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 stress management adapted for allo-HSCT caregivers would reduce distress compared with treatment as usual (TAU). Of 267 consecutive caregivers of allo-HSCT patients approached, 148 (mean=53.5 years, 75.7% female) were randomized to either psychosocial intervention (i=74) or TAU (n=74). Eight one-on-one 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, 95% confidence interval (95% CI)=17.9-22.0) compared with TAU (mean=23.0, 95% CI=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.

Figure 1

CONSORT diagram (24) representing subject flow and attrition through the study. From 267 patient-caregiver pairs approached, 149 were consented and 148 were randomized. Reasons for dropout are indicated as well as numbers available for analysis. See Footnote.

Figure 2

Primary psychological outcome of Perceived Stress Score (PSS) (18). Model predictions at Baseline and months 1 and 3 post-transplant for treatment as usual (TAU) [open symbols, broken line] and the intervention, Psychoeducation, Paced Respiration, and Relaxation (PEPRR), [filled symbols, solid line] with 95% CI at each collection time are shown. The horizontal broken line indicates the population mean in a healthy comparably aged population (40).

Figure 3

Secondary psychological outcome of anxiety based on the Spielberger State Anxiety Score (28). Model predictions at Baseline and months 1 and 3 post-transplant for treatment as usual (TAU) [open symbols, broken line] and the intervention, Psychoeducation, Paced Respiration, and Relaxation (PEPRR), [filled symbols, solid line] with 95% CI at each collection time are shown for this secondary psychological outcome. The horizontal broken line indicates the population mean in a healthy comparably aged population (28).

Figure 4

Secondary psychological outcome of depression based on the CESD (27). Model predictions at Baseline and months 1 and 3 post-transplant for treatment as usual (TAU) [open symbols, broken line] and the intervention, Psychoeducation, Paced Respiration, and Relaxation (PEPRR), [filled symbols, solid line] with 95% CI at each collection time are shown for this secondary psychological outcome. The horizontal broken line indicates the clinical cut off score for depression risk (27).