Emotional DistressRT-CANCT07143357
Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest
A study testing Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 in people with Emotional Distress and Cardiac Arrest (CA), run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Distress, Cardiac Arrest (CA), Anxiety
- What is being tested?
- Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Oct 2025to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- survivor must score >5 on Short Form of the Mini Mental State Exam for sufficient cognitive function for meaningful participation
- ability and willingness to participate in a hybrid in-person/live video intervention
- English speaking adults (18 year or older)
- 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).
Who cannot join
- active psychosis, mania, substance dependence, or suicidal intent or plan that would require a higher level of care
- any other psychiatric or neurological condition that would preclude meaningful participation
- the caregiver must not be a cardiac arrest survivor
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Mount Sinai Health System
New York, New York, 10029
About this study
Official title: Development of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest (RT-CA).
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.
Read the detailed description
The goal of this study is to test the feasibility of the 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 takes place initially in intensive care units and step-down units then progresses to Zoom once survivors are discharged. 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.
- Conditions
- Emotional Distress, Cardiac Arrest (CA), Anxiety, Depression, Caregivers, Survivorship
- Being tested
- Recovering Together after Cardiac Arrest 1, Recovering Together after Cardiac Arrest 2
- Keywords
- emotional distress, cardiac arrest, cardiac arrest survivorship, caregivers, resilience, mindfulness, mind-body, behavioral interventions, anxiety, depression
- Medical subject headings
- Heart Arrest, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovering Together after Cardiac Arrest 1Behavioural
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.
Recovering Together after Cardiac Arrest 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Recovering Together after Cardiac Arrest 1 | Experimental | Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance 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. Receives: Behavioral: Recovering Together after Cardiac Arrest 1 |
| Recovering Together after Cardiac Arrest 2 | Other | Recovering Together after Cardiac Arrest is a minimally enhanced usual care control. Dyads will participate in one 30-minute session with a clinician reviewing available psychosocial resources for cardiac arrest survivors and their caregivers. Receives: Other: Recovering Together after Cardiac Arrest 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment
Proportion of eligible dyads that consent to participation
Measured: pre-test
Feasibility of Randomization
Proportion of randomized participants who submit post-test assessments
Measured: The end of treatment at 6 weeks
Feasibility of Assessment Completion
Proportion of participants with no assessment measures missing at pre-test, post-test, and 3 month follow-up
Measured: pre-test, the end of treatment at 6 weeks, and 3 months after the end of treatment
Feasibility of Program Adherence (RT-CA 1)
Proportion of RT-CA 1 dyads that initiate the program by attending session 1 and complete at least 4 of 6 sessions.
Measured: the end of treatment at 6 weeks
Therapist Fidelity
Proportion of 20% randomly-selected RT-CA 1 sessions in which the therapist fully adheres to program content, ascertained by a fidelity checklist
Measured: the end of treatment at 6 weeks
Treatment Satisfaction (RT-CA 1)
Proportion of RT-CA 1 participants that endorse satisfaction, defined as above the midpoint on the Client Satisfaction Questionnaire-3
Measured: the end of treatment at 6 weeks
Credibility (RT-CA 1)
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 which is scored from 3-27; higher scores indicate greater credibility.
Measured: pre-test
Expectancy (RT-CA 1)
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 which is scored from 3-27; higher scores indicate greater expectancy.
Measured: pre-test
Study safety
The proportion of participants that report no adverse events related to study participation.
Measured: at the end of treatment at 6 weeks and 3 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start17 Oct 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Alexander Presciutti, Icahn School of Medicine at Mount Sinai
- Investigators
- Alexander Presciutti, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143357
- Sponsor's protocol ID
- STUDY-26-00513
- Other IDs
- 5K23AT012487, 2025P002063
- Acronym
- RT-CA
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon reasonable request.