Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain
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|ClinicalTrials.gov Identifier: NCT01633008|
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : October 6, 2017
- Neurofibromatosis type 1 (NF1) is a genetic disorder that can cause frequent and significant pain. This pain can have a severe impact on a person s quality of life.
- Acceptance and Commitment Therapy (ACT) is a new type of therapy that may help people manage pain. It teaches behavioral techniques that can be used to change how people react to pain. ACT may help people with NF1 cope better with the pain associated with the disorder. Researchers want to test ACT techniques to see if they can improve coping in people with NF1 pain.
- To see if ACT can help treat chronic pain in adolescents and young adults who have NF1.
- Adolescents and young adults between 12 and 21 years of age who have chronic pain associated with NF1.
- Participants will be screened with a physical exam and medical history. They will also complete a set of questionnaires about their pain levels, quality of life, and medications that they are taking.
- Participants will take part in a training workshop for ACT. It will consist of three 2-hour sessions over 2 consecutive days. The workshop will teach techniques for setting goals that reflect personal values, and changing the focus from pain avoidance to pain management. There will be practice exercises between each session.
- At the end of the workshop, participants will receive a workbook with the exercises to continue to practice at home. Participants will be encouraged to spend at least 20 minutes, three times per week, on these practice exercises.
- There will be a followup phone call to check on pain management after the workshop.
- Three months after the first study visit, participants will complete the study questionnaires again from home. They will provide more information about how they are managing their pain. The questionnaires will be returned by mail in an envelope provided by the study team.
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis||Behavioral: ACT Workshop||Early Phase 1|
- 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, 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acceptance and Commitment Therapy for Adolescents and Adults With Neurofibromatosis Type 1 and Chronic Pain: A Pilot Study|
|Study Start Date :||June 15, 2012|
|Actual Primary Completion Date :||May 1, 2014|
|Actual Study Completion Date :||January 10, 2017|
Attend three 2-hour sessions held over two consecutive days
Behavioral: ACT Workshop
The ACT workshops will consist of a patient program and a corresponding parent program, each focusing on helping participants cope with the patient s pain more effectively using ACT techniques
- Pain improvement [ Time Frame: 3 months ]
- Value of the ACT for future Ph2 trial. [ Time Frame: 6 months ]
- Psychological well-being & stress changes in parents [ Time Frame: 3 months ]
- Explore improvements of pain interference, abilities, coping, anxiety,depression, etc [ Time Frame: 3 months ]
- Relationship between pain and treatment adherence [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633008
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Staci M Peron, Ph.D.||National Cancer Institute (NCI)|