Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers
- Conditions
- Cardiac ArrestEmotional Distress
- Interventions
- Behavioral: Recovering Together after Cardiac Arrest
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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)
- Active psychosis, mania, substance dependence, or suicidal intent or plan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Recovering Together after Cardiac Arrest Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.
- Primary Outcome Measures
Name Time Method Assessment feasibility Pre-test (0 weeks) to post-test (6 weeks) Number of CA survivor-caregiver dyads with no measures missing on all self-report questionnaires assessed using frequencies and proportions.
Therapist fidelity Pre-test (0 weeks) to post-test (6 weeks) Number of sessions in which the therapist adhered 100% to the treatment manual assessed using frequencies and proportions.
Recruitment feasibility 0 weeks Number of eligible CA survivor-caregiver dyads that enroll in the intervention assessed using frequencies and proportions.
Credibility and Expectancy Questionnaire Pre-test (0 weeks), Post-test (6 weeks) Number of CA survivor-caregiver dyads who score above the scale's midpoint assessed using frequencies and proportions.
Adherence feasibility Pre-test (0 weeks) to post-test (6 weeks) The number of CA survivor-caregiver dyads who complete 4/6 intervention sessions assessed using frequencies and proportions.
Client Satisfaction Questionnaire Post-test (6 weeks) Number of CA survivor-caregiver dyads who score above the scale's midpoint assessed using frequencies and proportions.
- Secondary Outcome Measures
Name Time Method Hospital Depression and Anxiety Scale Pre-test (0 weeks), Post-Test (6 weeks) 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.
Dyadic Relationship Scale 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.
Enhancing Recovery in Coronary Heart Disease Social Support Inventory 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.
Measure of Current Status Part A (MOCS-A) 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 range from 0 to 52.
Dyadic Coping Inventory Pre-test (0 weeks), Post-Test (6 weeks) Assesses self-reported coping behaviors when dyad faces stressors; scores range from 35-175; higher scores reflect more adaptive coping.
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.
Post-Traumatic Stress Disorder Checklist - 5 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.
The Cognitive and Affective Mindfulness Scale-Revised Pre-test (0 weeks), Post-Test (6 weeks) Measures dispositional mindfulness, total scores range from 12-48, higher values reflect higher levels of mindfulness.
Applied Mindfulness Scale 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.
Preparedness for Caregiving Scale Pre-test (0 weeks), Post-Test (6 weeks) 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.
World Health Organization Quality of Life-Brief 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.
Anxiety Sensitivity Index (4 cardiac items) Pre-test (0 weeks), Post-Test (6 weeks) 4 items pulled from 16-item questionnaire measuring fear of anxiety. The 4 items relate to cardiac symptoms.
Meaning in Life Questionnaire 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).
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States