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

September 7, 2021 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients, 18 years or older
  • English fluency and literacy
  • Access to high speed internet for video sessions
  • Patient with an informal cg (family or friend who provides unpaid care) available and willing to participate
  • Hospitalized with an acute brain injury within 1-2 days when first approached, OR the primary caregiver of a patient currently admitted with an acute brain injury
  • Either patient or caregiver within the dyads screens in for depression, anxiety, and/or PTSD

Exclusion Criteria:

  • Permanent or severe cognitive impairment severe enough to impede participation - This will be determined by nurses through an assessment conducted as part of usual care (MMSE).
  • Dyads where the patient is anticipated to die or to never be able to participate due to medical sequelae.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Recovering Together
Dyads who are randomly assigned to the Recovering Together program will receive any usual clinic care as determined by their clinicians. Additionally, dyads will be invited to participate in 6 30-minute skills sessions. All sessions will include both pt and cg. A clinical psychologist will deliver the majority of sessions while the PI will deliver at least 10% of the sessions. The main intervention goal is to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS.
Behavioral: Recovering Together
The 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
NO_INTERVENTION: Health Education
Patients randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of recruitment (ability to recruit dyads)
Time Frame: Baseline
Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Baseline
Feasibility of intervention delivery (ability to deliver intervention to dyads)
Time Frame: Feasibility of program delivery will be measured at 6 weeks
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Feasibility of program delivery will be measured at 6 weeks
Credibility and expectancy questionnaire
Time Frame: Baseline
This measure will assess participants' belief that the intervention (or control) will be helpful.
Baseline
Client Satisfaction Questionnaire
Time Frame: post intervention (6 weeks after baseline)
This measure will assess participants' satisfaction with participation in the study.
post intervention (6 weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale
Time Frame: baseline to posttest to 3 months follow up
Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.
baseline to posttest to 3 months follow up
Post Traumatic Checklist
Time Frame: baseline to posttest to 3 months follow up
Measures symptoms of post traumatic stress and determines diagnoses
baseline to posttest to 3 months follow up
Measures of Coping Style part A
Time Frame: baseline to posttest to 3 months follow up
measures various coping strategies such as relaxation or adaptive thinking
baseline to posttest to 3 months follow up
Cognitive and Affective Mindfulness Scale revised
Time Frame: baseline to post test to 3 months follow up
Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness.
baseline to post test to 3 months follow up
Self-efficacy scale
Time Frame: baseline to post test to 3 months follow up
Measures beliefs in own ability to manage stress and daily life situations. The scale has 10 items and ranges from 10 to 40, with higher scores indicating higher self efficacy.
baseline to post test to 3 months follow up
Intimade bond measure
Time Frame: baseline to post test to 3 months follow up
measures care and intimacy between the 2 members of the dyad. The scale has 24 items and ranges from 0 to 71 with higher scores indicating more intimate and caring relationship between the dyad members
baseline to post test to 3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

October 11, 2020

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (ACTUAL)

October 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P002187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Brain Injuries

Clinical Trials on Recovering Together

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe