NCT02387177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

February 25, 2015

Last Update Submit

August 15, 2018

Conditions

Neurofibromatoses

Outcome Measures

Primary Outcomes (1)

  • Quality of life (WHO-QOLBREFadol)

    Measures quality of life

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

Secondary Outcomes (15)

  • Perceived Stress Scale (PSS-10)

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

  • The Pain Catastrophizing Scale - Child Version (PCS-C)

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

  • Patient Health Questionnaire for Adolescents (PHQ-A)

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

  • Pain Interference Index (PII)

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

  • Child and Adolescent Mindfulness Measure (CAMM)

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

  • +10 more secondary outcomes

Other Outcomes (4)

  • Demographics

    Baseline (week 0)

  • Expectancy Questionnaire

    Baseline (week 0)

  • Intent to Attend

    Baseline (week 0)

  • +1 more other outcomes

Study Arms (2)

Stress Management Group 1

EXPERIMENTAL

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

Stress Management Group 2

EXPERIMENTAL

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

Interventions

Stress Management Group 1BEHAVIORAL

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

Stress Management Group 1
Stress Management Group 2BEHAVIORAL

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

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neurofibromatoses

Condition Hierarchy (Ancestors)

NeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ana-Maira Vranceanu, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 12, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

US(1)