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

NCT03694678 | Completed Results

• 1 other identifier: 2018P002187
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Brain Injuries

Keywords

Psychiatry; Dyads; Patients; Caregivers; Psychosocial

Outcome Measures

Primary Outcomes (4)

• Feasibility of Recruitment (Ability to Recruit Dyads)

  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)

  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

  This measure will assess participants' belief that the intervention (or control) will be helpful. The score range is 3-27. Higher scores mean higher perception of credibility or expectancy.

  Baseline

• Client Satisfaction Questionnaire

  This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.

  post intervention (6 weeks after baseline)

Secondary Outcomes (5)

• Hospital Anxiety and Depression Scale

  baseline to posttest to 3 months follow up

• Post Traumatic Checklist

  baseline to posttest to 3 months follow up

• Measures of Coping Style Part A

  baseline to posttest to 3 months follow up

• Cognitive and Affective Mindfulness Scale Revised

  baseline to post test to 3 months follow up

• Dyadic Relationship Scale

  Baseline, post treatment, 3-month follow-up

Study Arms (2)

Recovering Together

EXPERIMENTAL

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

Health Education

NO INTERVENTION

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.

Interventions

Recovering Together BEHAVIORAL

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

Recovering Together

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Brasil S, de Carvalho Nogueira R, Salinet ASM, Yoshikawa MH, Teixeira MJ, Paiva W, Malbouisson LMS, Bor-Seng-Shu E, Panerai RB. Critical Closing Pressure and Cerebrovascular Resistance Responses to Intracranial Pressure Variations in Neurocritical Patients. Neurocrit Care. 2023 Oct;39(2):399-410. doi: 10.1007/s12028-023-01691-8. Epub 2023 Mar 3.

  PMID: 36869208 DERIVED

• Bannon SM, Cornelius T, Gates MV, Lester E, Mace RA, Popok P, Macklin EA, Rosand J, Vranceanu AM. Emotional distress in neuro-ICU survivor-caregiver dyads: The recovering together randomized clinical trial. Health Psychol. 2022 Apr;41(4):268-277. doi: 10.1037/hea0001102. Epub 2021 Sep 9.

  PMID: 34498896 DERIVED

• Vranceanu AM, Bannon S, Mace R, Lester E, Meyers E, Gates M, Popok P, Lin A, Salgueiro D, Tehan T, Macklin E, Rosand J. Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020807. doi: 10.1001/jamanetworkopen.2020.20807.

  PMID: 33052404 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Ana-Maria Vranceanu
• Organization: Massachusetts General Hospital

avranceanu@mgh.harvard.edu

6178931664

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Integrated Brain Health Clinical and Research Program

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 3, 2018
• Study Start: January 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 11, 2020
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)