PMID- 32634485
OWN - NLM
STAT- MEDLINE
DCOM- 20210924
LR  - 20210924
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Linking)
VI  - 95
DP  - 2020 Aug
TI  - Virtual mind-body treatment for adolescents with neurofibromatosis: Study 
      protocol for a single-blind randomized controlled trial.
PG  - 106078
LID - S1551-7144(20)30156-7 [pii]
LID - 10.1016/j.cct.2020.106078 [doi]
AB  - BACKGROUND: Neurofibromatoses (NF) are a group of genetically distinct disorders 
      of the nervous system unified by the predisposition to nerve sheath tumors. 
      Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of 
      life and high psychosocial burden, there are no evidence-based interventions to 
      address these needs. This paper presents the study design and protocol for the 
      first randomized controlled trial (RCT) of a mind-body intervention for 
      adolescents with NF, Resilient Youth with NF (RY-NF), versus an educational 
      control group, Health Education for NF (HE-NF), both delivered in groups via 
      secure live video. METHODS: This is an ongoing, single-blind efficacy RCT. 
      Recruitment began in November 2019 and will continue until March 2022. We will 
      enroll 200 English-speaking, geographically diverse adolescents (ages 12-17) with 
      NF1 and NF2 who report significant distress or difficulty coping with their NF 
      symptoms. We will use a shared-baseline, linear mixed model to compare the effect 
      of RY-NF versus HE-NF on changes in quality of life (QoL) and psychosocial 
      outcomes from baseline to post-intervention, and 6- and 12-month follow-ups. We 
      will also develop NF-specific minimal clinically important difference (MCID) for 
      QoL variables, and conduct mediation and moderation analyses to understand 
      mechanisms of improvement. DISCUSSION: This study has important clinical and 
      public health implications for the psychosocial functioning of adolescents with 
      NF. It provides a model for efficient delivery of virtual psychosocial care for 
      adolescents with rare diseases. Plans for dissemination and implementation of the 
      RY-NF should efficacy be ascertained are also discussed.
CI  - Copyright (c) 2020 Elsevier Inc. All rights reserved.
FAU - Reichman, Mira
AU  - Reichman M
AD  - Integrated Brain Health Clinical and Research Program, Psychiatry Department, 
      Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 
      Boston, MA, United States of America. Electronic address: 
      mreichman@mgh.harvard.edu.
FAU - Riklin, Eric
AU  - Riklin E
AD  - Department of Psychology, Fordham University, Dealy 336, 441 East Fordham Rd, 
      Bronx, NY 10458, United States of America. Electronic address: 
      eriklin@fordham.edu.
FAU - Macklin, Eric
AU  - Macklin E
AD  - Biostatistics Center, Massachusetts General Hospital, 50 Staniford Street, St 
      560, Boston, MA 02114, United States of America. Electronic address: 
      emacklin@mgh.harvard.edu.
FAU - Vranceanu, Ana-Maria
AU  - Vranceanu AM
AD  - Integrated Brain Health Clinical and Research Program, Psychiatry Department, 
      Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 
      Boston, MA, United States of America; Harvard Medical School, One Bowdoin Square, 
      1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: 
      avranceanu@mgh.harvard.edu.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20200704
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Humans
MH  - *Neurofibromatoses
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Single-Blind Method
OTO - NOTNLM
OT  - Adolescent
OT  - Mind-body program
OT  - Neurofibromatoses
OT  - Quality of life
OT  - Resiliency
EDAT- 2020/07/08 06:00
MHDA- 2021/09/25 06:00
CRDT- 2020/07/08 06:00
PHST- 2020/03/30 00:00 [received]
PHST- 2020/06/24 00:00 [revised]
PHST- 2020/06/29 00:00 [accepted]
PHST- 2020/07/08 06:00 [pubmed]
PHST- 2021/09/25 06:00 [medline]
PHST- 2020/07/08 06:00 [entrez]
AID - S1551-7144(20)30156-7 [pii]
AID - 10.1016/j.cct.2020.106078 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2020 Aug;95:106078. doi: 10.1016/j.cct.2020.106078. Epub 
      2020 Jul 4.