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

NCT05157880 | Recruiting DMC

• 1 other identifier: 2021P001943
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Neurological Injury; Emotional Distress

Keywords

Neurological Injury; Emotional Distress; Dyadic Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Emotional Distress

  Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression

  0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months

Secondary Outcomes (8)

• Change in Post-Traumatic Stress

  0 weeks, 6 weeks, 3 months

• Change in Resiliency Factors (Mindfulness - curiosity and de-centering)

  0 weeks, 6 weeks, 3 months

• Change in Resiliency Factors (Mindfulness)

  0 weeks, 6 weeks, 3 months

• Change in Resiliency Factors (Individual Coping)

  0 weeks, 6 weeks, 3 months

• Change in Resiliency Factors (Dyadic Coping)

  0 weeks, 6 weeks, 3 months

Other Outcomes (3)

• Demographic Factors (potential moderators)

  0 weeks

• Change in Independence in activities of daily living (potential moderator)

  0 weeks, 6 weeks, 3 months

• Change in Degree of disability or dependence (potential moderator)

  0 weeks, 6 weeks, 3 months

Study Arms (2)

Experimental Patient-Caregiver Dyads

EXPERIMENTAL

There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily skills.

Behavioral: Recovering Together

Control Patient-Caregiver Dyads

ACTIVE COMPARATOR

There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily educational.

Behavioral: Recovering Together

Interventions

Recovering Together BEHAVIORAL

In the skills-based intervention group, sessions focus on developing skills to cope and manage ANI related stressors. The intervention will be tailored consistent with AHA recommendations for ANI skills-based interventions and will include 2 general and 4 specific modules. It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered, in person if possible, within the NICU, or through live video using Zoom if patients leave the hospital before sessions occur, and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom.

Also known as: Skills-based intervention

Experimental Patient-Caregiver Dyads

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

• Vranceanu AM, Woodworth EC, Kanaya MR, Bannon S, Mace RA, Manglani H, Duarte BA, Rush CL, Choukas NR, Briskin EA, Cohen J, Parker R, Macklin E, Lester E, Traeger L, Rosand J; Neuro-ICU Recovering Together Team; Grunberg VA. The Recovering Together study protocol: A single-blind RCT to prevent chronic emotional distress in patient-cargiver dyads in the Neuro-ICU. Contemp Clin Trials. 2022 Dec;123:106998. doi: 10.1016/j.cct.2022.106998. Epub 2022 Nov 8.

  PMID: 36368480 DERIVED

MeSH Terms

Conditions

Trauma, Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries

Central Study Contacts

Ana-Maria Vranceanu, PhD

CONTACT

617-724-4977; avranceanu@mgh.harvard.edu

Emily Woodworth, BA

CONTACT

617-643-4123; ewoodworth@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Director

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 15, 2021
• Study Start: December 10, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)