Forging New Paths for Mental Illness

(FNP Trial)

Overseen By Jonathan Phillips, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Intellectual disability, Incarceration, Non-English speakers

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

72 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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.

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

Group I: Experimental: Forging New Paths + Usual Care Experimental Treatment 1 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 Alone Active Control 1 Intervention

The control condition receives community based mental health services as determined by their treatment providers.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a clinical care pathway for schizophrenia: a before and after study in 114 patients. Steinacher, B., Mausolff, L., Gusy, B.[2022]

A consensus among schizophrenia researchers identified four key outcome domains for measuring clinical effectiveness: symptoms of disease, treatment burden, disease burden, and health and wellness.

The Global Outcome Assessment of Life in Schizophrenia (GOALS) was developed as a clinical tool to objectively measure these domains, aiming to enhance treatment expectations beyond just symptom control to include functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and measuring clinical effectiveness in the treatment of schizophrenia. Nasrallah, HA., Targum, SD., Tandon, R., et al.[2022]

The study highlights the need for individualized care pathways for inpatients with schizophrenia, as opposed to a one-size-fits-all approach, emphasizing the importance of tailoring treatment to each patient's unique needs.

Key barriers to developing effective care pathways for mental health services were identified, including the necessity for workforce consent and commitment, indicating that successful implementation will require addressing these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues for the development of care pathways in mental health services. Jones, A., Kamath, PD.[2019]

The 'number needed to harm' (NNH) metric has significant limitations in assessing the risks of adverse drug events (ADEs) from psychotropic medications, including arbitrary cutoffs and limited adjustments for confounding factors.

Postmarketing surveillance using case-control studies offers more reliable data on serious ADEs compared to the NNH, highlighting the need for better risk assessment methods in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Number needed to harm: its limitations in psychotropic drug safety research. Safer, DJ., Zito, JM.[2013]

In a study of 227 patient admissions across three mental health trusts, the rate of confirmed adverse drug events (ADEs) was found to be 12.6 per 100 admissions, with nearly 20% of these events deemed preventable, highlighting a significant safety concern in mental health settings.

The majority of ADEs were linked to medications affecting the central nervous system, particularly antipsychotics and antidepressants, and longer hospital stays increased the risk of experiencing an ADE, indicating a need for targeted interventions to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Alshehri, GH., Ashcroft, DM., Nguyen, J., et al.[2022]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

References

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

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

2. Denmark pubmed.ncbi.nlm.nih.gov

[The Alliance Programme: an integrated care pathway for patients with schizophrenia]. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

The effects of a clinical care pathway for schizophrenia: a before and after study in 114 patients. [2022]

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

Defining and measuring clinical effectiveness in the treatment of schizophrenia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Issues for the development of care pathways in mental health services. [2019]

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

Number needed to harm: its limitations in psychotropic drug safety research. [2013]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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]

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

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. [2023]

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

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. [2023]