72 Participants Needed

Forging New Paths for Mental Illness

(FNP Trial)

AW
JP
Overseen ByJonathan Phillips, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Forging New Paths (FNP) for mental illness?

The research highlights that using patient-centered approaches, simplifying medication regimens, and offering psychosocial interventions can improve outcomes for schizophrenia, suggesting that similar strategies in the FNP treatment might also be effective for mental illness.12345

What safety data exists for the treatment 'Forging New Paths' (FNP) for mental illness?

The research articles reviewed do not provide specific safety data for the treatment 'Forging New Paths' (FNP) for mental illness.678910

What is the purpose of this trial?

The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question\[s\] it aims to answer are:1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure).2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes)Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records.

Research Team

AW

Amy Wilson, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals with mental health disorders who have had contact with the criminal legal system. They must pass a screening interview to participate. The study will involve those willing to be randomly assigned to either the new intervention, Forging New Paths plus usual care, or to receive usual care alone.

Inclusion Criteria

History of any type of criminal justice system involvement (i.e., arrest, conviction, incarceration, or probation/parole)
Have moderate or higher levels of criminogenic risk factors as determined by the Level of Service and Case Management Inventory (LS/CMI)
I have been diagnosed with schizophrenia, major depression, or bipolar disorder.
See 1 more

Exclusion Criteria

Intellectual or developmental disability
Incarceration at the point of study enrollment
Non-English speakers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive the Forging New Paths intervention in addition to usual care or usual care alone

6 months
3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at 9 months

3 months
1 visit (in-person) at 9 months

Treatment Details

Interventions

  • Forging New Paths
Trial Overview The clinical trial is testing 'Forging New Paths,' an intervention aimed at reducing aggression and increasing community tenure among people with mental illness. It compares this approach against standard care practices by assessing changes in impulsivity and criminal attitudes.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Forging New Paths + Usual CareExperimental Treatment1 Intervention
The experimental condition receives Forging New Paths in addition to community based mental health services as determined by their treatment providers.
Group II: Control: Usual Care AloneActive Control1 Intervention
The control condition receives community based mental health services as determined by their treatment providers.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

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.
Patient-Centered Treatment Strategies to Improve Outcomes in Schizophrenia.Harvey, PD.[2021]
The implementation of an integrated care pathway (ICP) for 224 patients with schizophrenia aimed to improve collaboration between hospital and community mental health services, but showed minimal effectiveness in reducing re-hospitalization rates or inpatient costs.
Despite efforts to enhance compliance with established procedures during hospitalization, significant disagreements between sectors persisted, indicating that the ICP did not achieve its intended goals and led to the phasing out of ineffective initiatives.
[The Alliance Programme: an integrated care pathway for patients with schizophrenia].Nielsen, B., Sigsgaard, A., Gregersen, J., et al.[2019]
The implementation of a clinical care pathway for 114 patients with schizophrenia led to more frequent diagnostic tests and a significant reduction in the number of patients who were over- or undermedicated, indicating improved adherence to treatment guidelines.
Despite these process improvements, the patients' reported outcomes and assessments of their condition worsened after the pathway was implemented, suggesting that the pathway did not translate into better treatment efficacy or patient satisfaction.
The effects of a clinical care pathway for schizophrenia: a before and after study in 114 patients.Steinacher, B., Mausolff, L., Gusy, B.[2022]

References

Patient-Centered Treatment Strategies to Improve Outcomes in Schizophrenia. [2021]
[The Alliance Programme: an integrated care pathway for patients with schizophrenia]. [2019]
The effects of a clinical care pathway for schizophrenia: a before and after study in 114 patients. [2022]
Defining and measuring clinical effectiveness in the treatment of schizophrenia. [2022]
Issues for the development of care pathways in mental health services. [2019]
Number needed to harm: its limitations in psychotropic drug safety research. [2013]
Prevalence, Nature, Severity and Preventability of Adverse Drug Events in Mental Health Settings: Findings from the MedicAtion relateD harm in mEntal health hospitals (MADE) Study. [2022]
The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. [2023]
Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]
Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. [2023]
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