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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
126
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
Massachusetts General Hospital
Boston, Massachusetts, United States
Feasibility of Recruitment (Ability to Recruit Dyads)
Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Time frame: Baseline
Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Time frame: Feasibility of program delivery will be measured at 6 weeks
Credibility and Expectancy Questionnaire
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.
Time frame: Baseline
Client Satisfaction Questionnaire
This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Time frame: post intervention (6 weeks after baseline)
Hospital Anxiety and Depression Scale
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.
Time frame: baseline to posttest to 3 months follow up
Post Traumatic Checklist
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.
Time frame: baseline to posttest to 3 months follow up
Measures of Coping Style Part A
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.
Time frame: baseline to posttest to 3 months follow up
Cognitive and Affective Mindfulness Scale Revised
Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness.
Time frame: baseline to post test to 3 months follow up
Dyadic Relationship Scale
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.
Time frame: Baseline, post treatment, 3-month follow-up
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