Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-07-31

Brief Summary

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This study tests the efficacy of an 8-week, Skype-based, group resiliency training intervention (The Relaxation Response Resiliency Program) for improving psychological stress in patients with Neurofibromatosis. A control group will receive a general health education curriculum. The investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program.

A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a sub-population: patients with NF2 who are hard of hearing.

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Detailed Description

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Conditions

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Neurofibromatosis Neurofibromatosis I Neurofibromatosis 2 Schwannomatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Relaxation Response Resiliency Program

Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.

Group Type EXPERIMENTAL

The Relaxation Response Resiliency Program (3RP) via Skype

Intervention Type BEHAVIORAL

8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

Health Education

Participants will receive and 8-week general stress and health education program, with none of the active relaxation and resiliency-based components being tested in the experimental condition.

Group Type PLACEBO_COMPARATOR

The Relaxation Response Resiliency Program (3RP) via Skype

Intervention Type BEHAVIORAL

8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

Interventions

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The Relaxation Response Resiliency Program (3RP) via Skype

8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or older
2. Can read and speak English at or above the 6th grade level
3. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis

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 complete psychological assessments online via the REDCap system.
6. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No