Positive Processes and Transition to Health (PATH)
Launched by CASE WESTERN RESERVE UNIVERSITY · Oct 17, 2023
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
The PATH trial is researching how different therapies can help people who have experienced a traumatic event and are dealing with symptoms of Posttraumatic Stress Disorder (PTSD) or Major Depressive Disorder. The study will involve 135 participants who have faced significant life challenges, such as loss or threat, and are showing signs of distress related to their experiences. Participants will be randomly assigned to receive either the PATH therapy, which focuses on positive mental processes, or Progressive Muscle Relaxation (PMR), which is a technique to reduce stress and tension. Over six sessions, and possibly two additional ones if needed, the study aims to see how these therapies can improve symptoms of PTSD and depression, while also measuring how participants feel about the treatments.
To participate, individuals must be between 18 and 65 years old and have experienced a traumatic event within the last five years that has significantly affected their mental health. They should also be showing moderate to severe symptoms related to their experiences. However, certain conditions, like severe mental health disorders or substance abuse issues, would prevent someone from joining the study. Participants will be assessed at the beginning of the trial, during treatment, and after treatment to track their progress and the effectiveness of the therapies. This trial is currently recruiting participants, and it’s a great opportunity for those looking for support in managing their mental health after a tough experience.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- • Elevated target: Scores of at least moderate (1 or higher) on at least 2 of the 3 target mechanisms: re- experiencing or ruminative processing of the destabilizing event (PSS-I items: 1, 2, 3, 4 or QIDS-C item 11), avoidance (PSS-I items 6, 7, 8), or reward deficits (PSS-I items 12, 13, or QIDS-C item 13).
- Exclusion Criteria:
- • Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5.
- • 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.
- • Unwilling or unable to discontinue current cognitive behavioral psychotherapy.
- • No clear memory of the destabilizing event or event occurred before age 3.
- • Unstable dose of psychotropic medications in prior 3 months.
- • Ongoing intimate relationship with the perpetrator (in assault related event).
- • Current diagnosis of a substance use disorder (DSM-5).
About Case Western Reserve University
Case Western Reserve University (CWRU) is a leading research institution located in Cleveland, Ohio, renowned for its commitment to advancing knowledge and improving health outcomes through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, CWRU integrates expertise from various fields, including medicine, engineering, and social sciences, to address complex health challenges. The university's clinical trial initiatives are designed to foster the development of novel therapies and interventions, ensuring rigorous scientific methodologies and ethical standards are upheld. CWRU is dedicated to translating research findings into tangible benefits for patients and communities, contributing significantly to the advancement of healthcare practices and policies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
Cleveland, Ohio, United States
Newark, Delaware, United States
Patients applied
Trial Officials
Norah Feeny, PhD
Principal Investigator
Case Western Reserve University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported