NCT06952933

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Sep 2025Aug 2026

First Submitted

Initial submission to the registry

January 8, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 25, 2026

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

January 8, 2025

Last Update Submit

March 23, 2026

Conditions

Congenital Heart DiseasePTSDAdult Congenital Heart Disease

Keywords

adult congenital heart diseaseachdcongenital heart diseasepediatric cardiologyptsdpost-traumatic stress disorderresilience

Outcome Measures

Primary Outcomes (1)

  • PTSD checklist for DSM-5 (PCL-5)

    A 20-item survey of the five domains of PTSD as described by the DSM-5. Each item is on a five-point Likert scale describing severity of symptoms (bothered by symptoms "not at all" to "extremely"). Each item is graded 0 to 4, for a total PCL-5 score ranging from 0 to 80. Historical studies have recommended a cutoff for PTSD-positive around 31 to 33. This study will attempt to validate the proper cutoff in the ACHD population using the diagnostic interview.

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

Secondary Outcomes (2)

  • Clinician Administered PTSD Scale Diagnostic Interview (CAPS-5)

    One-time interview during study months 4 to 12

  • Connor-Davidson Resilience Scale (CD-RISC)

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

Study Arms (1)

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

Interventions

OtherBEHAVIORAL

Surveys will be distributed for data collection. A subset of patients will participate in diagnostic clinician interviews. No interventions will be tested.

Also known as: Assessment of PTSD symptoms and resilience
Overall cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any adult with a congenital heart disease diagnosis

You 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 may not qualify if:

  • Any who opt out
  • Age \< 18 years
  • No diagnosis of congenital heart disease
  • Not enrolled in CHI registry/unable to access Internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

NOT YET RECRUITING

Related Publications (4)

  • Webb G, Landzberg MJ, Daniels CJ. Specialized adult congenital heart care saves lives. Circulation. 2014 May 6;129(18):1795-6. doi: 10.1161/CIRCULATIONAHA.114.009049. Epub 2014 Mar 3. No abstract available.

    PMID: 24589850BACKGROUND

  • Steiner JM, Nassans K, Brumback L, Stout KK, Longenecker CT, Yi-Frazier JP, Curtis JR, Rosenberg AR. Key Psychosocial Health Outcomes and Association With Resilience Among Patients With Adult Congenital Heart Disease. JACC Adv. 2024 May;3(5):100917. doi: 10.1016/j.jacadv.2024.100917. Epub 2024 Mar 28.

    PMID: 38846320BACKGROUND

  • Phillippi R, Leezer S, Messmer M, Hile D, John AS. Patient Engagement in Research: Considerations in Creating a Registry for Adults with Congenital Heart Disease. Curr Cardiol Rep. 2024 Jan;26(1):15-21. doi: 10.1007/s11886-023-02013-2. Epub 2023 Dec 22.

    PMID: 38133788BACKGROUND

  • Harrison DJ, Kay J, Jacobsen RM, Londono-Obregon C, Yeung E, Kelly SL, Poteet A, Levek C, Landzberg MJ, Wallrich M, Khanna A. The burden of psychological trauma and post-traumatic stress disorder among adults with congenital heart disease: PTSD in ACHD. Am J Cardiol. 2024 May 15;219:9-16. doi: 10.1016/j.amjcard.2024.03.007. Epub 2024 Mar 6.

    PMID: 38458583BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Defects, CongenitalStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

David J Harrison, MD

CONTACT

603-650-5724david.j.harrison@hitchcock.org

Jamie Jackson, PhD

CONTACT

jamie.jackson2@nationwidechildrens.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 8, 2025

First Posted

May 1, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 25, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

This study is not a clinical trial and does not have an intervention group. Some data collected will be on sensitive topics. No current plan to share data with other researchers.

Locations

US(3)