The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.
The goal of this study is to test the feasibility of our proposed interventions through a pilot RCT. The investigators will deliver the RCT intervention (N=42 dyads; 84 participants total) and evaluate feasibility and acceptability based on a priori benchmarks. The RCT will initially take place at Massachusetts General Hospital intensive care units and step-down units. Cardiac arrest survivor-caregiver dyads will be randomly assigned to one of two groups - Recovering Together after Cardiac Arrest 1 (RT-CA 1) or Recovering Together after Cardiac Arrest 2 (RT-CA 2). RT-CA 1 involves six, 30-minute weekly sessions beginning at bedside and continuing over Zoom after the survivor is discharged. RT-CA 2 involves one, 30 minute session at bedside. All participants will complete psychosocial survey measures at baseline, six weeks, and 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
The intervention will teach resiliency skills (mindfulness and coping) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person until the survivor is discharged; remaining sessions will occur over Zoom.
In this minimally enhanced usual care control, dyads will participate in one 30-minute session with a clinician at beside to review a pamphlet of available psychosocial resources for cardiac arrest survivors and their caregivers.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGFeasibility of Recruitment
Proportion of eligible dyads that consent to participation
Time frame: pre-test
Feasibility of Randomization
Proportion of randomized participants who submit post-test assessments
Time frame: The end of treatment at 6 weeks
Feasibility of Assessment Completion
Proportion of participants with no assessment measures missing at pre-test, post-test, and 3 month follow-up
Time frame: pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment
Feasibility of Program Adherence (RT-CA 1)
Proportion of RT-CA 1 dyads that initiate the program by attending session 1 and complete at least 4 of 6 sessions.
Time frame: the end of treatment at 6 weeks
Therapist Fidelity
Proportion of 20% randomly-selected RT-CA 1 sessions in which the therapist fully adheres to program content, ascertained by a fidelity checklist
Time frame: the end of treatment at 6 weeks
Treatment Satisfaction (RT-CA 1)
Proportion of RT-CA 1 participants that endorse satisfaction, defined as above the midpoint on the Client Satisfaction Questionnaire-3
Time frame: the end of treatment at 6 weeks
Credibility (RT-CA 1)
Proportion of RT-CA 1 participants that endorse program credibility at pre-test, defined as scoring above the midpoint on the Credibility sub scale of the Credibility/Expectancy Questionnaire
Time frame: pre-test
Expectancy (RT-CA 1)
Proportion of RT-CA 1 participants that endorse expectancy to improve. from the program at pre-test, defined as scoring above the midpoint on the Expectancy sub scale of the Credibility/Expectancy Questionnaire
Time frame: pre-test
Study safety
The proportion of participants that report no adverse events related to study participation.
Time frame: at the end of treatment at 6 weeks and 3 months after the end of treatment
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