Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers

Not Applicable

Completed

• Conditions: Cardiac Arrest; Emotional Distress

• Registration Number: NCT06517394
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

The goal of this study is to refine our proposed intervention Recovering Together after Cardiac Arrest (RT-CA) through an open pilot. The investigators will deliver an open pilot of the intervention (N=5 dyads; 10 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.

The open pilot will take place at Massachusetts General Hospital intensive care units and step-down units. Study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on Zoom/telephone, depending on participant preference and access). All participants will complete measures at baseline, and after completion of program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback of the intervention.

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Study Start: 2024-08-01
• Primary Completion: 2025-04-09
• Study Completion: 2025-04-16
• Results First Submitted: 2025-06-20
• Status Verified: 2025-10
• Results First Submitted QC: 2025-10-21
• Last Update Submitted: 2025-10-21
• Results First Posted: 2025-11-05
• Last Update Posted: 2025-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. 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)
2. Score ≥4 on Short Form of the Mini Mental State Exam
3. Ability and willingness to participate in a hybrid in-person/live video or phone intervention
4. English speaking adults, 18 years or older
5. At least one member of the dyad endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression Scale subscales)

Exclusion Criteria

1. Active psychosis, mania, substance dependence, or suicidal intent or plan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled	0 weeks	Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.
Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.	Pre-test (0 weeks) to post-test (6 weeks)	Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.
Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.	Pre-test (0 weeks) to post-test (6 weeks)	Adherence feasibility was assessed by the number of CA survivor-caregiver dyads who begin the intervention and adhere to it by completing at least 4 of 6 intervention sessions.
Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.	Pre-test (0 weeks) to post-test (6 weeks)	Number of sessions in which the therapist adhered 100% to the treatment manual. The study coordinator listened to 9 random RT-CA sessions, and, using a checklist, identified whether the study clinician fully adhered to the content of each session by delivering each key ingredient of the session.
Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).	Post-test (6 weeks)	The proportion of participants that scored above the midpoint on the Client Satisfaction Questionnaire-3 (CSQ-3), which assesses satisfaction with a program. Total scores range from 3-12 (midpoint 7.5); higher scores indicate greater satisfaction.
Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire	Pre-test (0 weeks)	Number of individuals that score above the midpoint on each sub-scale of the Credibility and Expectancy Questionnaire (CEQ). Through two subscales, the CEQ assesses participants' perceptions that a program is logical (credible) and their expectancy that participation would lead to improvements (expectancy). Scores on the credibility subscale range from 3-27 (midpoint 15) and scores on the expectancy factor range from 3-31 (midpoint 17); higher scores on each indicate greater credibility and expectancy.

Secondary Outcome Measures

Name	Time	Method
Mean Change in the Hospital Depression and Anxiety Scale Total Score.	Pre-test (0 weeks), Post-Test (6 weeks)	Assesses emotional distress in medical patients; total scale ranges from 0-42, higher scores represent worse distress. A negative mean change in the total score means emotional distress improved.
Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.	Pre-test (0 weeks), Post-Test (6 weeks)	20-item questionnaire that measures post-traumatic stress disorder symptoms. Scores range from 0 to 80, with higher scores indicating greater severity and intensity of symptoms. A negative change in the total score represents improvement in symptoms.
Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score	Pre-test (0 weeks), Post-Test (6 weeks)	Measures dispositional mindfulness, total scores range from 12-48, higher values reflect higher levels of mindfulness. A positive mean change in the total score reflected increased dispositional mindfulness.
Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score	Pre-test (0 weeks), Post-Test (6 weeks)	7-item measure that assesses perceived social support. Higher scores indicate greater social support. Total scores range from 8 to 34. A positive mean change in the total score indicates increases in perceived social support.
Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.	Pre-test (0 weeks), Post-Test (6 weeks)	Assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Higher scores indicate a stronger ability to recognize stress and cope. Scores are averaged and range from 0-4. A positive change in the MOCS-A average score indicates improvements in coping.
Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores	Pre-test (0 weeks), Post-Test (6 weeks)	26-item measure assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Higher scores indicate higher quality of life for all domains. Scores in each domain range from 4 to 20. Scores were assessed at pre- and post-test; a positive mean change score in each domain indicates improved quality f life.
Mean Change in Dyadic Relationship Scale Sub Scales	Pre-test (0 weeks), Post-Test (6 weeks)	Questionnaire that assesses perceptions of dyadic interactions from both members of the relationship. The caregiver version is 11 items and the patient version is 10 items. Scores are calculated for two subscales: dyadic strain (scores range from 0-15) and positive interactions (scores range from 0-18). Lower scores on the dyadic strain subscale and greater scores on the positive interactions subscale indicate fewer relationship stressors and more positive aspects of the relationship.
Mean Change in Dyadic Coping Inventory Sub Scales	Pre-test (0 weeks), Post-Test (6 weeks)	Measures perceived quality of dyad's communication and proficiency in using adaptive dyadic coping skills. Subscales are summed for a total subscale score. Higher scores indicate greater quality communication and/or coping.; Stress communicated by oneself measures how well stress is communicated by oneself to their partner Range 4-20.; Stress communicated by one's partner Measures how well one's partner communicates about their stress. Range 4-20.; Supportive coping provided by one's partner Measures the quality of emotional and/or problem-focused support provided by one's partner Range 5-25.; Negative dyadic coping by one's partner Measures the degree that one's partner uses hostile, ambivalent, and superficial actions/words that have deleterious intentions. Range 4-20.; Joint or common coping Measures the degree to which dyads work together to manage stress.Range 5-25.; Evaluation of dyadic coping Measures perception of the quality of the dyad's approach to coping.Range 2-10.
Mean Change in Applied Mindfulness Scale Total Score.	Pre-test (0 weeks), Post-Test (6 weeks)	15-item questionnaire measuring how participants use mindfulness when facing stressors. Scores range from 0 to 60 with higher scores indicating greater use of mindfulness practices.
Mean Change in Preparedness for Caregiving Scale Total Score	Pre-test (0 weeks), Post-Test (6 weeks)	For caregivers, this scale measures caregiver preparedness to care for survivor. In this study, for survivor participants, we adapted the language to measure preparedness to care for oneself. Scores range from 0 to 32 Higher scores indicate greater perceived readiness for caregiving (for caregivers) or for survivorship (for survivors).
Mean Change in Meaning in Life Questionnaire Sub Scales	Pre-test (0 weeks), Post-Test (6 weeks)	10 items measuring presence of meaning and purpose in life. Assesses two dimensions: presence and search. Items are rated on a 7-point scale from 1 (Absolutely Untrue) to 7 (Absolutely True). Both presence of meaning and search for meaning subscale scores range from 5-35. Higher scores indicate greater presence and search.
Gratitude Questionnaire Six Item Form	Pre-test (0 weeks), Post-Test (6 weeks)	Measures participant's gratitude disposition. Each item is rated on a 7-point Likert scale. Scores range from 6 to 42. Higher scores indicate a more grateful disposition.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States