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Pilot Trial: Resiliency Intervention Feasible for Survivors of Critical Neurologic Illness, Family Caregivers

Key findings

  • No evidence-based interventions have proved successful in preventing chronic emotional distress in patients who survive critical neurologic illness or in their family caregivers
  • 29 at risk patient–caregiver dyads were assigned to six sessions of a skills training intervention called Recovering Together (RT), and 29 at risk dyads were assigned to six sessions of an educational program that did not provide skills training
  • The feasibility of RT was excellent as evidenced by the ability to recruit participants quickly and retain dyads
  • Both intervention and control were delivered with high fidelity and most participants experienced high satisfaction with RT
  • Symptoms of depression, anxiety and post-traumatic stress improved more in dyads assigned to RT than those assigned to control; improvements were observed for both patients and caregivers, were clinically meaningful and persisted through follow-up

Thanks to advanced treatments and technologies, an increasing number of patients are surviving critical neurologic illness. However, depression, anxiety and post-traumatic stress (PTS) are common and can persist long-term not only for the survivors but also the family and friends who support them.

For the past five years, a multidisciplinary team of psychologists, nurses and neurointensivists at Massachusetts General Hospital has been developing "Recovering Together" (RT), a resiliency intervention aimed at preventing chronic emotional distress in both survivors and their caregivers. As described previously in Pilot and Feasibility Studies, RT teaches self-efficacy, mindfulness, coping skills and increased interpersonal relationships within dyads (pairs of patients with acute brain injury and their caregivers).

RT is the first dyadic—or pairs of patient and caregiver—program for this population. RT draws systematically from mindfulness, dialectical behavioral therapy, cognitive-behavioral, and positive psychology principles.

Now, in a pilot trial, Ana-Maria Vranceanu, PhD, founding director of the Integrated Brain Health Clinical and Research Program and faculty member of the Henry and Allison McCance Center for Brain Health at Mass General, and Jonathan Rosand, MD, co-director of the Henry and Allison McCance Center for Brain Health, and colleagues have shown that recruitment to RT is feasible and the program is potentially efficacious. Their report appears in JAMA Network Open. Co-authors include Tara Tehan, RN, director of the Neuroscience Intensive Care Unit, and Danielle Salgueiro, RN. Additional co-authors include the clinical research team, Ethan Lester, PhD, Sarah Bannon, PhD, Ryan Mace and Emma Meyers.

Study Methods

The single-blind, randomized, controlled trial was conducted in the Mass General Neuroscience ICU from September 2019 to March 2020. Within each dyad, the patient, caregiver or both had clinically significant depression, anxiety or PTS.

29 dyads were randomly assigned to RT and 29 to an educational control. All dyads received manuals labeled as Recovering Together 1 (active intervention) or Recovering Together 2 (educational control). At recruitment, staff installed a web-based application on each participant's smartphone or another device to provide content for the six sessions that would be conducted in person, as well as audio recordings to facilitate practice.

The first two sessions of RT were conducted in the ICU and taught concrete skills for coping with the trauma of hospitalization and the need for self-care. The subsequent four sessions were selected from a total of 6 available, based on the needs of each dyad. The educational program had the same duration and topics as RT but did not teach RT skills and had no tailored content.

Primary Outcomes

The main goal of the study was to set the stage for a future fully powered efficacy trial of RT versus control. The study exceeded benchmarks of the feasibility of recruitment (76%), data collection (83%-88%), fidelity to condition (98%), adherence to sessions (86% completed more than four sessions) and satisfaction with the assigned group (98%-100%).

Secondary Outcomes

Although the primary aim of the pilot trial was feasibility, the sample provided 80% power to detect a moderate to large effect size. Participation in RT was associated with statistical and clinically significant improvement in symptoms of depression, anxiety and post-traumatic stress among patients and caregivers, over and above control. These improvements maintained through the three-month follow-up.

Next Steps

The research team will use these data to conduct a fully powered randomized controlled trial with a large enough sample to allow for definitive conclusions on the benefit of RT for patients with acute brain injuries and their caregivers. If true efficacy is established, RT can be implemented as the true standard of care in the ICU.

of dyads assigned to Recovering Together were satisfied with the intervention

of dyads screened agreed to participate

of patients provided three-month follow-up data

of dyads completed at least four of six sessions

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