RecruitingRecruiting
Positive Processes and Transition to Health - Single-Session (PATH-SS)
NCT06900712 · Case Western Reserve University
In plain English
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Official title
A Novel, Single-Session Intervention for Sexual Assault-Related Psychopathology
About this study
This study will be an open trial to determine if PATH-SS reduces stressor-related symptoms of PTSD and/or depression after sexual assault in a sample of 45 adults who have experienced a sexual assault. Potential participants will first undergo a pre-screening to assess for likelihood of eligibility. Participants who may be eligible will proceed to the pre-treatment/baseline assessment; those excluded will be given referrals.
After informed consent is obtained, participants will complete the pre-treatment/baseline assessment to confirm eligibility. The assessing clinician will consult with the PI before making eligibility decisions. Eligible participants will then receive one session of the PATH-SS intervention, lasting up to 2 hours.
Symptoms will be assessed pre-treatment, post-treatment, and at 1-month follow-up, with each assessment lasting approximately 1 hour. Participants will be compensated $20 via Amazon or Visa gift card for each assessment completed following treatment. Participants will not be compensated for the intervention session.
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.
Study design
Enrollment target: 45 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-17
Estimated completion: 2027-05-31
Last updated: 2026-04-22
Interventions
Behavioral: PATH-SS
Primary outcomes
- • PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016) (From baseline to follow-up at 1 month after treatment completion)
- • Quick Inventory of Depressive Symptomatology-Clinican Report (QIDS-C; Rush et al., 2003) (From baseline to follow-up at 1 month after treatment completion)
- • Post-traumatic Stress Diagnostic Scale (PDS-5; Foa et al., 2016) (From baseline to follow-up at 1 month after treatment completion)
Sponsor
Case Western Reserve University · other
Contacts & investigators
ContactNorah Feeny, PhD · contact · ncf2@case.edu · (216) 368-2695
ContactJenna Bagley, MA · contact · jmb534@case.edu · (216) 800-8492
InvestigatorNorah C Feeny, PhD · principal_investigator, Case Western Reserve University
All locations (1)
Case Western Reserve UniversityRecruiting
Cleveland, Ohio, United States