Trial Outcomes & Findings for Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers (NCT NCT06517394)
NCT ID: NCT06517394
Last Updated: 2025-11-05
Results Overview
Number of sessions in which the therapist adhered 100% to the treatment manual. The study coordinator listened to 9 random RT-CA sessions, and, using a checklist, identified whether the study clinician fully adhered to the content of each session by delivering each key ingredient of the session.
COMPLETED
NA
14 participants
Pre-test (0 weeks) to post-test (6 weeks)
2025-11-05
Participant Flow
Participant milestones
| Measure |
Intervention
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.
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|---|---|
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Overall Study
STARTED
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14
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
14 total participants (7 dyads) participated
Baseline characteristics by cohort
| Measure |
Intervention
n=14 Participants
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.
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Ethnicity (NIH/OMB)
Survivors · Unknown or Not Reported
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
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7 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Survivors · American Indian or Alaska Native
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Survivors · Asian
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Survivors · Native Hawaiian or Other Pacific Islander
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Survivors · Black or African American
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Survivors · White
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7 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Survivors · More than one race
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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|
Race (NIH/OMB)
Survivors · Unknown or Not Reported
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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|
Race (NIH/OMB)
Caregivers · Asian
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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|
Race (NIH/OMB)
Caregivers · Black or African American
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Caregivers · White
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7 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Caregivers · More than one race
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Race (NIH/OMB)
Caregivers · Unknown or Not Reported
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Marital Status
Survivors
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5 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Marital Status
Caregivers
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5 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Age, Categorical
Survivors · <=18 years
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Age, Categorical
Survivors · Between 18 and 65 years
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3 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Age, Categorical
Survivors · >=65 years
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4 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Age, Categorical
Caregivers · <=18 years
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Age, Categorical
Caregivers · Between 18 and 65 years
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4 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Age, Categorical
Caregivers · >=65 years
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3 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Sex: Female, Male
Survivors · Female
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4 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Sex: Female, Male
Survivors · Male
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3 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Sex: Female, Male
Caregivers · Female
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4 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Sex: Female, Male
Caregivers · Male
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3 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Ethnicity (NIH/OMB)
Survivors · Hispanic or Latino
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0 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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Ethnicity (NIH/OMB)
Survivors · Not Hispanic or Latino
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7 Participants
n=7 Participants • 14 total participants (7 dyads) participated
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PRIMARY outcome
Timeframe: 0 weeksPopulation: Analysis population (unit) was the dyad. We analyzed 8 dyads (8 survivors and 8 caregivers or 16 participants total).
Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.
Outcome measures
| Measure |
Intervention
n=8 dyads
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled
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7 dyads
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PRIMARY outcome
Timeframe: Pre-test (0 weeks) to post-test (6 weeks)Population: We analyzed 14 individual participants (7 survivors and 7 caregivers) for this benchmark, not dyads.
Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.
Survivors
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7 Participants
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Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.
Caregivers
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7 Participants
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PRIMARY outcome
Timeframe: Pre-test (0 weeks) to post-test (6 weeks)Population: We analyzed 7 units (dyads), which is comprised of 14 participants (7 survivors and 7 caregivers).
Adherence feasibility was assessed by the number of CA survivor-caregiver dyads who begin the intervention and adhere to it by completing at least 4 of 6 intervention sessions.
Outcome measures
| Measure |
Intervention
n=7 dyads
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.
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7 dyads
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PRIMARY outcome
Timeframe: Pre-test (0 weeks) to post-test (6 weeks)Population: Each unit of analysis was a session recording listened to at random by the research coordinator, which they rated the degree to which the study clinician delivered all key ingredients (rated as fully adherent or not adherent).
Number of sessions in which the therapist adhered 100% to the treatment manual. The study coordinator listened to 9 random RT-CA sessions, and, using a checklist, identified whether the study clinician fully adhered to the content of each session by delivering each key ingredient of the session.
Outcome measures
| Measure |
Intervention
n=9 Sessions
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.
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7 Sessions
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PRIMARY outcome
Timeframe: Post-test (6 weeks)Population: Analysis population was number of participants that scores above the midpoint on the CSQ-3, not dyads.
The proportion of participants that scored above the midpoint on the Client Satisfaction Questionnaire-3 (CSQ-3), which assesses satisfaction with a program. Total scores range from 3-12 (midpoint 7.5); higher scores indicate greater satisfaction.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).
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14 Participants
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PRIMARY outcome
Timeframe: Pre-test (0 weeks)Population: For credibility and expectancy, we analyzed individual participant responses on each sub scale (Credibility and expectancy).
Number of individuals that score above the midpoint on each sub-scale of the Credibility and Expectancy Questionnaire (CEQ). Through two subscales, the CEQ assesses participants' perceptions that a program is logical (credible) and their expectancy that participation would lead to improvements (expectancy). Scores on the credibility subscale range from 3-27 (midpoint 15) and scores on the expectancy factor range from 3-31 (midpoint 17); higher scores on each indicate greater credibility and expectancy.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire
Survivors that endorsed credibility
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7 Participants
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Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire
Caregivers that endorsed credibility
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4 Participants
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Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire
Survivors that endorsed expectancy
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6 Participants
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Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire
Caregivers that endorsed expectancy
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1 Participants
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SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: Analyzed change in total score in individual survivors and caregivers
Assesses emotional distress in medical patients; total scale ranges from 0-42, higher scores represent worse distress. A negative mean change in the total score means emotional distress improved.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Mean Change in the Hospital Depression and Anxiety Scale Total Score.
Survivors
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-10.6 mean change units on a scale
Interval -14.6 to -6.6
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Mean Change in the Hospital Depression and Anxiety Scale Total Score.
Caregivers
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-6.6 mean change units on a scale
Interval -11.2 to -1.9
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SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: Analyzed change in 7 survivors and 7 caregivers
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. A negative change in the total score represents improvement in symptoms.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.
Survivors
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-17.6 mean change units on a scale
Interval -34.0 to -1.1
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Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.
Caregivers
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-6.3 mean change units on a scale
Interval -11.0 to -1.6
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SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: Analyzed change in 7 survivors and 7 caregivers
Measures dispositional mindfulness, total scores range from 12-48, higher values reflect higher levels of mindfulness. A positive mean change in the total score reflected increased dispositional mindfulness.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score
Survivors
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5.4 mean change units on a scale
Interval 0.4 to 10.4
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Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score
Caregivers
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1.5 mean change units on a scale
Interval -2.5 to 5.4
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SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: Analyzed change in 7 survivors and 7 caregivers
7-item measure that assesses perceived social support. Higher scores indicate greater social support. Total scores range from 8 to 34. A positive mean change in the total score indicates increases in perceived social support.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score
Survivors
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1.9 change in units on a scale
Interval -1.0 to 4.8
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Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score
Caregivers
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0 change in units on a scale
Interval -3.7 to 3.7
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SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: Analyzed change in 7 survivors and 7 caregivers
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 are averaged and range from 0-4. A positive change in the MOCS-A average score indicates improvements in coping.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.
caregivers
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0.2 change in units on a scale
Interval -0.4 to 0.9
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Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.
survivors
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0.3 change in units on a scale
Interval -0.3 to 0.9
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SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: 7 survivors and 7 caregivers
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. Scores were assessed at pre- and post-test; a positive mean change score in each domain indicates improved quality f life.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
survivors phys QOL
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2.2 change in units on a scale
Interval -0.9 to 5.3
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Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
caregivers phys QOL
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-0.08 change in units on a scale
Interval -0.5 to 0.4
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Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
survivors psych QOL
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1 change in units on a scale
Interval -0.3 to 2.4
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Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
caregivers psych QOL
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0.5 change in units on a scale
Interval -0.5 to 1.5
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Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
survivors soc QOL
|
1 change in units on a scale
Interval -1.4 to 3.3
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Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
caregivers soc QOL
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-0.4 change in units on a scale
Interval -1.6 to 0.8
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Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
survivors env QOL
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-0.4 change in units on a scale
Interval -1.3 to 0.5
|
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Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores
caregivers env QOL
|
-0.07 change in units on a scale
Interval -1.1 to 0.9
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SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: 7 survivors 7 caregivers
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.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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|---|---|
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Mean Change in Dyadic Relationship Scale Sub Scales
survivors positive
|
0 change in units on a scale
Interval -5.1 to 5.1
|
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Mean Change in Dyadic Relationship Scale Sub Scales
caregivers positive
|
0.3 change in units on a scale
Interval -1.2 to 1.8
|
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Mean Change in Dyadic Relationship Scale Sub Scales
survivors strain
|
0.1 change in units on a scale
Interval -4.0 to 3.7
|
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Mean Change in Dyadic Relationship Scale Sub Scales
caregivers strain
|
0.7 change in units on a scale
Interval -1.1 to 2.5
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SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: Analyzed change in 7 survivors and 7 caregivers
Measures perceived quality of dyad's communication and proficiency in using adaptive dyadic coping skills. Subscales are summed for a total subscale score. Higher scores indicate greater quality communication and/or coping. Stress communicated by oneself measures how well stress is communicated by oneself to their partner Range 4-20. Stress communicated by one's partner Measures how well one's partner communicates about their stress. Range 4-20. Supportive coping provided by one's partner Measures the quality of emotional and/or problem-focused support provided by one's partner Range 5-25. Negative dyadic coping by one's partner Measures the degree that one's partner uses hostile, ambivalent, and superficial actions/words that have deleterious intentions. Range 4-20. Joint or common coping Measures the degree to which dyads work together to manage stress.Range 5-25. Evaluation of dyadic coping Measures perception of the quality of the dyad's approach to coping.Range 2-10.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
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|---|---|
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Mean Change in Dyadic Coping Inventory Sub Scales
Survivors stress communicated by oneself
|
0 change in units on a scale
Interval -3.5 to 3.5
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Caregivers stress communicated by oneself
|
2.6 change in units on a scale
Interval 0.0 to 5.2
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Survivors stress communicated by partner
|
1.9 change in units on a scale
Interval -1.2 to 4.9
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Caregivers stress communicated by partner
|
0.8 change in units on a scale
Interval -1.6 to 3.3
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Caregivers supportive coping provided by partner
|
1.9 change in units on a scale
Interval -3.9 to 7.6
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Survivors negative dyadic coping by partner
|
2.2 change in units on a scale
Interval 0.2 to 4.1
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Caregivers negative dyadic coping by partner
|
1.8 change in units on a scale
Interval -2.5 to 6.2
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Survivors common dyadic coping
|
1 change in units on a scale
Interval -4.0 to 6.0
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Caregivers common dyadic coping
|
0.9 change in units on a scale
Interval -2.5 to 4.2
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Survivors evaluation of dyadic coping
|
0.9 change in units on a scale
Interval -3.1 to 7.4
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Caregivers evaluation of dyadic coping
|
0.4 change in units on a scale
Interval -1.9 to 2.7
|
|
Mean Change in Dyadic Coping Inventory Sub Scales
Survivors supportive coping provided by partner
|
2.2 change in units on a scale
Interval -3.1 to 7.4
|
SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: 7 survivors 7 caregivers
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.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
|
|---|---|
|
Mean Change in Applied Mindfulness Scale Total Score.
Survivors
|
-2.5 change in units on a scale
Interval -11.9 to 7.1
|
|
Mean Change in Applied Mindfulness Scale Total Score.
Caregivers
|
2.7 change in units on a scale
Interval -3.7 to 9.2
|
SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: 7 survivors 7 caregivers
For caregivers, this scale measures caregiver preparedness to care for survivor. In this study, for survivor participants, we adapted the language to measure preparedness to care for oneself. Scores range from 0 to 32 Higher scores indicate greater perceived readiness for caregiving (for caregivers) or for survivorship (for survivors).
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
|
|---|---|
|
Mean Change in Preparedness for Caregiving Scale Total Score
Survivors
|
5.4 change in units on a scale
Interval -1.6 to 12.0
|
|
Mean Change in Preparedness for Caregiving Scale Total Score
Caregivers
|
3.1 change in units on a scale
Interval -3.5 to 9.7
|
SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: 7 survivors 7 caregivers
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). Both presence of meaning and search for meaning subscale scores range from 5-35. Higher scores indicate greater presence and search.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
|
|---|---|
|
Mean Change in Meaning in Life Questionnaire Sub Scales
Survivors presence
|
-2.2 change in units on a scale
Interval -5.6 to 1.1
|
|
Mean Change in Meaning in Life Questionnaire Sub Scales
Caregivers presence
|
0.2 change in units on a scale
Interval -3.2 to 3.4
|
|
Mean Change in Meaning in Life Questionnaire Sub Scales
Survivors search
|
-5 change in units on a scale
Interval -13.9 to 4.0
|
|
Mean Change in Meaning in Life Questionnaire Sub Scales
Caregivers search
|
0.5 change in units on a scale
Interval -2.4 to 3.5
|
SECONDARY outcome
Timeframe: Pre-test (0 weeks), Post-Test (6 weeks)Population: 7 survivors 7 caregivers
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.
Outcome measures
| Measure |
Intervention
n=14 Participants
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.
Recovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.
|
|---|---|
|
Gratitude Questionnaire Six Item Form
Survivors
|
-0.9 change in units on a scale
Interval -2.6 to 0.9
|
|
Gratitude Questionnaire Six Item Form
Caregivers
|
0 change in units on a scale
Interval -3.7 to 3.7
|
Adverse Events
Intervention: Survivors
Intervention: Caregivers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal investigator
Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place