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

March 23, 2026 updated by: David J. Harrison, Dartmouth-Hitchcock Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

This study will use the existing registry for the Congenital Heart Initiative (CHI), which contains over 4,000 ACHD patients who have opted in to receive surveys from this research team. The CHI was launched in late 2020, and full information can be found at [clinicaltrials.gov ID: NCT05185232]. For this PTSD and resilience arm of the study, an email invitation will be sent to all CHI members, who can opt in to complete surveys assessing psychological trauma as a consequence of one's heart disease.

The first stage will be a distribution of approximately two surveys. The first survey is called the Post-traumatic Stress Disorder Checklist for the DSM-5 (PCL-5), a 20-item screening tool with a score ranging from 0 (no symptoms) to 80 (highest symptoms). As a screener, this survey does not diagnose PTSD, but identifies those who are experiencing significant symptoms. Because of the sensitive nature of this topic, all survey items are optional and there is no penalty for not finishing the survey.

The next survey will study resilience, most likely using the Connor-Davidson Resilience Scale, which has been tested in other ACHD studies. Resilience is defined as a person's ability to withstand and recover from stressful life experiences. Studying resilience will serve as an ideal balancing measure to the study of PTSD.

The final stage of this study will be in-person diagnostic interviews. Trained psychology research assistants will help administer the Clinician Administered PTSD Diagnostic Interview (CAPS-5) via video conference. Recruitment for this phase will include a subset of respondents who are invited from those who completed the PCL-5 to participate in the CAPS-5 if they choose to do so. This will include all ranges of scores on the PCL-5, representing those who screen positive and negative using the PCL-5. The CAPS-5 is considered the gold standard for PTSD diagnosis, and can provide valuable validation information for the PCL-5 in this population. At the conclusion of the interview, the study team may discuss resilience-building strategies as a qualitative assessment.

Overall, the investigators aim to estimate the prevalence of psychological trauma and PTSD in the ACHD population, as well as learning strategies to build resilience. This study will also aim to validate the screening tools for PTSD and resilience, so they may be implemented in the outpatient setting. The study team will assess for conditions that are most associated with PTSD and resilience, to help identify patients who may be at higher risk based on their illness course. Stressful experiences such as surgeries, arrhythmias, ICU admissions, and general anxiety about one's heart may be unavoidable at times. By understanding what drives a patient's illness experience, clinicians can plan for interventions to reduce trauma and build resilience.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Not yet recruiting
        • Children's National Medical Center
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • Ohio
      • Columbus, Ohio, United States, 43205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any adult with a congenital heart disease diagnosis

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Surveys will be distributed for data collection. A subset of patients will participate in diagnostic clinician interviews. No interventions will be tested.
Other Names:
  • Assessment of PTSD symptoms and resilience

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD checklist for DSM-5 (PCL-5)
Time Frame: One-time survey. Distribute to patients during months ~1-2.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale Diagnostic Interview (CAPS-5)
Time Frame: One-time interview during study months 4 to 12
For a subset of patients: The CAPS-5 scoring system ranges from 0 to 80, with measures for symptom severity and frequency for each of the PTSD symptom clusters as defined by the DSM-5. Questioning and scoring will be performed by trained facilitators who will conduct the diagnostic interview via video conference. A higher score indicates more severe symptoms, while the presence of symptoms for each symptom cluster is required to confirm a diagnosis of PTSD.
One-time interview during study months 4 to 12
Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: One-time survey. Distribute to patients during months ~1-2.
A 10-item survey of statements that are associated with resilience. Respondents will indicate their level of agreement on a 5-point Likert scale (range 0 to 4), for a total score of 0 to 40. A higher score indicates a higher level of resilience.
One-time survey. Distribute to patients during months ~1-2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Adult Congenital Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02002388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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