Anxiety, Cardiac Arrest (CA), Caregivers, Depression, Emotional Distress, Mindfulness, Resilience, Survivorship
Conditions
Keywords
emotional distress, cardiac arrest, cardiac arrest survivorship, caregivers, resilience, mindfulness, mind-body, behavioral interventions, anxiety, depression
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRecovering Together after Cardiac Arrest 1
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.
OTHERRecovering Together after Cardiac Arrest 2
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. survivor must score \>5 on Short Form of the Mini Mental State Exam for sufficient cognitive function for meaningful participation 3. ability and willingness to participate in a hybrid in-person/live video intervention 4. English speaking adults (18 year or older) 5. at least one member of the dyad endorses clinically significant emotional distress during screening (\>7 on either of the Hospital Anxiety and Depression Scale subscales).
Exclusion criteria
1. active psychosis, mania, substance dependence, or suicidal intent or plan that would require a higher level of care 2. any other psychiatric or neurological condition that would preclude meaningful participation 3. the caregiver must not be a cardiac arrest survivor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | pre-test | Proportion of eligible dyads that consent to participation |
| Feasibility of Randomization | The end of treatment at 6 weeks | Proportion of randomized participants who submit post-test assessments |
| Feasibility of Assessment Completion | pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment | Proportion of participants with no assessment measures missing at pre-test, post-test, and 3 month follow-up |
| Feasibility of Program Adherence (RT-CA 1) | the end of treatment at 6 weeks | Proportion of RT-CA 1 dyads that initiate the program by attending session 1 and complete at least 4 of 6 sessions. |
| Therapist Fidelity | the end of treatment at 6 weeks | Proportion of 20% randomly-selected RT-CA 1 sessions in which the therapist fully adheres to program content, ascertained by a fidelity checklist |
| Treatment Satisfaction (RT-CA 1) | the end of treatment at 6 weeks | Proportion of RT-CA 1 participants that endorse satisfaction, defined as above the midpoint on the Client Satisfaction Questionnaire-3 |
| Credibility (RT-CA 1) | pre-test | 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 |
| Expectancy (RT-CA 1) | pre-test | 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 |
| Study safety | at the end of treatment at 6 weeks and 3 months after the end of treatment | The proportion of participants that report no adverse events related to study participation. |
Countries
United States
Contacts
Primary ContactAlexander Presciutti, PhD
Backup ContactSara Bogan, BA
Outcome results
None listed