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

NCT06900712 | Recruiting DMC

• 1 other identifier: STUDY20240516
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Depression

Keywords

ptsd; trauma; depression; stressor; posttraumatic stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995)

  From baseline to follow-up at 1 month after treatment completion

• Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988)

  From baseline to follow-up at 1 month after treatment completion

• Working Alliance Inventory - Short Revised (WAI-SR; Munder et al., 2010)

  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)

  Post-treatment assessment and follow-up at 1 month after treatment completion

• Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1994; 2004)

  Post-treatment assessment and follow-up at 1 month after treatment completion

Other Outcomes (4)

• Demographics Questionnaire

  Baseline

• Treatment History Questionnaire (THQ)

  Baseline

• Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998)

  Baseline

Study Arms (1)

PATH-SS

EXPERIMENTAL

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

Interventions

PATH-SS BEHAVIORAL

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.

PATH-SS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5.
• 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).
• Residence outside the state of Ohio.

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Norah C Feeny, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norah Feeny, PhD

CONTACT

(216) 368-2695; ncf2@case.edu

Jenna Bagley, MA

CONTACT

(216) 800-8492; jmb534@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 28, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)