Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Study ID
- NCT06952933
- Status
- Recruiting
Conditions
- Adult Congenital Heart Disease
- Congenital Heart Disease
- PTSD
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Other — BEHAVIORALSurveys will be distributed for data collection. A subset of patients will participate in diagnostic clinician interviews. No interventions will be tested.
Study Details
The purpose of this study, entitled "Psychological trauma, post-traumatic stress disorder, and resilience in adults with congenital heart disease in a large population sample", is to evaluate for exposures during a lifetime with congenital heart disease that may be associated with higher likelihood of developing PTSD. Primary aim: \- Identify individual patient characteristics (medical, psychosocial, socioeconomic, etc.) that are associated with a diagnosis of PTSD. Secondary aims: * Calculate the prevalence of those meeting PTSD criteria in the ACHD population using the "gold standard" diagnostic clinician interview, while using the same data to validate a PTSD screening self-report survey in the ACHD population. * Determine the role of resilience in ACHD patients using a validated screening survey to assess its protective role toward PTSD. Hypotheses: * There are certain exposures (e.g. post-surgical pain, ICU delirium, bullying due to CHD) that are associated with a higher incidence and odds of meeting PTSD criteria. * "Gold standard" diagnostic interviews will most accurately estimate the prevalence of PTSD in ACHD which has been overestimated on prior screening-based studies, although the scope of the problem is still great. * Patients with a higher resilience score will show an association with a lower risk of PTSD.
Key Dates
- Start date
- Sep 1, 2025
- Status verified
- Jun 2025
- Primary completion
- Jun 30, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Overall cohortAdults age \>= 18-years with a diagnosis of congenital heart disease. Congenital heart disease will be defined by previously published classification including those listed in the American Heart Association/ American College of Cardiology guidelines for the care of adults with congenital heart disease.
Primary Outcome Measure
PTSD checklist for DSM-5 (PCL-5) [ Time Frame: One-time survey. Distribute to patients during months ~1-2. ]
Central Contacts
- David J Harrison, MD603-650-5724
- Jamie Jackson, PhD
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 |
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