Clinical Trials Directory

Trials / Completed

CompletedNCT03694678

Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers

Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
126 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The investigators will compare a dyadic intervention (Recovering Together) with an attention placebo educational control in dyads of patients with acute neurological illnesses and their caregivers at risk for chronic emotional distress. The primary aim of this study is to determine the feasibility, credibility, and satisfaction with Recovering Together. The second aim is to show proof of concept for sustained improvement in emotional distress, post traumatic stress (PTS), resiliency and interpersonal communication outcomes in patients and caregivers.

Detailed description

The investigators aim to improve the care of patients (pts) admitted to the Neuroscience Intensive Care Unit (NICU) and their family caregivers (cgs) by conducting a pilot feasibility randomized controlled trial (RCT; N=80 dyads; 60 completers) of the dyadic resiliency program ("Recovering Together") to prevent chronic emotional distress in both pts and their cgs. Eligible dyads include adult, English speaking pts with acute neurological injury (ANI) admitted to the NICU, cleared medically and cognitively for participation by the nursing team, and their primary cgs. Dyads who are randomly assigned to "Recovering Together" will receive 6 manualized sessions (2 in person at hospitalization and 4 through live video after discharge, to reduce burden and facilitate access to care) led by a clinical psychologist. Dyads who are randomly assigned to the attention placebo educational control condition will receive 6 manualized sessions (2 in person and 4 through live video with a clinical psychologist), modeled after the Recovering Together program that will control for the dose of the intervention and support from therapist. Dyads will complete assessment surveys before, after the intervention and 3 months later. Clinical data on demographics, diagnosis, ANI severity, and any medical complications will be extracted from electronic health records.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRecovering TogetherThe intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver will participate in all sessions

Timeline

Start date
2019-01-01
Primary completion
2020-10-01
Completion
2020-10-11
First posted
2018-10-03
Last updated
2025-05-28
Results posted
2025-05-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03694678. Inclusion in this directory is not an endorsement.