Clinical trial NCT05157880: Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers
Official title: Recovering Together: Building Resiliency in Dyads of Patients With an Acute Brain Injury Admitted to the Neuroscience Intensive Care Unit and Their Informal Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Neurological Injury
Emotional Distress
Keywords: Neurological Injury
Emotional Distress
Dyadic Intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Emotional Distress
timeFrame: 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months
Secondary outcomes:
measure: Change in Post-Traumatic Stress
timeFrame: 0 weeks, 6 weeks, 3 months
measure: Change in Resiliency Factors (Mindfulness - curiosity and de-centering)
timeFrame: 0 weeks, 6 weeks, 3 months
measure: Change in Resiliency Factors (Mindfulness)
timeFrame: 0 weeks, 6 weeks, 3 months
measure: Change in Resiliency Factors (Individual Coping)
timeFrame: 0 weeks, 6 weeks, 3 months
measure: Change in Resiliency Factors (Dyadic Coping)
timeFrame: 0 weeks, 6 weeks, 3 months
measure: Change in Interpersonal Factors (perceived social support)
timeFrame: 0 weeks, 6 weeks, 3 months
measure: Change in Interpersonal Factors (avoidant or anxious communication)
timeFrame: 0 weeks, 6 weeks, 3 months
measure: Change in Interpersonal Factors (dyadic strain and positive interpersonal interactions)
timeFrame: 0 weeks, 6 weeks, 3 months
Other outcomes:
measure: Demographic Factors (potential moderators)
timeFrame: 0 weeks
measure: Change in Independence in activities of daily living (potential moderator)
timeFrame: 0 weeks, 6 weeks, 3 months
measure: Change in Degree of disability or dependence (potential moderator)
timeFrame: 0 weeks, 6 weeks, 3 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
Study officials:
References: