Clinical trial NCT03406208: Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
Official title: Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurofibromatoses
Neurofibromatosis 1
Neurofibromatosis 2
Schwannomatosis
Keywords: Psychiatry
Psychology
Psychosocial
Behavioral
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning.

Detailed description: The aims of this study are to compare the effect of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning. We will also examine the degree to which treatment-dependent improvements in quality of life are mediated by improvements in depression, anxiety, distress, mindfulness, gratitude, social support, empathy, optimism, coping, pain intensity and pain interference.

Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of NF1, NF2, or Schwannomatosis
* 18 years of age or older
* Is capable of completing and fully understanding the informed consent process, study procedures, and study assessments in English
* At least 6th grade self-reported reading level
* Self-reported difficulties coping with stress and NF-symptoms
* Score of 6 or higher on Perceived Stress Scale 4-Item (PSS-4)

Exclusion Criteria:

* Has major medical comorbidity not NF related expected to worsen in the next 12 months
* Recent (within past 3 months) change in antidepressant medication
* Recent (within past 3 months) participation in cognitive behavioral therapy or relaxation therapy
* Has significant mental health diagnosis requiring immediate treatment (e.g., bipolar disorder, psychotic disorder, active substance use dependence)
* Unable or unwilling to complete assessments electronically via REDCap
* Unable or unwilling to participate in group videoconferencing sessions

Primary outcomes:
measure: Change in Physical Quality of Life
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Change in Psychological Quality of Life
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Secondary outcomes:
measure: Social Quality of Life
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Environmental Quality of Life
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Depression
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Anxiety
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Social Support
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Gratitude
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Optimism
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Coping Strategies
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Mindfulness
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Empathy
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Pain Intensity
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Pain Interference
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
measure: Stress
timeFrame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fishbein NS, Vranceanu AM, Mace RA. Baseline characteristics of adults with neurofibromatosis enrolled on a psychosocial randomized controlled trial. J Neurooncol. 2022 Sep;159(3):637-646. doi: 10.1007/s11060-022-04104-6. Epub 2022 Aug 4.
citation: Bannon SM, Hopkins SW, Grunberg VA, Vranceanu AM. Psychosocial profiles of risk and resiliency in neurofibromatoses: a person-centered analysis of illness adaptation. J Neurooncol. 2022 Feb;156(3):519-527. doi: 10.1007/s11060-021-03928-y. Epub 2022 Jan 22.
citation: Mace RA, Doorley J, Bakhshaie J, Cohen JE, Vranceanu AM. Psychological resiliency explains the relationship between emotional distress and quality of life in neurofibromatosis. J Neurooncol. 2021 Nov;155(2):125-132. doi: 10.1007/s11060-021-03852-1. Epub 2021 Sep 27.
citation: Doorley JD, Greenberg J, Bakhshaie J, Fishbein NS, Vranceanu AM. Depression explains the association between pain intensity and pain interference among adults with neurofibromatosis. J Neurooncol. 2021 Sep;154(2):257-263. doi: 10.1007/s11060-021-03826-3. Epub 2021 Aug 19.
citation: Lester EG, Gates MV, Vranceanu AM. Mind-Body Therapy via Videoconferencing in Patients With Neurofibromatosis: Analyses of 1-Year Follow-up. Ann Behav Med. 2021 Feb 12;55(1):77-81. doi: 10.1093/abm/kaaa030.
citation: Vranceanu AM, Zale EL, Funes CJ, Macklin EA, McCurley J, Park ER, Jordan JT, Lin A, Plotkin SR. Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 23;7(10):e11008. doi: 10.2196/11008.