A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: effects on distress

Abstract

Caregivers of patients receiving allogeneic hematopoietic stem cell transplants (Allo-HSCT) serve a pivotal role in patient care but experience high stress, anxiety, and depression as a result. We theorized that a stress management adapted for Allo-HSCT caregivers would reduce distress compared to treatment as usual (TAU). From 267 consecutive caregivers of Allo-HSCT patients approached, 148 (mean=53.5 years, 75.7% female) were randomized to either psychosocial intervention (n=74) or TAU (n=74). Eight 1-on-1 stress management sessions delivered across the 100 day post-transplant period focused on understanding stress, changing role(s) as caregiver, cognitive behavioral stress management, pacing respiration, and identifying social support. Primary outcomes included perceived stress (psychological) and salivary cortisol awakening response (CAR) (physiological). Randomized groups were not statistically different at baseline. Mixed models analysis of covariance (intent-to-treat) showed that intervention was associated with significantly lower caregiver stress 3 months post-transplant (Mean=20.0, CI95=17.9-22.0) compared to TAU (Mean=23.0, CI95=21.0-25.0) with an effect size (ES) of 0.39 (p=0.039). Secondary psychological outcomes, including depression and anxiety, were significantly reduced with ESs of 0.46 and 0.66 respectively. Caregiver CAR did not differ from non-caregiving controls at baseline and was unchanged by intervention. Despite significant caregiving burden, this psychosocial intervention significantly mitigated distress in Allo-HSCT caregivers.

An evidence-based stress management intervention for allogeneic hematopoietic stem cell transplant caregivers: development, feasibility and acceptability

“…The intervention, integrating cognitive behavioral strategies, psychoeducation, coping skills training and problem-solving as well as strategies for managing uncertainty, proved effective in decreasing caregiver stress, anxiety and depression [13]. Using the National Institutes of Health (NIH) stage model of intervention development [14], herein we describe stage I (intervention generation through adaptation of a previously tested intervention and pilot testing) and treatment fidelity issues of stage III (study design, provider training, treatment delivery, receipt and enactment of treatment skills [15]).…”

Intraindividual Cortisol Variability and Psychological Functioning in Caregivers of Hematopoietic Stem Cell Transplant Patients

“…As recommended by others[27], we required a stringent factor score of 0.70 or greater for inclusion in the composite. Our resulting Caregiver Mental Health Composite score differs from a PCA on 5 of these variables (dubbed Caregiver Distress score) previously reported [17, 28]. …”

“…This common factor (termed CG-MH) was coded such that higher scores indicated poorer mental health. CG-MH differs from a previously reported PCA (dubbed Caregiver Distress score), which included the Impact of Events scale, and not SF-36 MH [17, 28]. Correlations among all psychological variables tested for the PCA, in addition to the primary cortisol outcome of interest, are included in Table S1, Supplemental Digital Content 1.…”

Engaging Patients in Setting a Patient-Centered Outcomes Research Agenda in Hematopoietic Cell Transplantation

“…Additionally, often autologous and allogeneic HCT patients are grouped together in studies, yet their experiences and recovery courses are drastically different [7–12]. There is a lack of focus on specific psychological, social, and emotional concerns of caregivers [11–14]. Additionally, there is a limited focus on comprehensively understanding the psychological, emotional, and social challenges faced by HCT survivors more than one year post-HCT, in part due to limited access as survivors move away from their HCT centers.…”