comparison group regression analyses, supplemented with Bayesian methods. In addition to ...

9. medicaid.gov medicaid.gov/medicaid/section-1115-demonstrations/serious-mental-illness-section-1115-demonstration-opportunity

Serious Mental Illness Section 1115 Demonstration ... Through these demonstrations, states will focus on demonstrating improved care for individuals with serious mental health conditions in inpatient or residential ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9360426/

Mental Health Prevention and Promotion—A Narrative ... In the current review, we aimed to synthesize existing literature on various mental health promotion and prevention interventions and their effectiveness.