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NCT06093906 · ClinicalTrials.gov registry record · NA
Positive Processes and Transition to Health (PATH)
A NA study of Major Depressive Disorder and Posttraumatic Stress Disorder, sponsored by Case Western Reserve University.
- Recruiting
- Registry status
- NA
- Development phase
- 135
- Enrollment target
- 3
- Study locations
NCT06093906 is a NA study of Major Depressive Disorder and Posttraumatic Stress Disorder that is actively recruiting participants, run by Case Western Reserve University. The registered enrollment target is 135 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (64% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06093906, a NA study of Major Depressive Disorder and Posttraumatic Stress Disorder, is actively recruiting participants, sponsored by Case Western Reserve University.
- RECRUITING
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Positive Processes and Transition to Health
- BEHAVIORAL Progressive Muscle Relaxation
Study Locations (3)
Delaware
- University of Delaware - Newark
Ohio
- Case Western Reserve University - Cleveland
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2023-09-12 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06093906
The ClinicalTrials.gov registry entry for NCT06093906 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (64% lower). The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Positive Processes and Transition to Health is the first listed.
NCT06093906 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Delaware, Ohio, Washington.
Frequently Asked Questions
What is clinical trial NCT06093906 about?
NCT06093906 is a clinical study titled "Positive Processes and Transition to Health (PATH)". 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 stres...
What is the current status of trial NCT06093906?
This trial is currently recruiting. It is a NA study. The enrollment target is 135 participants. The study started on 2023-09-12. Estimated completion is 2026-06-30.
What conditions does trial NCT06093906 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT06093906?
The interventions under investigation include: Positive Processes and Transition to Health (BEHAVIORAL), Progressive Muscle Relaxation (BEHAVIORAL).
Who is sponsoring clinical trial NCT06093906?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06093906 being conducted?
This trial has 3 study locations across Delaware, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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