To test, within a single-blind randomized controlled trial, the feasibility, acceptability, efficacy, and durability of a mind–body program (the Relaxation Response Resiliency Program for neurofibromatosis [3RP-NF]) vs an attention placebo control (Health Enhancement Program for NF [HEP-NF]), both delivered via group videoconferencing.Methods:
Sixty-three patients completed baseline assessments and were randomized. Primary outcomes were physical health and psychological quality of life (QoL), measured by the WHOQOL-BREF (World Health Organization QoL abbreviated instrument). Secondary outcomes were social relations and environment QoL, depression, anxiety, pain intensity, and pain interference.Results:
Sixty-three participants completed the intervention (100%) and 52 the 6-month follow-up (82.5%). Acceptability was 4.1 (5-point scale). Patients in the 3RP-NF showed greater improvement in physical health QoL (7.69; 95% confidence interval [CI]: 0.29–15.10; p = 0.040), psychological QoL (5.57; 95% CI: 0.17–11.34; p = 0.056), social relations QoL (10.95; 95% CI: 1.57–20.31; p = 0.021), environment QoL (8.02; 95% CI: 2.57–13.48; p = 0.005), and anxiety (−2.32; 95% CI: −3.96 to 0.69; p = 0.006) compared to those in HEP-NF, and gains were maintained at follow-up. Patients in the 3RP-NF did not improve more than those in HEP-NF on depression, with both groups showing improvement. Patients in the 3RP-NF with baseline pain ≥5 of 10 showed improvement in pain intensity from baseline to posttest (1.30; 95% CI: −2.26 to −0.34; p = 0.009) with effects maintained at follow-up; this improvement was not greater than that in HEP-NF. There were more treatment responders in the 3RP-NF group (p < 0.05).Conclusions:
The 3RP-NF delivered via videoconferencing was highly feasible and accepted by patients, and resulted in sustained improvement in QoL.Classification of evidence:
This study provides Class II evidence that for patients with NF, a mind–body program is superior to an attention placebo control in improving QoL.