Clinical trial NCT06517394: Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers
Official title: Open Pilot Trial of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Distress
Cardiac Arrest
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment feasibility
timeFrame: 0 weeks
measure: Assessment feasibility
timeFrame: Pre-test (0 weeks) to post-test (6 weeks)
measure: Adherence feasibility
timeFrame: Pre-test (0 weeks) to post-test (6 weeks)
measure: Therapist fidelity
timeFrame: Pre-test (0 weeks) to post-test (6 weeks)
measure: Client Satisfaction Questionnaire
timeFrame: Post-test (6 weeks)
measure: Credibility and Expectancy Questionnaire
timeFrame: Pre-test (0 weeks), Post-test (6 weeks)
Secondary outcomes:
measure: Hospital Depression and Anxiety Scale
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Post-Traumatic Stress Disorder Checklist - 5
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: The Cognitive and Affective Mindfulness Scale-Revised
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Enhancing Recovery in Coronary Heart Disease Social Support Inventory
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Measure of Current Status Part A (MOCS-A)
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: World Health Organization Quality of Life-Brief
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Dyadic Relationship Scale
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Dyadic Coping Inventory
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Applied Mindfulness Scale
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Preparedness for Caregiving Scale
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Meaning in Life Questionnaire
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Anxiety Sensitivity Index (4 cardiac items)
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Gratitude Questionnaire Six Item Form
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
Other outcomes:
measure: Barthel Index
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Modified Rankin Scale
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Telephone Interview for Cognitive Status 40
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
measure: Cerebral Performance Category Scale
timeFrame: Pre-test (0 weeks), Post-Test (6 weeks)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alexander M Presciutti, PhD
role: PRINCIPAL_INVESTIGATOR
References: