Positive Processes and Transition to Health - Single-Session (PATH-SS) (NCT06900712) | Clinical Trial Compass
RecruitingNot Applicable
Positive Processes and Transition to Health - Single-Session (PATH-SS)
United States45 participantsStarted 2025-07-17
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age range: from 18 to 65.
. 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.
. Residence in the state of Ohio.
. 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
. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016)
Timeframe: From baseline to follow-up at 1 month after treatment completion
2
Quick Inventory of Depressive Symptomatology-Clinican Report (QIDS-C; Rush et al., 2003)
Timeframe: From baseline to follow-up at 1 month after treatment completion
3
Post-traumatic Stress Diagnostic Scale (PDS-5; Foa et al., 2016)
Timeframe: From baseline to follow-up at 1 month after treatment completion
4
Quick Inventory of Depressive Symptomatology Self-Report Version (QIDS-SR; Rush et al., 2003)
Timeframe: From baseline to follow-up at 1 month after treatment completion
. 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.
. Currently engaged in cognitive behavioral psychotherapy.
. No clear memory of the event.
. Unstable dose of psychotropic medications in prior 3 months.
. Ongoing intimate relationship with the perpetrator.
. Current diagnosis of a substance use disorder (DSM-5).