Taking Action Program for Serious Mental Illnesses

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Temple University

Disqualifiers: Graduating soon, Unable to consent

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Taking Action Program for Serious Mental Illnesses?

The research suggests that patient-centered approaches, which include simplifying medication regimens and using shared decision-making, can improve outcomes for people with schizophrenia. These strategies, along with psychosocial interventions, are part of effective treatments for serious mental illnesses. ^{1 2 3 4 5}

How is the Taking Action Program treatment different from other treatments for serious mental illnesses?

The Taking Action Program is unique because it focuses on integrating mental health care with general medical care, addressing both psychiatric and physical health needs, which is often overlooked in traditional treatments for serious mental illnesses. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Taking Action (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Kumar Budur

Temple University

Chief Medical Officer

MD, MS

Dr. Jeffrey M. Dayno

Temple University

Chief Executive Officer

MD from Temple University School of Medicine

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Dr. Kristi Hill

National Institute on Disability, Independent Living, and Rehabilitation Research

Acting Director since 2012

PhD in Neuroscience from the Medical College of Virginia

Dr. Phillip Beatty

National Institute on Disability, Independent Living, and Rehabilitation Research

Director of the Office of Research Sciences since 2019

PhD in Rehabilitation Sciences

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Evidence-based treatment of schizophrenia. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Performance in Practice: Practice Assessment Tool for the Care of Patients With Schizophrenia. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Policy Definitions for "Serious Mental Illness" Across 56 United States, Districts and Territories. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Multiple risk-behavior profiles of smokers with serious mental illness and motivation for change. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Financial incentives and accountability for integrated medical care in Department of Veterans Affairs mental health programs. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Refining a taxonomy of goals planned between mental health consumers and community pharmacists. [2023]

10. United States 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. [2018]