Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

Neurofibromatoses Clinical Trial

Official title:

Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387177
• Other study ID #: 2014P000702
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Must be between the ages of 12 and 17

2. Can read and speak English at or above the 6th grade level

3. Diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider

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 participate in an intervention delivered via videoconferencing with Skype

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	The Children's Tumor Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Basic demographics	Baseline (week 0)
Other	Expectancy Questionnaire	Measures how much the participant believes the intervention will work	Baseline (week 0)
Other	Intent to Attend	Measures how likely and how motivated the participants is to attend the next session.	Baseline (week 0)
Other	Participant Feedback - Program Satisfaction Questionnaire	Measures how satisfied the participant is with the intervention	Post-intervention (week 8)
Primary	Quality of life (WHO-QOLBREFadol)	Measures quality of life	Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)
Secondary	Perceived Stress Scale (PSS-10)	Situations in one's life over the past month/week are appraised as stressful	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	The Pain Catastrophizing Scale - Child Version (PCS-C)	Measures how individuals experience pain	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	Patient Health Questionnaire for Adolescents (PHQ-A)	Symptoms of depression and functional impairment	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	Pain Interference Index (PII)	How much pain has interfered with their life	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	Child and Adolescent Mindfulness Measure (CAMM)	Assesses mindfulness in children and adolescents	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	Interpersonal Reactivity Index (IRI)	Assesses the cognitive and affective dimensions of empathy	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	Epworth Sleepiness Scale—Revised for Children (ESS)	Measures how likely one is to doze off or sleep in certain situations	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	Gratitude Questionnaire Six-Item Form (GQ-6)	Assesses individual differences in the proneness to experience gratitude in daily life	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	Life Orientation Test (LOT) Optimism Scale	Individual differences in generalized optimism versus pessimism	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	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	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	MOS (Support/Empathy)	Measures recent thinking about the various dimensions of social support.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	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.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	Generalized Anxiety Disorder 7-item (GAD-7) scale	A brief measure for assessing generalized anxiety disorder	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Secondary	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	Satisfaction with life adolescent	measures global satisfaction with life	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)