NCT06093906 Positive Processes and Transition to Health (PATH)
| NCT ID | NCT06093906 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Western Reserve University |
| Condition | Posttraumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2023-09-12 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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). * Severe self-injurious behavior or suicide attempt within the previous three months. * Unwilling or unable to discontinue current cognitive behavioral psychotherapy. * No clear memory of the destabilizing event or event occurred before age 3. * Unstable dose of psychotropic medications in prior 3 months. * Ongoing intimate relationship with the perpetrator (in assault related event). * Current diagnosis of a substance use disorder (DSM-5).
Contact & Investigator
Norah Feeny, PhD
PRINCIPAL INVESTIGATOR
Case Western Reserve University
Frequently Asked Questions
Who can join the NCT06093906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Posttraumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06093906 currently recruiting?
Yes, NCT06093906 is actively recruiting participants. Contact the research team at ptsdlab@case.edu for enrollment information.
Where is the NCT06093906 trial being conducted?
This trial is being conducted at Newark, United States, Cleveland, United States, Seattle, United States.
Who is sponsoring the NCT06093906 clinical trial?
NCT06093906 is sponsored by Case Western Reserve University. The principal investigator is Norah Feeny, PhD at Case Western Reserve University. The trial plans to enroll 135 participants.