Clinical trial NCT03694678: Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers
Official title: Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Brain Injuries
Keywords: Psychiatry
Dyads
Patients
Caregivers
Psychosocial
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Feasibility of Recruitment (Ability to Recruit Dyads)
timeFrame: Baseline
measure: Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)
timeFrame: Feasibility of program delivery will be measured at 6 weeks
measure: Credibility and Expectancy Questionnaire
timeFrame: Baseline
measure: Client Satisfaction Questionnaire
timeFrame: post intervention (6 weeks after baseline)
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline to posttest to 3 months follow up
measure: Post Traumatic Checklist
timeFrame: baseline to posttest to 3 months follow up
measure: Measures of Coping Style Part A
timeFrame: baseline to posttest to 3 months follow up
measure: Cognitive and Affective Mindfulness Scale Revised
timeFrame: baseline to post test to 3 months follow up
measure: Dyadic Relationship Scale
timeFrame: Baseline, post treatment, 3-month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.