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Positive Processes and Transition to Health (PATH)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Jun 30, 2026 → Jul 31, 2027
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Record History

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  1. Primary and study completion pushed from Jun 30, 2026 to Jul 31, 2027v10
  2. Start date: Aug 22, 2024 to Sep 12, 2023v9
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2024 to Aug 22, 2024
    • Site details revised at 3 of 3 sites
    v8
  4. Start date: Jul 1, 2024 to Sep 1, 2024v7
  5. Start date: May 1, 2024 to Jul 1, 2024v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Feb 1, 2024 to May 1, 2024
    • Collaborators: 2 to 3
    v5
  2. Start date: Dec 1, 2023 to Feb 1, 2024v4
  3. Re-verified, no change to tracked fieldsv3
  4. Primary endpoints revised (3)
    • Secondary endpoints revised (3)
    • Study description expanded, about 3 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06093906
Lead Sponsor Case Western Reserve University
Collaborators: University of Washington, University of Delaware, National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Posttraumatic Stress Disorder, Major Depressive Disorder
Related terms Major Depressive Disorder, Stress Disorders, Post-Traumatic
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov