NCT06093906Recruiting
Positive Processes and Transition to Health (PATH)
Treatment of Stress-Related Psychopathology: Targeting Maladaptive and Adaptive Event Processing
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- First submitted
- 17 Oct 2023
- Start date
- 12 Sept 2023
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Case Western Reserve University
- Diseases
- Depression
- NCT number
- NCT06093906
What you commit to
- Study type: Interventional
- Planned participants: 135
- From 12 Sept 2023 to the primary completion date, 31 Jul 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe self-injurious behavior or suicide attempt within the previous three months.
- Unstable dose of psychotropic medications in prior 3 months.
Other illness
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5.
- Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
- Current diagnosis of a substance use disorder (DSM-5).
Age
- No clear memory of the destabilizing event or event occurred before age 3.
Other
- Unwilling or unable to discontinue current cognitive behavioral psychotherapy.
- Ongoing intimate relationship with the perpetrator (in assault related event).
Who the study is looking for
- Destabilizing life event involving profound loss or threat, with a minimum duration of 12 weeks since the event, but occurred within the last 5 years.
- Between the ages of 18 and 65.
- Elevated target: Scores of at least moderate (1 or higher) on at least 2 of the 3 target mechanisms: re- experiencing or ruminative processing of the destabilizing event (PSS-I items: 1, 2, 3, 4 or QIDS-C item 11), avoidance (PSS-I items 6, 7, 8), or reward deficits (PSS-I items 12, 13, or QIDS-C item 13).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| University of Delaware Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.