N/A
N=122
Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers
Acute Brain Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03694678 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Feasibility of Recruitment (Ability to Recruit Dyads) — 122; 40; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Recovering Together (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruitment (Ability to Recruit Dyads) |
122; 40; 4 | — |
| PRIMARY Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads) |
29; 31; 1; 0 | — |
| PRIMARY Credibility and Expectancy Questionnaire |
22.0; 20.3; 19.0; 19.5 | — |
| PRIMARY Client Satisfaction Questionnaire |
10.65; 9.87 | — |
| SECONDARY Hospital Anxiety and Depression Scale |
8.7; 7.8; 7.1; 4.8; 4.0; 3.28 | — |
| SECONDARY Post Traumatic Checklist |
41.6; 43.2; 29.3; 29.4; 26.4; 39.3 | — |
| SECONDARY Measures of Coping Style Part A |
2.2; 2.3; 2.6; 2.5; 2.7; 2.6 | — |
| SECONDARY Cognitive and Affective Mindfulness Scale Revised |
34.2; 34.6; 35.1; 36.4; 36.7; 36.3 | — |
| SECONDARY Dyadic Relationship Scale |
2.0; 2.0; 2.0; 1.8; 1.6; 2.01 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03694678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.