A program to improve mental health after traumatic events

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ptsdlab@case.edu
• Phone: 216-368-0338

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating risk and resilience factors in RCMP members

  This study is testing how different factors affect the mental health of new RCMP cadets, especially regarding posttraumatic stress, and whether training in emotional resilience can help them cope better.

  Recruiting University of Regina · Regina, Saskatchewan · NCT05527509

• Dupilumab for Major Depressive Disorder

  This study tests whether dupilumab can engage immune targets in adults with major depressive disorder to see if it can help with depressive symptoms.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07908563

• Reboxetine plus Ritalin vs Dog-Assisted Therapy for PTSD

  This study tests whether a drug combo of reboxetine and methylphenidate works better than dog-assisted therapy for people with PTSD.

  Recruiting Phase 2 University of Haifa · Haifa · NCT07771530

• Accelerated vs Standard iTBS for Major Depression

  This trial tests whether giving more accelerated iTBS sessions is better tolerated and more effective than the standard schedule for adults with major depressive disorder.

  Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07768397

• Psilocybin with Structured Integrated Reframing Therapy for trauma-related MDD and PTSD

  This trial tests whether psilocybin therapy, alone or with Structured Integrated Reframing Therapy (SIRT), helps people with trauma-related major depressive disorder who are already on a stable antidepressant.

  Recruiting Phase 3 Khyber Medical University Peshawar · Islamabad, Capital and 2 other locations · NCT07703722

• Magnesium Bisglycinate Added to Your Depression Treatment

  This study tests whether adding magnesium bisglycinate to your current antidepressant can help reduce depressive symptoms and improve sleep and daily functioning for adults with major depressive disorder.

  Recruiting All India Institute of Medical Sciences, Bhubaneswar · Bhubaneswar, Odisha · NCT07633080

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.