Ana-Maria Vranceanu1, Eric Riklin2, Vanessa L Merker2, Eric A Macklin2, Elyse R Park2, Scott R Plotkin2. 1. From the Behavioral Medicine Service (A.-M.V.), Benson-Henry Institute for Mind Body Medicine (E.R., E.R.P.), and Department of Neurology and Cancer Center (V.L.M., S.R.P.), Massachusetts General Hospital, Boston; Biostatistics Center (E.A.M.), Massachusetts General Hospital and Harvard Medical School, Boston, MA. avranceanu@partners.org. 2. From the Behavioral Medicine Service (A.-M.V.), Benson-Henry Institute for Mind Body Medicine (E.R., E.R.P.), and Department of Neurology and Cancer Center (V.L.M., S.R.P.), Massachusetts General Hospital, Boston; Biostatistics Center (E.A.M.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.
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.
RCT Entities:
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.
Authors: Christopher J Funes; Ryan A Mace; Erik A Macklin; Scott R Plotkin; Justin T Jordan; Ana-Maria Vranceanu Journal: J Neurooncol Date: 2019-05-02 Impact factor: 4.130
Authors: Brittain L Mahaffey; Daniel M Mackin; Ana-Maria Vranceanu; Lindsay Lofaro; Evelyn J Bromet; Benjamin J Luft; Adam Gonzalez Journal: J Health Psychol Date: 2018-07-16
Authors: Jonathan Greenberg; Sarah Carter; Ethan Lester; Christopher J Funes; Eric A Macklin; Scott Plotkin; Ana-Maria Vranceanu Journal: J Neurooncol Date: 2019-11-01 Impact factor: 4.130
Authors: Ann Lin; Ana-Maria Vranceanu; Mary Guanci; Danielle Salgueiro; Jonathan Rosand; Emily L Zale Journal: Neurocrit Care Date: 2020-04 Impact factor: 3.210
Authors: Ethan G Lester; Ryan A Mace; Sarah M Bannon; Paula J Popok; Melissa V Gates; Emma Meyers; Tara Tehan; Danielle Sagueiro; Jonathan Rosand; Eric A Macklin; Ana-Maria Vranceanu Journal: Neurocrit Care Date: 2021-04-21 Impact factor: 3.210
Authors: Jonathan Greenberg; Ann Lin; Paula J Popok; Ronald J Kulich; Robert R Edwards; Ana-Maria Vranceanu Journal: J Clin Psychol Med Settings Date: 2021-01-19