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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; PTSD
• Intervention / Treatment: Behavioral: PATH-SS

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Norah Feeny, PhD; Phone Number: (216) 368-2695; Email: ncf2@case.edu
• Study Contact Backup: Name: Jenna Bagley, MA; Phone Number: (216) 800-8492; Email: jmb534@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Western Reserve University
      • Contact: Norah C Feeny, PhD; Phone Number: 216-368-2695; Email: ncf2@case.edu
      • Principal Investigator: Norah C Feeny, PhD
      • Contact: Jenna M Bagley, MA; Phone Number: 216-800-8492; Email: jmb534@case.edu
      • Sub-Investigator: Jenna M Bagley, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PATH-SS; This single-session intervention includes the following components: Providing the PATH-SS rationale.; A review of life events (PATH of life: negative and positive).; A verbal narrative of the sexual assault (revisiting and processing as is done in imaginal exposure); Reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. In positive reminiscence, clients vividly remember the positive event providing details and focus on positive emotions. The therapist will encourage savoring of the experience and encourage facial expression of the positive emotions, so that clients do not dampen, avoid, or minimize the experience. This is particularly relevant with depression.; Summary of content, integration and consolidation of learning, application of new learning and resilience in real life as next steps.

Behavioral: PATH-SS; This single-session intervention includes the following components: Providing the PATH-SS rationale.; A review of life events (PATH of life: negative and positive).; A verbal narrative of the sexual assault (revisiting and processing as is done in imaginal exposure); Reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. In positive reminiscence, clients vividly remember the positive event providing details and focus on positive emotions. The therapist will encourage savoring of the experience and encourage facial expression of the positive emotions, so that clients do not dampen, avoid, or minimize the experience. This is particularly relevant with depression.; Summary of content, integration and consolidation of learning, application of new learning and resilience in real life as next steps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016)	The PSS-I is a 24-item, state-of-the-art, psychometrically-validated interview used to assess DSM-5 criteria for PTSD and symptom severity. The PSS-I-5 includes 20 questions assessing symptom severity on a 5-point Likert scale (0 = not at all, 4 = six or more times a week/severe), and scores are calculated by summing responses, with higher scores indicating higher PTSD severity, as well as two questions assessing distress and interference and two questions assessing symptom onset and duration.	From baseline to follow-up at 1 month after treatment completion
Quick Inventory of Depressive Symptomatology-Clinican Report (QIDS-C; Rush et al., 2003)	The QIDS-C is a 16 item, state-of-the-art, psychometrically-validated interview used to assess depression. Items are rated on a 4-point scale with anchors that vary with the question (e.g., 0 = I do not feel sad, 3 = I feel sad nearly all of the time).	From baseline to follow-up at 1 month after treatment completion
Post-traumatic Stress Diagnostic Scale (PDS-5; Foa et al., 2016)	The PDS-5 is a 24-item self-report measure used to assess prior trauma exposure and subsequent PTSD symptoms in the past month. The PDS-5 uses a trauma screen to identify prior exposure to traumatic events and assesses the severity of DSM-5 PTSD symptoms related to the event causing the most distress. The PDS-5 includes 20 questions assessing symptom severity on a 5-point Likert scale (0 = not at all, 4 = six or more times a week/severe), and scores are calculated by summing responses, with higher scores indicating higher PTSD severity. The PDS-5 also includes two questions assessing distress and interference and two questions assessing symptom onset and duration.	From baseline to follow-up at 1 month after treatment completion
Quick Inventory of Depressive Symptomatology Self-Report Version (QIDS-SR; Rush et al., 2003)	The QIDS-SR is a 16-item self-report measure that assesses depression. Items are rated on a 4-point scale with anchors that vary with the question (e.g., 0 = I do not feel sad, 3 = I feel sad nearly all of the time).	From baseline to follow-up at 1 month after treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995)	The SHAPS is a 14-item self-report measuring the capacity to experience pleasure. On a four-point scale (1 = Strongly Agree to 4 = Strongly Disagree), varying statements are rated (e.g., "I would find pleasure in small things"; "I would find pleasure in a telephone call from a friend"). The measure has good convergent and discriminant validity and reflects a unidimensional construct of anhedonia (Leventhal et al., 2006; Nakonezny et al., 2010).	From baseline to follow-up at 1 month after treatment completion
Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988)	The MSPSS is a 12-item self-report measure that assesses an individual's perceived level of social support from family, friends, and significant others. Items are rated on 7-point Likert scale (1 = Very Strongly Disagree, 7 = Very Strongly Agree).	From baseline to follow-up at 1 month after treatment completion
Working Alliance Inventory - Short Revised (WAI-SR; Munder et al., 2010)	The WAI-SR is a refined measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. The WAI-SR demonstrated good psychometric properties in an initial validation in psychotherapy outpatients in the USA (Munder et al., 2010), as well as in subsequent studies with college students (e.g., Jeong et al., 2023).	Post-treatment assessment and follow-up at 1 month after treatment completion
Relative Distress and Cost-Benefit Questions (Cromer et al., 2006; DePrince & Freyd, 2004)	Includes three questions measuring participants' experiences of relative distress and cost-benefit beliefs about the survey content: "Was completing study tasks related to the topic of unwanted sexual encounters more or less distressing than anticipated?"; "How important do you believe it is for psychologists to ask about unwanted sexual encounters in order to study the impact of them?"; and "Please consider both your experience completing study tasks related to the topic of unwanted sexual encounters, and your feelings about how important it is that we ask these questions. How good of an idea is it to include such tasks in psychology research?". Items are rated on a 5-point scale with anchors that vary with the question (e.g., 1 = much more distressing, 2 = somewhat more, 3= neutral, 4= somewhat less, and 5 = much less distressing).	Post-treatment assessment and follow-up at 1 month after treatment completion
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1994; 2004)	The CSQ-8 is an 8-item questionnaire used to assess satisfaction in mental health services (Sitzia, 1999). This tool includes a brief standardized scale with good psychometric properties that provides an overall assessment of satisfaction (Rush et al. 2008). An additional item was added to specifically assess single-session format of treatment.	Post-treatment assessment and follow-up at 1 month after treatment completion
Treatment Credibility Scale (CS, Addis & Carpenter, 1999)	The CS is a 6-item self-report questionnaire that was developed for the purpose of the present study to assess patients' perceptions of the credibility of the treatment they were being provided. Participants responded to each item by rat- ing the extent to which the treatment makes sense and is logical to them on a 5-point Likert-type scale ranging from 1 to 5. The six treatment credibility items are: (a) How credible do you think this therapy is? ("not at all credible" to "very credible"); (b) How logical does this therapy seem to you? ("not at all logical" to "very logical"); (c) How much do you trust this therapy to help you? ("not at all" to "very much"); (d) How credible does your therapist seem? ("not at all credible" to "very credible"); (e) How much do you trust your therapist to be able to help you? ("not at all" to "very much"); and (f) How knowledgeable does your therapist appear? ("not at all knowledgeable" to "very knowledgeable").	Post-treatment assessment and follow-up at 1 month after treatment completion
Utility of Techniques Inventory (UTI; adapted from Foa et al., 2002; Bluett et al., 2014)	This measure consists of 8 items assessing adherence to and utility of skills/techniques taught in therapy. Items are rated on a 5-point Likert scale with anchors that vary with the question (e.g., 0 = Not at all, 4 = More than 10 times; 0 = Not at all helpful, 4 = Extremely helpful).	Post-treatment assessment and follow-up at 1 month after treatment completion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment History Questionnaire (THQ)	This 4-item measure asks about current and past engagement in mental health services, respectively.	Baseline
Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998)	The MINI is a brief, structured diagnostic interview used to screen for the major psychiatric disorders according to current diagnostic standards (e.g., the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5]). Validation and reliability studies have been done comparing the MINI to the structured interviews developed by the American Psychiatric Assocaition and the World Health Organization (e.g., Amorim, 2000; Shields et al., 2021). The results of these studies show that the MINI has similarly high reliability and validity properties to both these instruments, but can be administered in a much shorter period of time (median administration time = 15 minutes).	Baseline
Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2008)	The C-SSRS will be administered by members of the study team (under the supervision of a licensed therapist) used to assess inclusion/exclusion criteria and monitor suicidality.	From baseline to follow-up at 1 month after treatment completion
Demographics Questionnaire	The demographics questionnaire asks participants to provide information related to their age, sex and gender identity, sexual orientation, ethnicity, relationship status, and college year, (if applicable).	Baseline

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: Norah C Feeny, PhD, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 22, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: trauma; depression; ptsd; posttraumatic stress; stressor
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Behavior; Depression; Wounds and Injuries; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: STUDY20240516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No