Clinical trial NCT02298270: Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
Official title: Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatosis
Neurofibromatosis I
Neurofibromatosis 2
Schwannomatosis
Keywords: Neurofibromatosis
NF I
NF 2
Schwannomatosis
Stress Management
Resiliency
Skype
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Children's Tumor Foundation
First posted: 2014-11-21
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study tests the efficacy of an 8-week, Skype-based, group resiliency training intervention (The Relaxation Response Resiliency Program) for improving psychological stress in patients with Neurofibromatosis. A control group will receive a general health education curriculum. The investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program.

A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a sub-population: patients with NF2 who are hard of hearing.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Can read and speak English at or above the 6th grade level
3. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis

Exclusion Criteria:

1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
2. Recent (within past 3 months) change in antidepressant medication
3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
4. Unable or unwilling to sign the informed consent documents
5. Unable or unwilling to complete psychological assessments online via the REDCap system.
6. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.

Primary outcomes:
measure: Satisfaction with Life (SWL)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Quality of Life (WHOQOL-BREF)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The Pain Catastrophizing Scale (PCS)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Pain Numerical Rating Scale (Pain NRS)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Patient Health Quesionnaire (PHQ)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Brief Pain Inventory (BPI)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Posttraumatic Growth Inventory (PGI)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Interpersonal Reactivity Index (IRI)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Distress Analogue Scales
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session.
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Measure of Current Status (MOCS-A)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Life Orientation Test (LOT) Optimism Scale
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The Gratitude Questionnaire (GQ-6)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: Medical Outcomes Study (MOS) Social Support Survey
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
measure: The 14-Item Resiliency Scale (RS-14)
timeFrame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: