RECRUITING

Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-12-10
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05157880

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * English fluency and literacy
  3. * Patient with an informal caregiver available and willing to participate
  4. * Hospitalized with any ANI within 6 weeks (patient) OR informal caregiver of a patient currently admitted with any ANI
  5. * Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores \> 7)
  1. * Permanent cognitive impairment (including severe hearing impairment) or aphasia that makes participation impossible
  2. * Short form of Mini-Mental State Exam (SMMSE) score \<4 (If SMMSE \<4, nursing team decides whether or not the patient can meaningfully participate)
  3. * Glasgow Coma Scale (GCS) score \<10
  4. * Terminal diagnosis
  5. * Lack of access to internet and/or a device with a camera
  6. * Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

Contacts and Locations

Study Contact

Ana-Maria Vranceanu, PhD
CONTACT
617-724-4977
avranceanu@mgh.harvard.edu
Emily Woodworth, BA
CONTACT
617-643-4123
ewoodworth@mgb.org

Study Locations (Sites)

Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-10
Study Completion Date2026-03

Study Record Updates

Study Start Date2021-12-10
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Neurological Injury
  • Emotional Distress
  • Dyadic Intervention

Additional Relevant MeSH Terms

  • Acute Neurological Injury
  • Emotional Distress