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NeurofibromatosisNCT02298270

Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

A study testing The Relaxation Response Resiliency Program (3RP) via Skype in people with Neurofibromatosis and Neurofibromatosis I, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
The Relaxation Response Resiliency Program (3RP) via Skype
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteUnited States
Study dates
Mar 2014to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02140

Other trials in United States

About this study

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.

Being tested
The Relaxation Response Resiliency Program (3RP) via Skype
Keywords
Neurofibromatosis, NF I, NF 2, Schwannomatosis, Stress Management, Resiliency, Skype
Medical subject headings
Neurofibromatoses, Neurofibromatosis 1, Neurofibromatosis 2, Schwannomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Relaxation Response Resiliency Program (3RP) via SkypeBehavioural

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

Study groups in NCT02298270
Study groupRoleWhat they receive
Relaxation Response Resiliency ProgramExperimentalParticipants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
Receives: Behavioral: The Relaxation Response Resiliency Program (3RP) via Skype
Health EducationPlacebo comparatorParticipants 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.
Receives: Behavioral: The Relaxation Response Resiliency Program (3RP) via Skype

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfaction with Life (SWL)

    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.

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

  2. Quality of Life (WHOQOL-BREF)

    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.

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

Secondary outcomes (17)

  1. Perceived Stress Scale (PSS-10)

    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.

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

  2. The Pain Catastrophizing Scale (PCS)

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

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

  3. Pain Numerical Rating Scale (Pain NRS)

    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.

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

  4. Patient Health Quesionnaire (PHQ)

    The PHQ measures symptoms of depression and functional impairment.

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

  5. Brief Pain Inventory (BPI)

    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).

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

  6. Cognitive and Affective Mindfulness Scale (CAMS)

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

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

  7. Posttraumatic Growth Inventory (PGI)

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

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

  8. Interpersonal Reactivity Index (IRI)

    The IRI assesses the cognitive and affective dimensions of empathy.

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

  9. Distress Analogue Scales

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

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

  10. Epworth Sleepiness Scale (ESS)

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

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

  11. Measure of Current Status (MOCS-A)

    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.

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

  12. Life Orientation Test (LOT) Optimism Scale

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

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

  13. The Gratitude Questionnaire (GQ-6)

    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.

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

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

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

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

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

    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.

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

  16. Medical Outcomes Study (MOS) Social Support Survey

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02298270
Sponsor's protocol ID
2013P002605a
Status last verified
Jun 2016
First submitted
17 Nov 2014
Last updated
23 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing The Relaxation Response Resiliency Program (3RP) via Skype in people with Neurofibromatosis and Neurofibromatosis I, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction with Life (SWL) (time frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02298270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.

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