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

Not Applicable
Completed
Conditions
Acute Brain Injuries
Registration Number
NCT03694678
Lead Sponsor
Massachusetts General Hospital
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
126
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)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

Credibility and Expectancy QuestionnaireBaseline

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.

Client Satisfaction Questionnairepost 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.

Feasibility of Recruitment (Ability to Recruit Dyads)Baseline

Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled

Secondary Outcome Measures
NameTimeMethod
Dyadic Relationship ScaleBaseline, 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.

Hospital Anxiety and Depression Scalebaseline 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.

Post Traumatic Checklistbaseline 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.

Measures of Coping Style Part Abaseline 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.

Cognitive and Affective Mindfulness Scale Revisedbaseline 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.

Trial Locations

Locations (1)

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States

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