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

NCT ID: NCT06900712

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-17
• Study Completion Date: 2026-05-31

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.

Conditions

PTSD; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PATH-SS

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Norah Feeny

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norah C Feeny, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Case Western Reserve University

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Norah Feeny, PhD

Role: CONTACT

ncf2@case.edu

(216) 368-2695

Jenna Bagley, MA

Role: CONTACT

jmb534@case.edu

(216) 800-8492

Facility Contacts

Norah C Feeny, PhD

Role: primary

ncf2@case.edu

216-368-2695

Jenna M Bagley, MA

Role: backup

jmb534@case.edu

216-800-8492

Other Identifiers

STUDY20240516

Identifier Type: -

Identifier Source: org_study_id