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Abstract
Objective: 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.
GLOSSARY
- CI=
- confidence interval;
- HEP=
- Health Enhancement Program;
- HIPAA=
- Health Insurance Portability and Accountability Act;
- MCID=
- minimal clinically significant difference;
- NF=
- neurofibromatosis;
- NRS-11=
- 11-point Numeric Rating Scale;
- QoL=
- quality of life;
- RR=
- relaxation response;
- 3RP=
- Relaxation Response Resiliency Program;
- WHOQOL-BREF=
- World Health Organization Quality of Life abbreviated instrument
Footnotes
↵* These authors contributed equally to this work.
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
- Received December 1, 2015.
- Accepted in final form May 17, 2016.
- © 2016 American Academy of Neurology
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