Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers

Open Pilot Trial of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06517394

Enrollment

Registered

2024-07-24

Start date

2024-08-01

Completion date

2025-04-16

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Emotional Distress

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.

Interventions

BEHAVIORALRecovering 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled	0 weeks	Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.
Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.	Pre-test (0 weeks) to post-test (6 weeks)	Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.
Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.	Pre-test (0 weeks) to post-test (6 weeks)	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.
Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.	Pre-test (0 weeks) to post-test (6 weeks)	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.
Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).	Post-test (6 weeks)	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.
Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire	Pre-test (0 weeks)	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.

Secondary

Measure	Time frame	Description
Mean Change in Dyadic Relationship Scale Sub Scales	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.
Mean Change in Dyadic Coping Inventory Sub Scales	Pre-test (0 weeks), Post-Test (6 weeks)	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.
Mean Change in Applied Mindfulness Scale Total Score.	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.
Mean Change in the Hospital Depression and Anxiety Scale Total Score.	Pre-test (0 weeks), Post-Test (6 weeks)	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.
Mean Change in Meaning in Life Questionnaire Sub Scales	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). Both presence of meaning and search for meaning subscale scores range from 5-35. Higher scores indicate greater presence and search.
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.
Mean Change in Preparedness for Caregiving Scale Total Score	Pre-test (0 weeks), Post-Test (6 weeks)	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).
Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.	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. A negative change in the total score represents improvement in symptoms.
Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score	Pre-test (0 weeks), Post-Test (6 weeks)	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.
Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score	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. A positive mean change in the total score indicates increases in perceived social support.
Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.	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 are averaged and range from 0-4. A positive change in the MOCS-A average score indicates improvements in coping.
Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores	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. Scores were assessed at pre- and post-test; a positive mean change score in each domain indicates improved quality f life.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	14
Total	14

Baseline characteristics

Characteristic	Intervention
Age, Categorical Caregivers <=18 years	0 Participants
Age, Categorical Caregivers >=65 years	3 Participants
Age, Categorical Caregivers Between 18 and 65 years	4 Participants
Age, Categorical Survivors <=18 years	0 Participants
Age, Categorical Survivors >=65 years	4 Participants
Age, Categorical Survivors Between 18 and 65 years	3 Participants
Ethnicity (NIH/OMB) Caregivers Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino	7 Participants
Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported	0 Participants
Ethnicity (NIH/OMB) Survivors Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Survivors Not Hispanic or Latino	7 Participants
Ethnicity (NIH/OMB) Survivors Unknown or Not Reported	0 Participants
Marital Status Caregivers	5 Participants
Marital Status Survivors	5 Participants
Race (NIH/OMB) Caregivers American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Caregivers Asian	0 Participants
Race (NIH/OMB) Caregivers Black or African American	0 Participants
Race (NIH/OMB) Caregivers More than one race	0 Participants
Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Caregivers Unknown or Not Reported	0 Participants
Race (NIH/OMB) Caregivers White	7 Participants
Race (NIH/OMB) Survivors American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Survivors Asian	0 Participants
Race (NIH/OMB) Survivors Black or African American	0 Participants
Race (NIH/OMB) Survivors More than one race	0 Participants
Race (NIH/OMB) Survivors Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Survivors Unknown or Not Reported	0 Participants
Race (NIH/OMB) Survivors White	7 Participants
Sex: Female, Male Caregivers Female	4 Participants
Sex: Female, Male Caregivers Male	3 Participants
Sex: Female, Male Survivors Female	4 Participants
Sex: Female, Male Survivors Male	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 7	0 / 7
other Total, other adverse events	0 / 7	0 / 7
serious Total, serious adverse events	0 / 7	0 / 7

Outcome results

Primary

Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.

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.

Time frame: 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).

Arm	Measure	Value (COUNT_OF_UNITS)
Intervention	Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.	7 dyads

Primary

Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.

Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Intervention	Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.	Survivors	7 Participants
Intervention	Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.	Caregivers	7 Participants

Primary

Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire

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.

Time frame: Pre-test (0 weeks)

Population: For credibility and expectancy, we analyzed individual participant responses on each sub scale (Credibility and expectancy).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Intervention	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	7 Participants
Intervention	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	4 Participants
Intervention	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	6 Participants
Intervention	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	1 Participants

Primary

Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).

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.

Time frame: Post-test (6 weeks)

Population: Analysis population was number of participants that scores above the midpoint on the CSQ-3, not dyads.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Intervention	Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).	14 Participants

Primary

Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled

Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.

Time frame: 0 weeks

Population: Analysis population (unit) was the dyad. We analyzed 8 dyads (8 survivors and 8 caregivers or 16 participants total).

Arm	Measure	Value (COUNT_OF_UNITS)
Intervention	Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled	7 dyads

Primary

Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.

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.

Time frame: 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).

Arm	Measure	Value (COUNT_OF_UNITS)
Intervention	Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.	7 Sessions

Secondary

Gratitude Questionnaire Six Item Form

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.