Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers
- Conditions
- Acute Neurological InjuryEmotional Distress
- Interventions
- Behavioral: Recovering Together
- Registration Number
- NCT05157880
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 388
- Age 18 or older
- English fluency and literacy
- Patient with an informal caregiver available and willing to participate
- Hospitalized with any ANI within 6 weeks (patient) OR informal caregiver of a patient currently admitted with any ANI
- Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores > 7)
- Permanent cognitive impairment (including severe hearing impairment) or aphasia that makes participation impossible
- Short form of Mini-Mental State Exam (SMMSE) score <4 (If SMMSE <4, nursing team decides whether or not the patient can meaningfully participate)
- Glasgow Coma Scale (GCS) score <10
- Terminal diagnosis
- Lack of access to internet and/or a device with a camera
- Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Patient-Caregiver Dyads Recovering Together 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. Experimental Patient-Caregiver Dyads Recovering Together 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.
- Primary Outcome Measures
Name Time Method Change in Emotional Distress 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression
- Secondary Outcome Measures
Name Time Method Change in Post-Traumatic Stress 0 weeks, 6 weeks, 3 months Post-Traumatic Stress Disorder Checklist - Specific Event (PCL-S); 17-85, higher scores indicate greater post-traumatic stress
Change in Interpersonal Factors (perceived social support) 0 weeks, 6 weeks, 3 months Interpersonal Support Evaluation List-12 (ISEL-12); 0-48, higher scores indicate greater perceived social support
Change in Resiliency Factors (Mindfulness - curiosity and de-centering) 0 weeks, 6 weeks, 3 months Toronto Mindfulness Scale-Trait (TMS-Trait); 0-52, higher scores indicate greater perceived mindfulness (specifically curiosity and de-centering)
Change in Resiliency Factors (Mindfulness) 0 weeks, 6 weeks, 3 months Cognitive and Affective Mindfulness Scale (CAMS); 12-48, higher scores indicate greater perceived mindfulness
Change in Resiliency Factors (Individual Coping) 0 weeks, 6 weeks, 3 months Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
Change in Resiliency Factors (Dyadic Coping) 0 weeks, 6 weeks, 3 months Dyadic Coping Inventory (DCI); 35-175; higher scores indicate greater perceived coping in the context of a relationship
Change in Interpersonal Factors (avoidant or anxious communication) 0 weeks, 6 weeks, 3 months Experiences in Close Relationships Scale short form (ECR-S); 7-42, higher scores indicate greater avoidant or anxious communication
Change in Interpersonal Factors (dyadic strain and positive interpersonal interactions) 0 weeks, 6 weeks, 3 months 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
Trial Locations
- Locations (1)
Massachusetts General Hospital (MGH)
🇺🇸Boston, Massachusetts, United States