Clinical trial NCT06900712: Positive Processes and Transition to Health - Single-Session (PATH-SS)
Official title: A Novel, Single-Session Intervention for Sexual Assault-Related Psychopathology Among College Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Depression
Keywords: ptsd
trauma
depression
stressor
posttraumatic stress
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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 college students who have experienced a sexual assault. Potential participants will first undergo a pre-screening to assess for likelihood of elegibility. 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 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 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.

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.

Primary outcomes:
measure: PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016)
timeFrame: From baseline to follow-up at 1 month after treatment completion
measure: 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
measure: Post-traumatic Stress Diagnostic Scale (PDS-5; Foa et al., 2016)
timeFrame: From baseline to follow-up at 1 month after treatment completion
measure: 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
Secondary outcomes:
measure: Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995)
timeFrame: From baseline to follow-up at 1 month after treatment completion
measure: Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988)
timeFrame: From baseline to follow-up at 1 month after treatment completion
measure: Working Alliance Inventory - Short Revised (WAI-SR; Munder et al., 2010)
timeFrame: Post-treatment assessment and follow-up at 1 month after treatment completion
measure: Relative Distress and Cost-Benefit Questions (Cromer et al., 2006; DePrince & Freyd, 2004)
timeFrame: Post-treatment assessment and follow-up at 1 month after treatment completion
measure: Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1994; 2004)
timeFrame: Post-treatment assessment and follow-up at 1 month after treatment completion
measure: Treatment Credibility Scale (CS, Addis & Carpenter, 1999)
timeFrame: Post-treatment assessment and follow-up at 1 month after treatment completion
measure: Utility of Techniques Inventory (UTI; adapted from Foa et al., 2002; Bluett et al., 2014)
timeFrame: Post-treatment assessment and follow-up at 1 month after treatment completion
Other outcomes:
measure: Demographics Questionnaire
timeFrame: Baseline
measure: Treatment History Questionnaire (THQ)
timeFrame: Baseline
measure: Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998)
timeFrame: Baseline
measure: Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2008)
timeFrame: From baseline to follow-up at 1 month after treatment completion
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Norah C Feeny, PhD
role: PRINCIPAL_INVESTIGATOR
References: