N/A
Completed N=14
Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers
Emotional Distress · Cardiac Arrest
Source: ClinicalTrials.gov NCT06517394 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled — 7 dyads
Summary
The purpose of this study is to pilot a mind-body intervention for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest. The data the investigators gather in this study will be used to further refine our intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled |
7 | — |
| PRIMARY Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires. |
7; 7 | — |
| PRIMARY Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions. |
7 | — |
| PRIMARY Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content. |
7 | — |
| PRIMARY Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5). |
14 | — |
| PRIMARY Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire |
7; 4; 6; 1 | — |
| SECONDARY Mean Change in the Hospital Depression and Anxiety Scale Total Score. |
-10.6; -6.6 | — |
| SECONDARY Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score. |
-17.6; -6.3 | — |
| SECONDARY Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score |
5.4; 1.5 | — |
| SECONDARY Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score |
1.9; 0 | — |
| SECONDARY Mean Change in Measure of Current Status Part A (MOCS-A) Average Score. |
0.3; 0.2 | — |
| SECONDARY Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores |
2.2; -0.08; 1; 0.5; 1; -0.4 | — |
| SECONDARY Mean Change in Dyadic Relationship Scale Sub Scales |
0; 0.3; 0.1; 0.7 | — |
| SECONDARY Mean Change in Dyadic Coping Inventory Sub Scales |
0; 2.6; 1.9; 0.8; 2.2; 1.9 | — |
| SECONDARY Mean Change in Applied Mindfulness Scale Total Score. |
-2.5; 2.7 | — |
| SECONDARY Mean Change in Preparedness for Caregiving Scale Total Score |
5.4; 3.1 | — |
| SECONDARY Mean Change in Meaning in Life Questionnaire Sub Scales |
-2.2; 0.2; -5; 0.5 | — |
| SECONDARY Gratitude Questionnaire Six Item Form |
-0.9; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Out-of-hospital or in-hospital CA survivor (must have new diagnosis of "cardiac arrest" in electronic medical record from index hospitalization with documented loss of pulse) with an identified caregiver (identified by the survivor who is their primary source of emotional and functional support)
- Score ≥4 on Short Form of the Mini Mental State Exam
- Ability and willingness to participate in a hybrid in-person/live video or phone intervention
- English speaking adults, 18 years or older
- At least one member of the dyad endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression Scale subscales)
Exclusion Criteria
- Active psychosis, mania, substance dependence, or suicidal intent or plan
Data sourced from ClinicalTrials.gov (NCT06517394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.