Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Study Overview
=================
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.

Official Title
-----------------
Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Conditions
-----------------
Neurofibromatosis, Neurofibromatosis I, Neurofibromatosis 2, Schwannomatosis

Intervention / Treatment
-----------------
* Behavioral: The Relaxation Response Resiliency Program (3RP) via Skype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Can read and speak English at or above the 6th grade level Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis Exclusion Criteria: 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) Recent (within past 3 months) change in antidepressant medication Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months. Unable or unwilling to sign the informed consent documents Unable or unwilling to complete psychological assessments online via the REDCap system. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relaxation Response Resiliency Program<br>Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. | Behavioral: The Relaxation Response Resiliency Program (3RP) via Skype<br>* 8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.<br>|
| Placebo Comparator: Health Education<br>Participants will receive and 8-week general stress and health education program, with none of the active relaxation and resiliency-based components being tested in the experimental condition. | Behavioral: The Relaxation Response Resiliency Program (3RP) via Skype<br>* 8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Life (SWL) | The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Quality of Life (WHOQOL-BREF) | The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale (PSS-10) | The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| The Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Pain Numerical Rating Scale (Pain NRS) | The Pain NRS is a scale for patient self-reporting measurements of pain. The measure was depicted by REINS as a standard measure to use in Neurofibromatosis clinical trials. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Patient Health Quesionnaire (PHQ) | The PHQ measures symptoms of depression and functional impairment. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain (BPI-S) and the degree to which their pain interferes with common dimensions of feeling and function (BPI-I). | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Cognitive and Affective Mindfulness Scale (CAMS) | The CAMS measures the degree to which individuals experience their thoughts and feelings. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Posttraumatic Growth Inventory (PGI) | The PGI is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Interpersonal Reactivity Index (IRI) | The IRI assesses the cognitive and affective dimensions of empathy. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Distress Analogue Scales | The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session. | 
| Epworth Sleepiness Scale (ESS) | The Epworth Sleepiness Scale (ESS) has been widely used to assess a person's average level of daytime sleepiness in daily life. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Measure of Current Status (MOCS-A) | The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Life Orientation Test (LOT) Optimism Scale | The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| The Gratitude Questionnaire (GQ-6) | The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue) | The FACIT-Fatigue measures participants' tiredness, weakness, and difficulty conducting usual activities due to fatigue. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp) | The FACIT-Sp measures participants' spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| Medical Outcomes Study (MOS) Social Support Survey | The MOS Social Support Survey measures various dimensions of social support. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 
| The 14-Item Resiliency Scale (RS-14) | The RS-14 measures stress coping ability in the face of adversity. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurofibromatosis, NF I, NF 2, Schwannomatosis, Stress Management, Resiliency, Skype