RecruitingNot ApplicableNCT06093906

Positive Processes and Transition to Health (PATH)

Treatment of Stress-Related Psychopathology: Targeting Maladaptive and Adaptive Event Processing


Sponsor

Case Western Reserve University

Enrollment

135 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The R33 will be a randomized controlled trial to replicate changes in the targets (unproductive processing, avoidance, reward deficits) from the R61 phase in a larger sample of 135 participants who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, this study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle Relaxation (PMR). In the R33 phase, the investigators will examine changes in target mechanisms predicting improvements in PTSD and depressive symptoms, as well as feasibility and acceptability. Patients will receive 6 sessions of PATH or PMR (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 3, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

The PATH study is a mental health program designed for adults who have gone through a major life disruption — such as a bereavement, serious illness diagnosis, relationship loss, or job loss. It tests a new treatment approach to help people recover from the emotional impact of such events and build positive coping skills. **You may be eligible if...** - You are between 18 and 65 years old - You experienced a significant, destabilizing life event in the past 5 years (at least 12 weeks ago) - You are experiencing ongoing symptoms such as intrusive thoughts, avoidance, or loss of pleasure in things you used to enjoy **You may NOT be eligible if...** - You have a current diagnosis of schizophrenia, delusional disorder, or severe organic mental illness - You have bipolar disorder, psychotic depression, or depression severe enough to need immediate psychiatric treatment - You require urgent mental health intervention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPositive Processes and Transition to Health

See arm/group description for details regarding this intervention

BEHAVIORALProgressive Muscle Relaxation

See arm/group description for details regarding this intervention


Locations(3)

University of Delaware

Newark, Delaware, United States

Case Western Reserve University

Cleveland, Ohio, United States

University of Washington

Seattle, Washington, United States

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NCT06093906


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