RECRUITING

Positive Processes and Transition to Health - Single-Session (PATH-SS)

Conditions

PTSD Depression trauma stressor posttraumatic stress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Novel, Single-Session Intervention for Sexual Assault-Related Psychopathology Among College Students

Quick Facts

Study Start:2025-03

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06900712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age range: from 18 to 65. 2. Has experienced unwanted sexual contact or sexual assault during their time as a college student, with a minimum of 12 weeks since the event and a maximum of 5 years since the event. 3. Enrolled in any undergraduate, graduate, or professional program at a college or university 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.	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.

Inclusion Criteria

Exclusion Criteria

1. Age range: from 18 to 65.
2. Has experienced unwanted sexual contact or sexual assault during their time as a college student, with a minimum of 12 weeks since the event and a maximum of 5 years since the event.
3. Enrolled in any undergraduate, graduate, or professional program at a college or university 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.

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.

Contacts and Locations

Study Contact

Norah Feeny, PhD

CONTACT

(216) 368-2695

ncf2@case.edu

Jenna Bagley, MA

CONTACT

(216) 800-8492

jmb534@case.edu

Principal Investigator

Norah C Feeny, PhD

PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Study Locations (Sites)

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Case Western Reserve University

Norah C Feeny, PhD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2025-03

Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

ptsd
trauma
depression
stressor
posttraumatic stress

Additional Relevant MeSH Terms

PTSD
Depression