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Completed

NCT Number: NCT02298270

Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

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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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Treatment and study plan

The Relaxation Response Resiliency Program (3RP) via Skype

Behavioral

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

Primary outcomes

  1. Satisfaction with Life (SWL)

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

    The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.

  2. 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.

Secondary outcomes

  1. Perceived Stress Scale (PSS-10)

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

    The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives.

  2. The Pain Catastrophizing Scale (PCS)

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

    The Pain Catastrophizing Scale (PCS) is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes.

  3. Pain Numerical Rating Scale (Pain NRS)

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

    The Pain NRS is a scale for patient self-reporting measurements of pain. The measure was depicted by REINS as a standard measure to use in Neurofibromatosis clinical trials.

  4. Patient Health Quesionnaire (PHQ)

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

    The PHQ measures symptoms of depression and functional impairment.

  5. Brief Pain Inventory (BPI)

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

    The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain (BPI-S) and the degree to which their pain interferes with common dimensions of feeling and function (BPI-I).

  6. Cognitive and Affective Mindfulness Scale (CAMS)

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

    The CAMS measures the degree to which individuals experience their thoughts and feelings.

  7. Posttraumatic Growth Inventory (PGI)

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

    The PGI is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events.

  8. Interpersonal Reactivity Index (IRI)

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

    The IRI assesses the cognitive and affective dimensions of empathy.

  9. Distress Analogue Scales

    Time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session.

    The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.

  10. Epworth Sleepiness Scale (ESS)

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

    The Epworth Sleepiness Scale (ESS) has been widely used to assess a person's average level of daytime sleepiness in daily life.

  11. Measure of Current Status (MOCS-A)

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

    The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction.

  12. Life Orientation Test (LOT) Optimism Scale

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

    The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.

  13. The Gratitude Questionnaire (GQ-6)

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

    The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude.

  14. Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue)

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

    The FACIT-Fatigue measures participants' tiredness, weakness, and difficulty conducting usual activities due to fatigue.

  15. Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp)

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

    The FACIT-Sp measures participants' spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days.

  16. Medical Outcomes Study (MOS) Social Support Survey

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

    The MOS Social Support Survey measures various dimensions of social support.

  17. The 14-Item Resiliency Scale (RS-14)

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

    The RS-14 measures stress coping ability in the face of adversity.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • The Children's Tumor Foundation

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2014
Registry last updated
Jun 23, 2016

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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