Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers
NCT Number: NCT06517394
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotional Distress|Cardiac Arrest
Interventions: BEHAVIORAL: Recovering Together after Cardiac Arrest
Sponsor: Massachusetts General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-07-31

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.

Primary Outcome Measures: Recruitment feasibility, Number of eligible CA survivor-caregiver dyads that enroll in the intervention assessed using frequencies and proportions., 0 weeks|Assessment feasibility, Number of CA survivor-caregiver dyads with no measures missing on all self-report questionnaires assessed using frequencies and proportions., Pre-test (0 weeks) to post-test (6 weeks)|Adherence feasibility, The number of CA survivor-caregiver dyads who complete 4/6 intervention sessions assessed using frequencies and proportions., Pre-test (0 weeks) to post-test (6 weeks)|Therapist fidelity, Number of sessions in which the therapist adhered 100% to the treatment manual assessed using frequencies and proportions., Pre-test (0 weeks) to post-test (6 weeks)|Client Satisfaction Questionnaire, Number of CA survivor-caregiver dyads who score above the scale's midpoint assessed using frequencies and proportions., Post-test (6 weeks)|Credibility and Expectancy Questionnaire, Number of CA survivor-caregiver dyads who score above the scale's midpoint assessed using frequencies and proportions., Pre-test (0 weeks), Post-test (6 weeks)
Secondary Outcome Measures: Hospital Depression and Anxiety Scale, Assesses anxiety and depression in medical patients. Anxiety and depression subscale ranges from 0-21; a score above a 7 on either the anxiety or depression subscale indicates clinically significant symptoms., Pre-test (0 weeks), Post-Test (6 weeks)|Post-Traumatic Stress Disorder Checklist - 5, 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., Pre-test (0 weeks), Post-Test (6 weeks)|The Cognitive and Affective Mindfulness Scale-Revised, Measures dispositional mindfulness, total scores range from 12-48, higher values reflect higher levels of mindfulness., Pre-test (0 weeks), Post-Test (6 weeks)|Enhancing Recovery in Coronary Heart Disease Social Support Inventory, 7-item measure that assesses perceived social support. Higher scores indicate greater social support. Total scores range from 8 to 34., Pre-test (0 weeks), Post-Test (6 weeks)|Measure of Current Status Part A (MOCS-A), 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 range from 0 to 52., Pre-test (0 weeks), Post-Test (6 weeks)|World Health Organization Quality of Life-Brief, 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., Pre-test (0 weeks), Post-Test (6 weeks)|Dyadic Relationship Scale, 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., Pre-test (0 weeks), Post-Test (6 weeks)|Dyadic Coping Inventory, Assesses self-reported coping behaviors when dyad faces stressors; scores range from 35-175; higher scores reflect more adaptive coping., Pre-test (0 weeks), Post-Test (6 weeks)|Applied Mindfulness Scale, 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., Pre-test (0 weeks), Post-Test (6 weeks)|Preparedness for Caregiving Scale, Self-report measure assessing caregiver's perceptions of preparedness to care for their loved one. Each item is rated on a 5-point Likert scale with scales ranging from 0 to 4. Scores are calculated by taking the mean of all items. Higher scores indicate greater preparedness., Pre-test (0 weeks), Post-Test (6 weeks)|Meaning in Life Questionnaire, 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)., Pre-test (0 weeks), Post-Test (6 weeks)|Anxiety Sensitivity Index (4 cardiac items), 4 items pulled from 16-item questionnaire measuring fear of anxiety. The 4 items relate to cardiac symptoms., 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., Pre-test (0 weeks), Post-Test (6 weeks)
Other Outcome Measures: Barthel Index, A 10-item ordinal scale that measures functional independence in the domains of personal care and mobility. Specifically, it measures self-care, transfers and locomotion., Pre-test (0 weeks), Post-Test (6 weeks)|Modified Rankin Scale, Assesses degree of disability after a neurological injury on a scale of 0 to 6. Higher scores indicate greater disability., Pre-test (0 weeks), Post-Test (6 weeks)|Telephone Interview for Cognitive Status 40, Cognitive screening assessment administered over the phone. Lower scores indicate greater cognitive impairment., Pre-test (0 weeks), Post-Test (6 weeks)|Cerebral Performance Category Scale, Assesses cardiac arrest patient's post-arrest neurologic functioning. The scale ranges from 1 to 5. 1 indicate good cerebral performance and 5 indicate brain death., Pre-test (0 weeks), Post-Test (6 weeks)