Back to resultsResiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
Primary Purpose
Neurofibromatoses
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Management Group 1
Stress Management Group 2
Sponsored by
About this trial
This is an interventional treatment trial for Neurofibromatoses
Eligibility Criteria
Inclusion Criteria:
- Must be between the ages of 12 and 17
- Can read and speak English at or above the 6th grade level
- Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider
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 participate in an intervention delivered via videoconferencing with Skype
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stress Management Group 1
Stress Management Group 2
Arm Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Outcomes
Primary Outcome Measures
Quality of life (WHO-QOLBREFadol)
Measures quality of life
Secondary Outcome Measures
Perceived Stress Scale (PSS-10)
Situations in one's life over the past month/week are appraised as stressful
The Pain Catastrophizing Scale - Child Version (PCS-C)
Measures how individuals experience pain
Patient Health Questionnaire for Adolescents (PHQ-A)
Symptoms of depression and functional impairment
Pain Interference Index (PII)
How much pain has interfered with their life
Child and Adolescent Mindfulness Measure (CAMM)
Assesses mindfulness in children and adolescents
Interpersonal Reactivity Index (IRI)
Assesses the cognitive and affective dimensions of empathy
Epworth Sleepiness Scale-Revised for Children (ESS)
Measures how likely one is to doze off or sleep in certain situations
Gratitude Questionnaire Six-Item Form (GQ-6)
Assesses individual differences in the proneness to experience gratitude in daily life
Life Orientation Test (LOT) Optimism Scale
Individual differences in generalized optimism versus pessimism
Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp)
Spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days
MOS (Support/Empathy)
Measures recent thinking about the various dimensions of social support.
Measure of Current Status (MOCS) Part A
Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed.
Generalized Anxiety Disorder 7-item (GAD-7) scale
A brief measure for assessing generalized anxiety disorder
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.
Satisfaction with life adolescent
measures global satisfaction with life
Full Information
NCT ID
NCT02387177
First Posted
February 25, 2015
Last Updated
August 15, 2018
Sponsor
Massachusetts General Hospital
Collaborators
The Children's Tumor Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02387177
Brief Title
Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
Official Title
Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
The Children's Tumor Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress Management Group 1
Arm Type
Experimental
Arm Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Arm Title
Stress Management Group 2
Arm Type
Experimental
Arm Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Group 1
Intervention Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Group 2
Intervention Description
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Primary Outcome Measure Information:
Title
Quality of life (WHO-QOLBREFadol)
Description
Measures quality of life
Time Frame
Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10)
Description
Situations in one's life over the past month/week are appraised as stressful
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
The Pain Catastrophizing Scale - Child Version (PCS-C)
Description
Measures how individuals experience pain
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Patient Health Questionnaire for Adolescents (PHQ-A)
Description
Symptoms of depression and functional impairment
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Pain Interference Index (PII)
Description
How much pain has interfered with their life
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Child and Adolescent Mindfulness Measure (CAMM)
Description
Assesses mindfulness in children and adolescents
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Interpersonal Reactivity Index (IRI)
Description
Assesses the cognitive and affective dimensions of empathy
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Epworth Sleepiness Scale-Revised for Children (ESS)
Description
Measures how likely one is to doze off or sleep in certain situations
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Gratitude Questionnaire Six-Item Form (GQ-6)
Description
Assesses individual differences in the proneness to experience gratitude in daily life
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Life Orientation Test (LOT) Optimism Scale
Description
Individual differences in generalized optimism versus pessimism
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp)
Description
Spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
MOS (Support/Empathy)
Description
Measures recent thinking about the various dimensions of social support.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Measure of Current Status (MOCS) Part A
Description
Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
A brief measure for assessing generalized anxiety disorder
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Quality of Life (WHOQOL-BREF)
Description
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.
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Title
Satisfaction with life adolescent
Description
measures global satisfaction with life
Time Frame
Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Other Pre-specified Outcome Measures:
Title
Demographics
Description
Basic demographics
Time Frame
Baseline (week 0)
Title
Expectancy Questionnaire
Description
Measures how much the participant believes the intervention will work
Time Frame
Baseline (week 0)
Title
Intent to Attend
Description
Measures how likely and how motivated the participants is to attend the next session.
Time Frame
Baseline (week 0)
Title
Participant Feedback - Program Satisfaction Questionnaire
Description
Measures how satisfied the participant is with the intervention
Time Frame
Post-intervention (week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be between the ages of 12 and 17
Can read and speak English at or above the 6th grade level
Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider
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 participate in an intervention delivered via videoconferencing with Skype
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maira Vranceanu, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
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