Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-01 @ 1:12 AM
Study NCT ID:
NCT06952933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Study Overview
Official Title:
Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTSD in ACHD
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: