Actively Recruiting
Positive Processes and Transition to Health (PATH)
Led by Case Western Reserve University · Updated on 2025-07-30
135
Participants Needed
3
Research Sites
146 weeks
Total Duration
On this page
Sponsors
C
Case Western Reserve University
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Positive Processes and Transition to Health (PATH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Experienced a destabilizing life event with profound loss or threat between 12 weeks and 5 years ago
- Aged between 18 and 65 years
- Elevated symptoms on at least two of three targets: unproductive event processing, avoidance, or reward deficits
You will not qualify if you...
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder
- Current diagnosis of bipolar disorder, depression with psychotic features, or severe depression needing immediate psychiatric treatment
- Severe self-injury or suicide attempt in the past three months
- Unable or unwilling to stop current cognitive behavioral psychotherapy
- No clear memory of the destabilizing event or event happened before age 3
- Unstable psychotropic medication dose in the past three months
- Ongoing intimate relationship with the perpetrator if the event was assault-related
- Current diagnosis of a substance use disorder
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Delaware
Newark, Delaware, United States, 19716
Actively Recruiting
2
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
3
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
N
Noni Shemenski, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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