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 range18 Years

SexALL

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)

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 range18 Years

SexALL

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)