Recruiting

PATH-SS

Sponsor:

Case Western Reserve University

Code:

NCT06900712

Conditions

PTSD

Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

PATH-SS

Study Details

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

Study ID

NCT06900712

Start date

Jul 17, 2025

Status verified date

Apr, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016) [ Time Frame: From baseline to follow-up at 1 month after treatment completion ]
  • Quick Inventory of Depressive Symptomatology-Clinican Report (QIDS-C; Rush et al., 2003) [ Time Frame: From baseline to follow-up at 1 month after treatment completion ]
  • Post-traumatic Stress Diagnostic Scale (PDS-5; Foa et al., 2016) [ Time Frame: 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) [ Time Frame: From baseline to follow-up at 1 month after treatment completion ]

Central Contacts and Locations

Central contacts

Norah Feeny, PhD

(216) 368-2695ncf2@case.edu

Jenna Bagley, MA

(216) 800-8492jmb534@case.edu

Locations

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Norah C Feeny, PhD

216-368-2695ncf2@case.edu

Jenna M Bagley, MA

216-800-8492jmb534@case.edu

Principal Investigator:

Norah C Feeny, PhD

More Information

Sponsor

Case Western Reserve University

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • ptsd
  • trauma
  • depression
  • stressor
  • posttraumatic stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-04-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.