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Completed

NCT Number: NCT03694678

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. Credibility and Expectancy Questionnaire

    Time frame: Baseline

    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.

  4. Client Satisfaction Questionnaire

    Time frame: post intervention (6 weeks after baseline)

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

Secondary outcomes

  1. 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.

  2. Post Traumatic Checklist

    Time frame: baseline to posttest to 3 months follow up

    The PTSD CheckList - Civilian Version measures symptoms of post traumatic stress and determines diagnoses. Scores range from 17-85. Higher scores indicate more severe stress.

  3. Measures of Coping Style Part A

    Time frame: baseline to posttest to 3 months follow up

    The MOCS-A measures various coping strategies such as relaxation or adaptive thinking. Scores range from 0 to 52, and higher scores indicate greater self-perceived proficiency with these skills.

  4. 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.

  5. Dyadic Relationship Scale

    Time frame: Baseline, post treatment, 3-month follow-up

    The Dyadic Relationship Scale (DRS) has 2 sub scales that assess dyadic strains and dyadic positive interaction. Scales on each sub scale range from 1 to 4, with higher scores indicating great severity of the relevant construct.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2018
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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