PTSD in ACHDNCT06952933

Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease

StatusRecruiting

PhaseNot specified

SponsorDartmouth-Hitchcock Medical Center

Primary completionJun 2027 (estimated)

At risk: Primary completion moved at least 11 months later.

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 12, 2026 Primary completion pushed from Jun 2026 to Jun 2027 Show 6 more changesShow less
- Eligibility criteria expanded, about 8 words
- Study completion pushed from Aug 2026 to Aug 2027
- Secondary endpoints: details revised at 2 of 2 entries
- Study description revised
- Site details revised at 2 of 3 sites
- Publications: details revised at 4 of 4 entries
Notable Mar 23, 2026 Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
- Primary completion date: Dec 2025 to Jun 2026
- Study completion date: Jun 2026 to Aug 2026
- Start date changed from estimate of Jul 2025 to Sep 1, 2025
- Site details revised at 3 of 3 sites
Notable Jun 24, 2025 Start date: May 2025 to Jul 2025
- Primary completion date: Aug 2025 to Dec 2025
- Study completion date: Feb 2026 to Jun 2026
v2
Apr 28, 2025 Study First Submitted

Notable: the plan changed

Endpoints

Primary

PTSD checklist for DSM-5 (PCL-5)

Timeframe: One-time survey. Distribute to patients during months ~1-2.

Secondary (2)

Clinician Administered PTSD Scale Diagnostic Interview (CAPS-5)

Connor-Davidson Resilience Scale (CD-RISC)

Arms and interventions

Overall cohort

Adults 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.

Behavioral: Other

Sites

3 sites in 1 country

About this trial

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.

Trial details

Enrollment: 1,000 participants (estimated)
Started: Sep 1, 2025
Study completion: Aug 2027 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Heart Defects, Congenital, Stress Disorders, Post-Traumatic, Adult Congenital Heart Disease, Congenital Heart Disease, PTSD
Collaborators: Adult Congenital Heart Association
First posted: May 1, 2025
Registry updated: Nov 13, 2026
Last verified: Jun 2026

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