Positive Processes and Transition to Health

(PATH Trial)

Recruiting in Cleveland (>99 mi)

+2 other locations

Overseen By Sinan Payat, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Psychotropics

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests PATH therapy, which helps adults with PTSD or depression from major life events. PATH aims to change negative thoughts, encourage facing problems, and promote positive experiences.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not have an unstable dose of psychotropic medications in the prior 3 months. This suggests that if you are on a stable dose, you may not need to stop.

What data supports the effectiveness of the treatment Positive Processes and Transition to Health (PATH)?

Clinical pathways, which are structured treatment plans, have been shown to reduce hospital stay length and improve patient satisfaction in various settings. This suggests that structured approaches like PATH could potentially enhance patient outcomes by streamlining care processes. ^{1 2 3 4 5}

What safety data exists for the treatment PATH?

The safety of treatments like PATH is often evaluated through adverse events (unintended and harmful events related to medications) in clinical trials. These events are monitored and reported to ensure the treatment is safe for humans, but specific safety data for PATH itself is not provided in the available research. ^{6 7 8 9 10}

Research Team

Norah C Feeny, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

Inclusion Criteria

You have experienced a traumatic event and have at least two of the following symptoms: constantly thinking about the event, avoiding things that remind you of the event, or not enjoying things you used to enjoy.

Destabilizing life event involving profound loss or threat, with a minimum duration of 12 weeks since the event, but occurred within the last 5 years

Between the ages of 18 and 65

Exclusion Criteria

Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan)

Severe self-injurious behavior or suicide attempt within the previous three months

Unstable dose of psychotropic medications in prior 3 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six 60-90 min weekly sessions of PATH therapy, with two booster sessions for partial responders

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

Treatment Details

Interventions

• Positive Processes and Transition to Health (PATH)

Participant Groups

Group I: receive PATH therapy Experimental Treatment 1 Intervention

PATH includes six 60-90 min, weekly sessions, with two booster sessions for partial responders. Session 1 provides the PATH rationale and a review of life events (PATH of life: negative and positive). A rationale for an explicit focus on positive events/emotions will be provided. Sessions 2-4 focus on a verbal narrative of the destabilizing life event, reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. Sessions 5 focuses on constructive processing and provides opportunity for integration and consolidation of learning. Session 6 focuses on future negative and positive events to promote application of new learning and resilience. Booster sessions focus on positive and negative life events since the last session and adaptive processes (constructive processing, approach, and reward). All sessions will include cultivation and elaboration of positive emotions to promote engagement and to build on the benefits of positive emotions.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

Findings from Research

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Clinical pathways and patient-related outcomes in hospital-based settings: a systematic review and meta-analysis of randomized controlled trials. [2021]

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

Process Improvement in Patient Pathways: A Case Study Applying Accelerated Longitudinal Design With Decomposition Method. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Evaluating the Navigate Care Model: clinical palliative care pathways based on anticipated care outcomes. [2015]

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

Using variance tracking to improve outcomes and reduce costs. [2019]

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

One-year experience with an inpatient asthma clinical pathway. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Statistical Considerations on the Evaluation of Imbalances of Adverse Events in Randomized Clinical Trials. [2020]

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

Adverse drug events: identification and attribution. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Analysis and reporting of adverse events in randomised controlled trials: a review. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Why Clinicians Don't Report Adverse Drug Events: Qualitative Study. [2019]

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

Measurement of adverse events using "incidence flagged" diagnosis codes. [2018]