18 and older, any sex, with Cardiac Arrest or Post Traumatic Stress Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot StudyPrimary· Baseline (ICU admittance)
This is to assess feasibility of recruitment. Potential family member participants whom the study team approaches and agree/consent to take part in the study will be tallied.
Specifically, we divided the number of family member participants who enrolled in the study by the number of potential participants referred to the study (enrolled/referred).
Group
Value
95% CI
All Referrals to FAID Fear
16
All Referrals to FAID Fear
4
All Referrals to FAID Fear
5
Proportion of Enrolled Family Members Who Complete the Pilot StudyPrimary· 30 days post-discharge
This is to estimate/assess retention. Family members who remain in the study at the final assessment will be tallied.
Specifically, we divided the number of family member participants who completed the study by the number of potential participants who did not complete the study (completed/did not complete).
Group
Value
95% CI
All FAID Fear Enrollments
14
All FAID Fear Enrollments
2
Proportion of Family Members That Adhere to the Diary InterventionSecondary· Up to hospital discharge (approximately 21 days)
This is to assess acceptability of study procedures. Family members who report completing at least 2 diary entries/week will be tallied.
Specifically, we divided the number of family member participants in the diary intervention who adhered to the intervention by the number of participants who did not adhere to the intervention (adhered/did not adhere).
Group
Value
95% CI
FAID Fear Intervention
7
FAID Fear Intervention
4
Proportion of Family Members That Complete the Majority of Survey AssessmentsSecondary· Up to 30 days post-discharge
This is to assess acceptability of study procedures. Family members who complete at least 90% of survey assessments will be tallied.
Specifically, we divided the number of family member participants who completed at least 90% of survey assessments by the number of family member participants who completed less than 90% of survey assessments (completed/did not complete).
Group
Value
95% CI
All FAID Fear Enrollments
14
All FAID Fear Enrollments
2
Proportion of Family Members That Agree That the Intervention Was AcceptableSecondary· 30 days post-discharge
As a measure of intervention acceptability, study will assess the proportion of participants who agree that the intervention was acceptable for reducing cardiac anxiety about the patient's heart using mean of the 4-item Acceptability of Intervention Measure (score \>= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.
Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was acceptable by the number of family member participants in the diary intervention who did not agree that the interve
Group
Value
95% CI
FAID Fear Intervention
8
FAID Fear Intervention
2
Proportion of Family Members That Agree That the Intervention Was FeasibleSecondary· 30 days post-discharge
As a measure of intervention acceptability, study will assess the proportion of participants who agree that the study was feasible using the mean of the 4-item Feasibility of Intervention Measure (score \>= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.
Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was feasible by the number of family member participants in the diary intervention who did not agree that the intervention was feasible (feasible/not feasible).
Group
Value
95% CI
FAID Fear Intervention
9
FAID Fear Intervention
1
Proportion of Family Members That Agree That the Intervention Was AppropriateSecondary· 30 days post-discharge
As a measure of intervention acceptability, study will assess the proportion of participants who agree that the study was appropriate for reducing cardiac anxiety about the patient's heart using the 4-item Intervention Appropriateness Measure (score \>= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.
Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was appropriate by the number of family member participants in the diary intervention who did not agree that the intervention was appr
Group
Value
95% CI
FAID Fear Intervention
7
FAID Fear Intervention
3
Cardiac Anxiety Questionnaire Fear Subscale ScoreSecondary· Hospital discharge (approximately 21 days), 30 days post-discharge
This is to measure family members' cardiac anxiety about the patients' heart. Cardiac anxiety will be measured using the 8-item fear subscale of the Cardiac Anxiety Questionnaire and compared between intervention and control participants (higher scores indicate greater fear; 1 = never, 5 = always). Possible mean scores range from 1 to 5.
This is to measure family members' aversive cognitions towards patients' exercise. Aversive cognitions towards exercise will be measured using the 5-item avoidance subscale of the Cardiac Anxiety Questionnaire and compared between intervention and control participants (higher scores indicate greater aversive cognitions; 1 = never, 5 = always). Possible mean scores range from 1 to 5.
End of Hospital Care
Group
Value
95% CI
FAID Fear Intervention
3.56
± 1.14
Control Condition - Usual Care
3.45
± 0.53
30 Days After End of Hospital Care
Group
Value
95% CI
FAID Fear Intervention
3.16
± 1.07
Control Condition - Usual Care
3.35
± 0.72
Posttraumatic Stress Disorder Checklist ScoreSecondary· 30 days post-discharge
This is to measure family members' posttraumatic stress symptoms in relation to the patients' cardiac arrest at discharge. Posttraumatic stress symptoms will be measured using the sum of the 20-item Posttraumatic Stress Disorder Checklist cued to the CA-event and related hospitalization and compared between intervention and control participants. A score \>=33 is considered a positive screen for PTSD (higher scores indicate greater PTSD symptoms; 0 = not at all, 4 = extremely). Possible total scores range from 0 to 80.
Group
Value
95% CI
FAID Fear Intervention
19.70
± 12.83
Control Condition - Usual Care
11.00
± 4.08
Sponsor's own description
The present study will:
Aim 1: Enroll 15 family members of CA patients to (a) pilot recruitment procedures, (b) estimate retention, and (c) assess acceptability of study procedures.
Family members will be randomized to either complete an ICU diary or to a control condition, and will complete surveys in the ICU, at patient discharge, and 30 days post-discharge.
Aim 2: Obtain an estimate of the association of intervention v. control with (i) family member fear (operationalized as cardiac anxiety about the patients' cardiac condition) at hospital discharge and (ii) family member PTSS 30 days post-discharge.
Exploratory Aims: Obtain an estimate of the association of intervention v. control with family member aversive cognitions towards exercise at hospital discharge.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Columbia University
Last refreshed: 28 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05144477.