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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AT012487 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
The goal of this study is to test the feasibility of our 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 will initially take place at Massachusetts General Hospital intensive care units and step-down units. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recovering Together after Cardiac Arrest 1 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment | Proportion of eligible dyads that consent to participation | pre-test |
| Feasibility of Randomization | Proportion of randomized participants who submit post-test assessments | 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 | 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. | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Presciutti, PhD | Contact | 617-726-7913 | apresciutti@mgh.harvard.edu | |
| Sara Bogan, BA | Contact | 617-724-1312 | sbogan@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
De-identified data will be shared upon reasonable request.
IPD will be available from trial end through three years after the publication of all study results.
Individuals will be able to access the data after signing a data sharing agreement.
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| Recovering Together after Cardiac Arrest 2 | Other | 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. |
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| 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 | pre-test |
| Study safety | The proportion of participants that report no adverse events related to study participation. | at the end of treatment at 6 weeks and 3 months after the end of treatment |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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