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Completed

NCT Number: NCT02387177

Resiliency Training for Adolescent Neurofibromatosis Patients Via Videoconferencing With Skype

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.

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Key information

Conditions

Neurofibromatoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurocutaneous Syndromes Neurodegenerative Diseases Neurofibroma

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Management Group 1

Behavioral

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

Behavioral

Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.

Primary outcomes

  1. Quality of life (WHO-QOLBREFadol)

    Time frame: Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36)

    Measures quality of life

Secondary outcomes

  1. Perceived Stress Scale (PSS-10)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    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.

  15. Satisfaction with life adolescent

    Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

    measures global satisfaction with life

Other outcomes

  1. Demographics

    Time frame: Baseline (week 0)

    Basic demographics

  2. Expectancy Questionnaire

    Time frame: Baseline (week 0)

    Measures how much the participant believes the intervention will work

  3. Intent to Attend

    Time frame: Baseline (week 0)

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

  4. Participant Feedback - Program Satisfaction Questionnaire

    Time frame: Post-intervention (week 8)

    Measures how satisfied the participant is with the intervention

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • The Children's Tumor Foundation

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 12, 2015
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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