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The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.
The goals of this study are to: 1) demonstrate the efficacy of Recovering Together for improving self-reported emotional distress (primary outcome), and post traumatic stress, mindfulness, coping, social support and other relevant outcomes (secondary outcomes); and 2) assess mechanisms (mediators and moderators) of improvement after intervention. We will enroll and randomly assign 194 at risk dyads (97 per study group) to receive either the active intervention or educational control. The trial is single blinded (assessors, patients and staff). The trial will take place at the Massachusetts General Hospital NICU using our established methodology successfully implemented during the R21 pilot study. Study clinicians will deliver 6, 30 minute sessions of active intervention or educational control (2 at bedside and 4 via live video after discharge) to each patient-caregiver dyad. All participants will complete measures at baseline, after completion of program (6 weeks) and 3 months later. They will also complete measures of emotional distress weekly, as well as measures assessing home practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Patient-Caregiver Dyads | Experimental | There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily skills. |
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| Control Patient-Caregiver Dyads | Active Comparator | There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily educational. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recovering Together | Behavioral | In the skills-based intervention group, sessions focus on developing skills to cope and manage ANI related stressors. The intervention will be tailored consistent with AHA recommendations for ANI skills-based interventions and will include 2 general and 4 specific modules. It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered, in person if possible, within the NICU, or through live video using Zoom if patients leave the hospital before sessions occur, and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Emotional Distress | Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression | 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Post-Traumatic Stress | Post-Traumatic Stress Disorder Checklist - Specific Event (PCL-S); 17-85, higher scores indicate greater post-traumatic stress | 0 weeks, 6 weeks, 3 months |
| Change in Resiliency Factors (Mindfulness - curiosity and de-centering) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Factors (potential moderators) | Age; biological sex; gender; race/ethnicity; educational level; employment status; occupation; income; marital status; prior ANI status; mental health history; psychotropic medications; medical comorbidities; satisfaction with medical staff (analog scale 0-10) | 0 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36368480 | Derived | Vranceanu AM, Woodworth EC, Kanaya MR, Bannon S, Mace RA, Manglani H, Duarte BA, Rush CL, Choukas NR, Briskin EA, Cohen J, Parker R, Macklin E, Lester E, Traeger L, Rosand J; Neuro-ICU Recovering Together Team; Grunberg VA. The Recovering Together study protocol: A single-blind RCT to prevent chronic emotional distress in patient-cargiver dyads in the Neuro-ICU. Contemp Clin Trials. 2022 Dec;123:106998. doi: 10.1016/j.cct.2022.106998. Epub 2022 Nov 8. |
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| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| Recovering Together | Behavioral | Those in the educational program will receive general health information that mimics the skills-based intervention, but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. There will also be 6 sessions, 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits following discharge. The educational program group will not have the opportunity to specify which modules they would like to take; the modules will be predetermined. All participants will receive medical care as determined by their medical team. |
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Toronto Mindfulness Scale-Trait (TMS-Trait); 0-52, higher scores indicate greater perceived mindfulness (specifically curiosity and de-centering) |
| 0 weeks, 6 weeks, 3 months |
| Change in Resiliency Factors (Mindfulness) | Cognitive and Affective Mindfulness Scale (CAMS); 12-48, higher scores indicate greater perceived mindfulness | 0 weeks, 6 weeks, 3 months |
| Change in Resiliency Factors (Individual Coping) | Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope | 0 weeks, 6 weeks, 3 months |
| Change in Resiliency Factors (Dyadic Coping) | Dyadic Coping Inventory (DCI); 35-175; higher scores indicate greater perceived coping in the context of a relationship | 0 weeks, 6 weeks, 3 months |
| Change in Interpersonal Factors (perceived social support) | Interpersonal Support Evaluation List-12 (ISEL-12); 0-48, higher scores indicate greater perceived social support | 0 weeks, 6 weeks, 3 months |
| Change in Interpersonal Factors (avoidant or anxious communication) | Experiences in Close Relationships Scale short form (ECR-S); 7-42, higher scores indicate greater avoidant or anxious communication | 0 weeks, 6 weeks, 3 months |
| Change in Interpersonal Factors (dyadic strain and positive interpersonal interactions) | Dyadic Relationship Scale (DRS); Patient version: 10-40, caregiver version: 11-44, dyadic strain subscale: higher scores indicate greater levels of strain, positive dyadic interaction subscale: higher scores indicate greater levels of positive interaction | 0 weeks, 6 weeks, 3 months |
| Change in Independence in activities of daily living (potential moderator) |
Barthel Score; 0-100, higher scores indicate greater independence |
| 0 weeks, 6 weeks, 3 months |
| Change in Degree of disability or dependence (potential moderator) | Modified Rankin; 0-6, higher scores indicate greater disability | 0 weeks, 6 weeks, 3 months |