New psychotherapy for PTSD and depression after sexual assault

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

This study is testing a new short therapy session to see if it can help college students who have experienced sexual assault feel better by reducing their PTSD and depression symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Case Western Reserve University (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06900712 on ClinicalTrials.gov

What this trial studies

This clinical trial tests a brief psychotherapy called Positive Processes and Transition to Health - Single Session (PATH-SS) aimed at alleviating distress related to sexual assault, specifically targeting PTSD and depression symptoms. The study involves a sample of 45 college students who have experienced sexual assault, assessing their symptoms before and after a single 2-hour session of PATH-SS, as well as at a 1-month follow-up. Participants will undergo a pre-treatment assessment to confirm eligibility and will be compensated for their participation in assessments.

Who should consider this trial

Good fit: Ideal candidates are college students aged 18 to 65 who have experienced sexual assault within the last 5 years and exhibit moderate to severe PTSD or depression symptoms.

Not a fit: Patients with severe mental health disorders such as schizophrenia or bipolar disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide significant relief for individuals suffering from PTSD and depression following sexual assault.

How similar studies have performed: While this approach is innovative, similar interventions targeting PTSD and depression have shown promise in other studies.

Eligibility criteria

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.

Where this trial is running

Cleveland, Ohio

• Case Western Reserve University — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Norah C Feeny, PhD — Case Western Reserve University
• Study coordinator: Norah Feeny, PhD

Conditions: PTSD, Depression, ptsd, trauma, depression, stressor, posttraumatic stress