- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387177
Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
August 15, 2018 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stress Management Group 1
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
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Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
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Experimental: Stress Management Group 2
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
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Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life (WHO-QOLBREFadol)
Time Frame: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)
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Measures quality of life
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Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (WHOQOL-BREF)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
|
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.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Perceived Stress Scale (PSS-10)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Situations in one's life over the past month/week are appraised as stressful
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The Pain Catastrophizing Scale - Child Version (PCS-C)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Measures how individuals experience pain
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Patient Health Questionnaire for Adolescents (PHQ-A)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Symptoms of depression and functional impairment
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Pain Interference Index (PII)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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How much pain has interfered with their life
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Child and Adolescent Mindfulness Measure (CAMM)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Assesses mindfulness in children and adolescents
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Interpersonal Reactivity Index (IRI)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Assesses the cognitive and affective dimensions of empathy
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Epworth Sleepiness Scale-Revised for Children (ESS)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Measures how likely one is to doze off or sleep in certain situations
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Gratitude Questionnaire Six-Item Form (GQ-6)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Assesses individual differences in the proneness to experience gratitude in daily life
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Life Orientation Test (LOT) Optimism Scale
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Individual differences in generalized optimism versus pessimism
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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MOS (Support/Empathy)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Measures recent thinking about the various dimensions of social support.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Measure of Current Status (MOCS) Part A
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Generalized Anxiety Disorder 7-item (GAD-7) scale
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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A brief measure for assessing generalized anxiety disorder
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Satisfaction with life adolescent
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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measures global satisfaction with life
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expectancy Questionnaire
Time Frame: Baseline (week 0)
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Measures how much the participant believes the intervention will work
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Baseline (week 0)
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Participant Feedback - Program Satisfaction Questionnaire
Time Frame: Post-intervention (week 8)
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Measures how satisfied the participant is with the intervention
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Post-intervention (week 8)
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Intent to Attend
Time Frame: Baseline (week 0)
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Measures how likely and how motivated the participants is to attend the next session.
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Baseline (week 0)
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Demographics
Time Frame: Baseline (week 0)
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Basic demographics
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Baseline (week 0)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana-Maira Vranceanu, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
February 25, 2015
First Submitted That Met QC Criteria
March 6, 2015
First Posted (Estimate)
March 12, 2015
Study Record Updates
Last Update Posted (Actual)
August 17, 2018
Last Update Submitted That Met QC Criteria
August 15, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Heredodegenerative Disorders, Nervous System
- Neoplastic Syndromes, Hereditary
- Nerve Sheath Neoplasms
- Neurocutaneous Syndromes
- Peripheral Nervous System Neoplasms
- Neurofibromatoses
- Neurofibromatosis 1
- Neurofibroma
Other Study ID Numbers
- 2014P000702
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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