Psychosocial and NF‐κB Activity Effects of the Stress Management and Resiliency Training: Relaxation Response Resiliency Program (SMART‐3RP) on Patients With MGUS and Smoldering Multiple Myeloma: A Randomized Waitlist Control Trial

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ABSTRACT Background Patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM), precursors to multiple myeloma, need supports for the psychological sequelae of medical uncertainty. Aims This secondary and exploratory analysis of psychosocial outcomes from a randomized controlled trial evaluated a mind‐body intervention, the Stress Management and Resiliency Training: Relaxation Response Resiliency Program (SMART‐3RP) for perceived stress, global distress and secondary distress (depression, anxiety, NF‐κB DNA‐binding activity) and well‐being (coping ability, mindfulness, optimism, gratitude) indices for individuals with MGUS and SMM. Methods Participants were randomized to immediate treatment (n = 45) or waitlist control (n = 48), providing data at baseline (T1), 3 months (T2), and 6 months (T3). Results Compared to waitlist control, the immediate treatment group experienced greater T1‐T2 reductions in global distress (Mdiff = −1.04, p = 0.04), but not perceived stress (Mdiff = −1.67, p = 0.12). Participants receiving immediate treatment also experienced greater reductions in depression (Mdiff = −4.22, p < 0.001) and improvements in coping abilities (Mdiff = 0.36, p < 0.001) and optimism (Mdiff = 1.39, p = 0.02), with no significantly different changes in mindfulness (Mdiff = 4.36, p = 0.14), anxiety (Mdiff = −1.23, p = 0.26), gratitude (Mdiff = 0.59, p = 0.47), or NF‐κB activity (Mdiff = −0.16, p = 0.23). Conclusions The SMART‐3RP demonstrated efficacy for global distress and other important outcomes for individuals with MGUS and SMM. Stress reduction did not significantly differ from waitlist control. Trial Registration: ClinicalTrials.gov Registration #: NCT01955395

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