CompletedNot Applicable

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

United States14 participantsStarted 2024-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)
. Score ≥4 on Short Form of the Mini Mental State Exam
. Ability and willingness to participate in a hybrid in-person/live video or phone intervention
. English speaking adults, 18 years or older
. At least one member of the dyad endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression Scale subscales)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled

Timeframe: 0 weeks

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

Timeframe: Pre-test (0 weeks) to post-test (6 weeks)

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

Timeframe: Pre-test (0 weeks) to post-test (6 weeks)

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

Timeframe: Pre-test (0 weeks) to post-test (6 weeks)

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

Timeframe: Post-test (6 weeks)

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

Timeframe: Pre-test (0 weeks)

Trial details

NCT IDNCT06517394

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-09

Results submitted2025-06-20

View on ClinicalTrials.gov More Emotional Distress trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)
. Score ≥4 on Short Form of the Mini Mental State Exam
. Ability and willingness to participate in a hybrid in-person/live video or phone intervention
. English speaking adults, 18 years or older
. At least one member of the dyad endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression Scale subscales)

What they're measuring

Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled

Timeframe: 0 weeks

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

Timeframe: Pre-test (0 weeks) to post-test (6 weeks)

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

Timeframe: Pre-test (0 weeks) to post-test (6 weeks)

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

Timeframe: Pre-test (0 weeks) to post-test (6 weeks)

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

Timeframe: Post-test (6 weeks)

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

Timeframe: Pre-test (0 weeks)