Acceptance and Commitment Therapy for Adolescents and Adults With Neurofibromatosis Type 1 and Chronic Pain: A Pilot Study
- Neurofibromatosis type 1 (NF1) is a genetic disorder that affects approximately 1 in
- A number of common clinical manifestations, including plexiform neurofibromas,
scoliosis, and chronic headaches, 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, no studies have examined the effectiveness of behavioral
interventions for chronic pain in individuals 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 or distress.
- In helping individuals with pain, the goal of ACT is not to eliminate the person's
pain, but to optimize the person's quality of life despite their pain.
- To evaluate whether the Acceptance and Commitment Therapy (ACT) group demonstrates
improvement on the Modified Brief Pain Inventory scale from baseline to 3 months in
adolescents and young adults with NF1 and chronic pain.
- To examine changes in patient's functional ability, quality of life, pain-related
coping, pain-related anxiety, pain severity, and depression from baseline to 3 months
- To examine the effects of ACT on parents' psychological well-being, overall stress, and
ability to cope with their child's pain
- To explore the relationship between changes in patients' pain interference, functional
ability, pain-related coping, pain-related anxiety, pain severity, depression and
treatment adherence with demographic variables, parent stress, and parent coping
- To collect preliminary data on the value of ACT to guide the potential development of a
future phase II trial
Patients ages 12 to 21 with a confirmed diagnosis of NF1.-Parents of participating
patients.-The patient must indicate a score of 3 or higher on a pain item (1 - 5 scale) from
a quality of life measure assessing the extent to which pain has interfered with the
patient's daily functioning over the past month.
- This is a behavioral study to determine the feasibility and potential benefit of an ACT
intervention on pain interference from baseline to 3 months post-intervention.
- A sample size of 12 patients is needed to provide 90% power for detecting a change of
.77 standard deviations on the total pain interference score of the M-BPI using a
1-sided .1 level test.
- ACT workshops will be scheduled multiple times over approximately five months and will
be comprised of three 2-hour sessions held over two consecutive days
- Measures assessing pain interference, pain coping, pain-related anxiety, quality of
life, functional disability, depression, and pain severity will be administered to
patients prior to the ACT intervention and 3 months later.
- At the same time points, a parent or legal guardian of each patient will complete
measures assessing their child's quality of life, functional disability, depression,
and pain severity, as well as the parent's own psychological functioning and ability to
cope with their child's pain
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate whether Acceptance and Commitment Therapy (ACT) results in improvement on the Modified Brief Pain Inventory scale from baseline to 3 months in adolescents and young adults with NF1 and chronic pain.
Staci M Peron, Ph.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|