Clinical trial NCT03873610: Resiliency Training in Adolescents With NF1 and NF2
Official title: Resiliency Training in Adolescents With NF1 and NF2; A Randomized Controlled Trial Via Secure Live Video Conferencing to Improve Emotional, Social and Physical Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurofibromatoses
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial for resiliency training in adolescents with Neurofibromatosis 1 and Neurofibromatosis 2 via secure live video to determine the efficacy two stress and symptom management programs. Both programs are 8 week group programs.

Detailed description: Neurofibromatosis (NFs) are rare genetic conditions with cure. Adolescents with NF experience more symptoms of depression and anxiety, higher levels of stress associated with coping with NF symptoms, lower levels of self esteem, difficulties with social skills and social support, high rates of learning disabilities, and more pain as compared with the general population norms.

The aims of this study are to compare the effect of two stress and symptom management programs tailored for adolescents 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, pain intensity and pain interference.

Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of NF1 or NF2 and is between the ages of 12-17
* Is capable of completing and fully understanding the informed consent process/assent and the study procedures and assessments in English; has parental approval for participation
* English speaking and at least a 3rd grade self-reported and parent reported reading level
* Self reported/parent reported difficulties coping with stress and NF symptoms

Exclusion Criteria:

* Has major medical co-morbidity not NF related expected to worsen in the next 12 months
* Recent (within past 3 months) change in antidepressant medication
* Recent participation in cognitive behavioral therapy or relaxation therapy (within past 3 months)
* Has significant mental health diagnosis requiring immediate treatment (e.g., untreated bipolar disorder, psychotic disorder, active substance dependence)
* Unable or unwilling to complete assessments electronically via REDCap
* Unable or unwilling to participate in group videoconferencing sessions
* Unable or unwilling to participate along with at least 1 parent in a video screening session

Primary outcomes:
measure: Change in Physical Health Quality of Life
timeFrame: 0 weeks, 8 weeks, 6 months,12 months
measure: Change in Psychological Health Quality of Life
timeFrame: 0 weeks, 8 weeks, 6 months,12 months
Secondary outcomes:
measure: Social relationships 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: Pain intensity
timeFrame: 0 weeks, 8 weeks, 6 months, 12 months
measure: Pain interference
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: