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

Abstract

Importance: To our knowledge, there are no evidence-based interventions to prevent chronic emotional distress (ie, depression, anxiety, and posttraumatic stress [PTS]) in critical care survivors and their informal caregivers.

Objective: To determine the feasibility and preliminary effect of the novel dyadic resiliency intervention Recovering Together (RT) on reducing symptoms of depression, anxiety, and PTS among hospitalized patients and their informal caregivers.

Design, setting, and participants: This single-blind, pilot randomized clinical trial of RT vs an educational control was conducted among 58 dyads in which either the survivor or caregiver endorsed clinically significant symptoms of depression, anxiety, or PTS. The study was conducted in the neuroscience intensive care unit at Massachusetts General Hospital. Data were collected from September 2019 to March 2020.

Interventions: Both RT and control programs had 6 sessions (2 at bedside and 4 via live video after discharge), and both survivor and caregiver participated together.

Main outcomes and measures: The primary outcomes were feasibility of recruitment and intervention delivery, credibility, and satisfaction. The secondary outcomes included depression and anxiety (measured by the Hospital Depression and Anxiety Scale), PTS (measured by the PTSD Checklist-Civilian Version), and intervention targets (ie, mindfulness, measured by the Cognitive and Affective Mindfulness Scale-Revised; coping, measured by the Measure of Current Status-Part A; and dyadic interpersonal interactions, measured by the Dyadic Relationship Scale). Main outcomes and targets were assessed at baseline, 6 weeks, and 12 weeks.

Results: The 58 dyads were randomized to RT (29 dyads [50.0%]; survivors: mean [SD] age, 49.3 [16.7] years; 9 [31.0%] women; caregivers: mean [SD] age, 52.4 [14.3] years; 22 [75.9%] women) or control (29 dyads [50.0%]; survivors: mean [SD] age, 50.3 [16.4] years; 12 [41.3%] women; caregivers, mean [SD] age, 52.1 [14.9], 17 [58.6%] women). Feasibility (recruitment [76%], randomization [100%], and data collection [83%-100%]), adherence (86%), fidelity (100%; κ = 0.98), satisfaction (RT: 57 of 58 [98%] with scores >6; control: 58 of 58 [100%] with scores >6), credibility (RT: 47 of 58 [81%] with scores >6; control: 46 of 58 [80%] with scores >6), and expectancy (RT: 49 of 58 [85%] with scores >13.5; 51 of 58 [87%] with scores >13.5) exceeded benchmarks set a priori. Participation in RT was associated with statistically and clinically significant improvement between baseline and postintervention in symptoms of depression (among survivors: -4.0 vs -0.6; difference, -3.4; 95% CI, -5.6 to -1.3; P = .002; among caregivers: -3.8 vs 0.6; difference, -4.5; 95% CI, -6.7 to -2.3; P < .001), anxiety (among survivors: -6.0 vs 0.3; difference, -6.3; 95% CI, -8.8 to -3.8; P < .001; among caregivers: -5.0 vs -0.9; difference, -4.1; 95% CI, -6.7 to -1.5, P = .002), and PTS (among survivors: -11.3 vs 1.0; difference, -12.3; 95% CI, -18.1 to -6.5, P < .001; among caregivers, -11.4 vs 5.0; difference, -16.4, 95% CI, -21.8 to -10.9; P < .001). Improvements sustained through the 12-week follow-up visit. We also observed RT-dependent improvement in dyadic interpersonal interactions for survivors (0.2 vs -0.2; difference, 0.4; 95% CI, 0.0 to 0.8; P = .04).

Conclusions and relevance: In this pilot randomized clinical trial, RT was feasible and potentially efficacious in preventing chronic emotional distress in dyads of survivors of the neuroscience intensive care unit and their informal caregivers.

Trial registration: ClinicalTrials.gov Identifier: NCT03694678.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Vranceanu reported receiving funding from the Department of Defense and the National Institutes of Health and serving on the scientific advisory board for the Calm application outside of the submitted work. Dr Macklin reported serving on the scientific advisory boards of Biogen and Cerevance, serving on the data safety monitoring boards of Novartis and Shire, and receiving grants from Amylyx, GlaxoSmithKline, and Mitsubishi Tanabe outside the submitted work. Dr Rosand reported receiving grants from the National Institutes of Health and serving as a consultant for Boehringer Ingelheim, Pfizer, and New Beta Innovation outside the submitted work. No other disclosures were reported.

Figures

Figure.. Study Flowchart

HADS indicates Hospital Anxiety and Depression Scale; and PCL, PTSD Checklist–Civilian Version.