Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02387177
• Collaborator: The Children's Tumor Foundation (Other)
• Enrollment: 51
• Location: 1
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neurofibromatoses	Behavioral: Stress Management Group 1; Behavioral: Stress Management Group 2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

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.	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.
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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Quality of life (WHO-QOLBREFadol) [Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)]

   Measures quality of life

Secondary Outcome Measures

1. Perceived Stress Scale (PSS-10) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   Situations in one's life over the past month/week are appraised as stressful

2. The Pain Catastrophizing Scale - Child Version (PCS-C) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   Measures how individuals experience pain

3. Patient Health Questionnaire for Adolescents (PHQ-A) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   Symptoms of depression and functional impairment

4. Pain Interference Index (PII) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   How much pain has interfered with their life

5. Child and Adolescent Mindfulness Measure (CAMM) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   Assesses mindfulness in children and adolescents

6. Interpersonal Reactivity Index (IRI) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   Assesses the cognitive and affective dimensions of empathy

7. Epworth Sleepiness Scale-Revised for Children (ESS) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   Measures how likely one is to doze off or sleep in certain situations

8. Gratitude Questionnaire Six-Item Form (GQ-6) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   Assesses individual differences in the proneness to experience gratitude in daily life

9. Life Orientation Test (LOT) Optimism Scale [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

   Individual differences in generalized optimism versus pessimism

10. Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

    Spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days

11. MOS (Support/Empathy) [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

    Measures recent thinking about the various dimensions of social support.

12. Measure of Current Status (MOCS) Part A [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

    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.

13. Generalized Anxiety Disorder 7-item (GAD-7) scale [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

    A brief measure for assessing generalized anxiety disorder

14. Quality of Life (WHOQOL-BREF) [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.

15. Satisfaction with life adolescent [Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)]

    measures global satisfaction with life

Other Outcome Measures

1. Demographics [Baseline (week 0)]

   Basic demographics

2. Expectancy Questionnaire [Baseline (week 0)]

   Measures how much the participant believes the intervention will work

3. Intent to Attend [Baseline (week 0)]

   Measures how likely and how motivated the participants is to attend the next session.

4. Participant Feedback - Program Satisfaction Questionnaire [Post-intervention (week 8)]

   Measures how satisfied the participant is with the intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• The Children's Tumor Foundation

Investigators

• Principal Investigator: Ana-Maira Vranceanu, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ana-Maria Vranceanu, PhD, Clinical Psychologist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02387177
• Other Study ID Numbers: 2014P000702
• First Posted: Mar 12, 2015
• Last Update Posted: Aug 17, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma

Study Results

No Results Posted as of Aug 17, 2018