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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled
Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.
Time frame: 0 weeks
Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.
Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.
Time frame: Pre-test (0 weeks) to post-test (6 weeks)
Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.
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.
Time frame: Pre-test (0 weeks) to post-test (6 weeks)
Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.
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.
Time frame: Pre-test (0 weeks) to post-test (6 weeks)
Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).
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.
Time frame: Post-test (6 weeks)
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Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire
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.
Time frame: Pre-test (0 weeks)
Mean Change in the Hospital Depression and Anxiety Scale Total Score.
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Dyadic Relationship Scale Sub Scales
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Dyadic Coping Inventory Sub Scales
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Applied Mindfulness Scale Total Score.
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Preparedness for Caregiving Scale Total Score
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).
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Mean Change in Meaning in Life Questionnaire Sub Scales
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)
Gratitude Questionnaire Six Item Form
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.
Time frame: Pre-test (0 weeks), Post-Test (6 weeks)