Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Any who opt out
Age < 18 years
No diagnosis of congenital heart disease
Not enrolled in CHI registry/unable to access Internet
Trial population
Any adult with a congenital heart disease diagnosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Other
BehavioralSurveys will be distributed for data collection. A subset of patients will participate in diagnostic clinician interviews. No interventions will be tested.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Overall cohort1 intervention
Trial outcomes
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.
Time frame
One-time survey. Distribute to patients during months ~1-2.Secondary outcomes
1
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.
Time frame
One-time interview during study months 4 to 122
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.
Time frame
One-time survey. Distribute to patients during months ~1-2.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
Adult Congenital Heart Association
Collaborator
Source ClinicalTrials.gov