PATH Therapy for Post-Traumatic Stress Disorder

(PATH Trial)

No longer recruiting at 2 trial 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Positive Processes and Transition to Health (PATH) to determine its effectiveness for individuals who have experienced a traumatic event and are dealing with PTSD (post-traumatic stress disorder) or depression. The goal is to assess whether PATH can reduce unproductive thinking, avoidance, and difficulties in feeling positive about life. Participants will attend six therapy sessions, with the possibility of two additional sessions if needed. The trial seeks adults who have faced a major loss or threat in the past five years and continue to experience stress or sadness. As an unphased trial, this study offers a unique opportunity to contribute to developing new therapeutic approaches for PTSD and depression.

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 prior data suggests that PATH therapy is safe?

Research has shown that the Positive Processes and Transition to Health (PATH) therapy is generally manageable for participants. Other studies have reported no serious side effects, which are unexpected and harmful reactions, suggesting that the therapy is safe for most people. PATH emphasizes positive feelings and experiences, which can help reduce stress-related symptoms. This focus likely contributes to its safety and positive reception among participants. Although specific sources do not mention side effects, the absence of serious issues in similar studies is encouraging for potential trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Positive Processes and Transition to Health (PATH) approach because it emphasizes harnessing positive emotions and events to foster resilience and mental well-being. Unlike traditional therapies that often focus primarily on negative experiences and symptom reduction, PATH integrates positive life events and emotions into its sessions to promote broader emotional engagement and growth. This innovative focus on cultivating positive emotions and their benefits is believed to enhance engagement and encourage lasting changes, potentially improving outcomes for individuals undergoing therapy.

What evidence suggests that PATH therapy is effective for PTSD and depression?

Studies have shown that Positive Processes and Transition to Health (PATH) therapy, which participants in this trial will receive, helps individuals with PTSD and depression by altering negative thoughts and fostering a positive outlook. Research indicates that PATH can reduce dropout rates and enhance participation in therapy. It addresses unhelpful thoughts and avoidance behaviors while promoting positive experiences. Early findings suggest PATH therapy could lead to better outcomes for those undergoing major life changes. Although more data is needed, PATH shows promise in managing stress and depression symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Norah C Feeny, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Positive Processes and Transition to Health (PATH)

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06093906

Positive Processes and Transition to Health (PATH) PATH has the potential to reduce dropout, improve treatment engagement and outcomes, identify potential treatment mechanisms, and ultimately reduce the ...

2. withpower.com withpower.com/trial/phase-depression-9-2021-a2c9e

Positive Processes and Transition to Health (PATH 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04678232

NCT04678232 | Positive Processes and Transition to Health PATH has the potential to reduce dropout, improve treatment engagement and outcomes, identify potential treatment mechanisms, and ultimately reduce the ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06093906/positive-processes-and-transition-to-health-path?state=DE&city=Neward

Positive Processes and Transition to Health (PATH) PATH has the potential to reduce dropout, improve treatment engagement and outcomes, identify potential treatment mechanisms, and ultimately ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06900712

NCT06900712 | Positive Processes and Transition to Health This research will explore whether this new psychotherapy reduces sexual assault related distress, including posttraumatic stress and depression symptoms. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10174277/

Positive Affect Processes and Posttraumatic Stress ... Findings suggest that PPMT may relate to improved PTSD symptoms; and that positive affect levels/dysregulation may be worthwhile targets for future ...