Adult Congenital Heart DiseasePTSD in ACHDNCT06952933
Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease
An observational study of Adult Congenital Heart Disease and Congenital Heart Disease, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Congenital Heart Disease, Congenital Heart Disease, PTSD
- What is being tested?
- Other
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2025to Aug 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult with a congenital heart disease diagnosis
Who may be able to join
- 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.
Who cannot join
- Any who opt out
- Age < 18 years
- No diagnosis of congenital heart disease
- Not enrolled in CHI registry/unable to access Internet
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jamie Jackson, PhD contact
United States3 sites, 3 recruiting
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Jamie Jackson, Ph.D., 614-355-3426, jamie.jackson2@nationwidechildrens.org
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
David J Harrison, M.D., 603-650-5724, david.j.harrison@hitchcock.org
- Not yet recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Anitha S John, M.D., Ph.D., 202-476-2728, anjohn@childrensnational.org
About this study
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:
Read more
- 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.
Read the 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.
- Being tested
- Other
- Keywords
- adult congenital heart disease, achd, congenital heart disease, pediatric cardiology, ptsd, post-traumatic stress disorder, resilience
- Medical subject headings
- Heart Defects, Congenital, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherBehavioural
Also called Assessment of PTSD symptoms and resilience
Surveys will be distributed for data collection. A subset of patients will participate in diagnostic clinician interviews. No interventions will be tested.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One-time survey. Distribute to patients during months ~1-2.
Secondary outcomes (2)
Clinician Administered PTSD Scale Diagnostic Interview (CAPS-5)
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.
Measured: One-time interview during study months 4 to 12
Connor-Davidson Resilience Scale (CD-RISC)
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.
Measured: One-time survey. Distribute to patients during months ~1-2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adult Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Adult Congenital Heart Association
- Responsible party
- Principal investigator, David J. Harrison, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952933
- Sponsor's protocol ID
- STUDY02002388
- Acronym
- PTSD in ACHD
- Status last verified
- Jun 2025
- First submitted
- 8 Jan 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 24589850Steiner 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.
PubMed 38846320Phillippi 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.
PubMed 38133788Harrison 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.
PubMed 38458583
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06952933
- Acronym / sponsor ID
- PTSD in ACHD / STUDY02002388
- Keywords
- adult congenital heart disease, achd, congenital heart disease, pediatric cardiology, ptsd, post-traumatic stress disorder, resilience
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Adult Congenital Heart Association
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall cohort | – | Behavioral: OtherAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult with a congenital heart disease diagnosis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Any who opt out
- Age < 18 years
- No diagnosis of congenital heart disease
- Not enrolled in CHI registry/unable to access Internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtherAlso: Assessment of PTSD symptoms and resilienceSurveys will be distributed for data collection. A subset of patients will participate in diagnostic clinician interviews. No interventions will be tested. | Behavioural | Overall cohort |
Primary outcome
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.
2 secondary outcomes
Clinician Administered PTSD Scale Diagnostic Interview (CAPS-5)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 24589850Webb 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.
- Background: PubMed 38846320Steiner 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.
- Background: PubMed 38133788Phillippi 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.
- Background: PubMed 38458583Harrison 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.
- Congenital Heart Initiative enrollment pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie Jackson, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Congenital Heart Disease and Congenital Heart Disease, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David J Harrison, MD (603-650-5724, david.j.harrison@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD checklist for DSM-5 (PCL-5) (time frame: One-time survey. Distribute to patients during months ~1-2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952933, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.