A program to improve mental health after traumatic events

Treatment of Stress-Related Psychopathology: Targeting Maladaptive and Adaptive Event Processing

This study is testing a new program called PATH to see if it helps people with PTSD and depression feel better after a traumatic event, compared to a relaxation technique called Progressive Muscle Relaxation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Case Western Reserve University (other)
• Locations: 3 sites (Newark, Delaware and 2 other locations)
• Trial ID: NCT06093906 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of the Positive Processes and Transition to Health (PATH) intervention compared to Progressive Muscle Relaxation (PMR) in individuals suffering from PTSD and major depressive disorder following a destabilizing life event. The study will involve 135 participants who will receive either PATH or PMR over six sessions, with follow-up assessments at multiple time points to measure changes in symptoms and therapeutic targets. The trial seeks to address common maladaptive processes that contribute to persistent mental health issues and aims to enhance resilience through targeted interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have experienced a significant life event within the last five years and exhibit symptoms of PTSD and/or depression.

Not a fit: Patients with severe mental health disorders such as schizophrenia, bipolar disorder, or those requiring immediate psychiatric intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for individuals struggling with PTSD and depression, potentially reducing symptoms and improving overall mental health.

How similar studies have performed: Previous studies have shown promise in addressing similar therapeutic targets in PTSD and depression, suggesting that this approach may yield beneficial results.

Eligibility criteria

Inclusion Criteria:

* Destabilizing life event involving profound loss or threat, with a minimum duration of 12 weeks since the event, but occurred within the last 5 years.
* Between the ages of 18 and 65.
* Elevated target: Scores of at least moderate (1 or higher) on at least 2 of the 3 target mechanisms: re- experiencing or ruminative processing of the destabilizing event (PSS-I items: 1, 2, 3, 4 or QIDS-C item 11), avoidance (PSS-I items 6, 7, 8), or reward deficits (PSS-I items 12, 13, or QIDS-C item 13).

Exclusion Criteria:

* 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.
* Unwilling or unable to discontinue current cognitive behavioral psychotherapy.
* No clear memory of the destabilizing event or event occurred before age 3.
* Unstable dose of psychotropic medications in prior 3 months.
* Ongoing intimate relationship with the perpetrator (in assault related event).
* Current diagnosis of a substance use disorder (DSM-5).

Where this trial is running

Newark, Delaware and 2 other locations

• University of Delaware — Newark, Delaware, United States (RECRUITING)
• Case Western Reserve University — Cleveland, Ohio, United States (RECRUITING)
• University of Washington — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Norah Feeny, PhD — Case Western Reserve University
• Study coordinator: Noni Shemenski, BA

Conditions: Posttraumatic Stress Disorder, Major Depressive Disorder