What this study is
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.
What's being tested
- Other
Intervention · BEHAVIORAL
Surveys will be distributed for data collection. A subset of patients will participate in diagnostic clinician interviews. No interventions will be tested.
Study details
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Adult Congenital Heart Disease · Congenital Heart Disease · PTSD
- Enrolling
- 1,000 people
- Starts
- 2025-09-01
- Est. completion
- 2026-08
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Congenital heart disease diagnosis, age >= 18 years
- Enrolled in CHI registry
- English proficiency for survey completion
- Access to an internet connection. Can be via computer or handheld device.
You can't join if
- Any who opt out
- Age < 18 years
- No diagnosis of congenital heart disease
- Not enrolled in CHI registry/unable to access Internet
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openChildren's National Medical Center
Washington D.C., District of Columbia, United States
- Anitha S John, M.D., Ph.D. · Contact202-476-2728anjohn@childrensnational.org
Not yet recruitingDartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
- David J Harrison, M.D. · Contact603-650-5724david.j.harrison@hitchcock.org
RecruitingNationwide Children's Hospital
Columbus, Ohio, United States
- Jamie Jackson, Ph.D. · Contact614-355-3426jamie.jackson2@nationwidechildrens.org
Not yet recruiting
Study team
Sponsor
Dartmouth-Hitchcock Medical Center
Study ID STUDY02002388
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.