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RECRUITING
NCT06093906
NA

Positive Processes and Transition to Health (PATH)

Sponsor: Case Western Reserve University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2023-09-12

Completion Date

2026-06-30

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

BEHAVIORAL

Positive Processes and Transition to Health

See arm/group description for details regarding this intervention

BEHAVIORAL

Progressive 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