NCT06900712 Positive Processes and Transition to Health - Single-Session (PATH-SS)
| NCT ID | NCT06900712 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Western Reserve University |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2026-08-31 |
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 45 participants in total. It began in 2025-07-17 with a primary completion date of 2026-08-31.
⚠ 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 goal of this clinical trial is to test a brief, new psychotherapy (called Positive Processes and Transition to Health - Single Session, or PATH-SS) that aims to provide relief for people who are suffering after experiencing a sexual assault. This research will explore whether this new psychotherapy reduces sexual assault related distress, including posttraumatic stress and depression symptoms. The main questions it aims to answer are: Does PATH-SS leads to improvements in PTSD and depression symptoms (pre- to post- and 1-month follow-up)? Do participants perceive PATH-SS to be acceptable, helpful, and do they complete/adhere to treatment? Participants will complete a pre-treatment/baseline assessment to confirm eligibility, and those who are eligible will receive the single-session intervention and will complete a post-treatment and a 1-month follow-up assessment of stressor-related symptoms.
Eligibility Criteria
Inclusion Criteria: 1. Age range: from 18 to 65. 2. Has experienced unwanted sexual contact or sexual assault with a minimum of 12 weeks since the event and a maximum of 5 years since the event. 3. Residence in the state of Ohio. 4. Elevated symptoms on either the Posttraumatic Diagnostic Scale (PDS-5) or the Quick Inventory of Depressive Symptomatology (QIDS-SR), at least moderate: 18 on PDS-5 (Foa et al., 2016) and/or 11 on QIDS (moderate depression severity; Rush et al., 2003), with symptoms persisting for 1 month or longer. Exclusion Criteria: 1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5. 2. 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). 3. Severe self-injurious behavior or suicide attempt within the previous three months. 4. Currently engaged in cognitive behavioral psychotherapy. 5. No clear memory of the event. 6. Unstable dose of psychotropic medications in prior 3 months. 7. Ongoing intimate relationship with the perpetrator. 8. Current diagnosis of a substance use disorder (DSM-5). 9. Residence outside the state of Ohio.
Contact & Investigator
Norah C Feeny, PhD
PRINCIPAL INVESTIGATOR
Case Western Reserve University
Frequently Asked Questions
Who can join the NCT06900712 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06900712 currently recruiting?
Yes, NCT06900712 is actively recruiting participants. Contact the research team at ncf2@case.edu for enrollment information.
Where is the NCT06900712 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06900712 clinical trial?
NCT06900712 is sponsored by Case Western Reserve University. The principal investigator is Norah C Feeny, PhD at Case Western Reserve University. The trial plans to enroll 45 participants.
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