Clinical Trial: Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain: A Phase III Clinical Trial

Brief Summary:

Background:

- People with neurofibromatosis type I (NF1) and plexiform neurofibroma (PN) tumors often have chronic pain that his hard to control. People usually take medicines for the pain, but they may not work well and might cause side effects. A new strategy called Acceptance and Commitment Training (ACT) may help these people cope with chronic pain. ACT focuses on things like values and living in the moment.

Objective:

- To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain.

Eligibility:

- People age 16 34 who have NF1, 1 or more PN tumors, and pain that interferes with their daily functioning.

Design:

  • Participants will be screened with a physical exam, medical history, and questions about their pain.
  • Participants will fill out questionnaires about their pain and feelings. Their heart rate will be measured via ECG.
  • Participants will be divided into 2 groups randomly. One will wait 8 weeks.
  • The other will start training right away.
  • Participants will have 2 two-hour sessions with an ACT trainer. They will learn techniques for setting goals based on personal values and other ways to cope with pain. They will get a workbook and a CD to take home for practice.
  • Participants will do practice exercises at home between sessions. They will get weekly emails with a practice exercise. They will join video chat sessions via home computer with their

    Detailed Summary:

    BACKGROUND:

    • Neurofibromatosis type 1 (NF1) is a genetic disorder that affects approximately 1 in 3,500 individuals.
    • A number of common clinical manifestations, including plexiform neurofibromas, can cause frequent and significant pain and impact quality of life.
    • Often, NF1-related pain is not well-controlled with medication and many of the medications cause significant side effects.
    • To our knowledge, only one prior study (by our group) has examined the effectiveness of a psychological intervention for chronic pain in adolescents and young adults (AYA) with NF1.
    • Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain.
    • The goal of ACT is not to eliminate the person s pain, but to optimize the person s functioning despite their pain.

    PRIMARY OBJECTIVES:

    -To compare pain interference mean score changes from baseline to 8 weeks between the ACT intervention group and the waitlist (WL) group.

    SECONDARY OBJECTIVES:

    • To examine baseline to post-treatment changes in disease-related quality of life, pain severity, depression, pain-related anxiety, and heart rate variability (HRV), assessed by electrocardiogram (ECG).
    • To compare ACT with the WL group in terms of pre-post changes in disease-related quality of life, pain severity, depression, pain-related anxiety, and HRV.
    • compare pain interference mean score changes from baseline to 8 weeks [ Time Frame: 8 weeks ]
    • examine baseline to post-treatment changes in disease-related quality of life, pain severity, depression, pain-related anxiety, and heart rate variability (HRV) [ Time Frame: 8 weeks ]
    • Compare groups in terms of pre-post changes in diseaserelated quality of life, pain severity, depression, pain-related anxiety, and HRV [ Time Frame: 8 weeks ]
    • Examine the pattern of change from baseline to 8 weeks to 32weeks post-intervention [ Time Frame: 32 weeks ]
    • Examine mediators between pre- and post-treatment paininterference [ Time Frame: 1.5 years ]
    • Assess and compare the psychometric properties of the two pain interference measures (PII and PROMIS) [ Time Frame: 1.5 years ]


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: June 12, 2015
    Date Started: June 1, 2015
    Date Completion: June 30, 2018
    Last Updated: May 12, 2017
    Last Verified: April 17, 2017