Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01633008
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2012-06-29
Brief Title:
Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Acceptance and Commitment Therapy for Adolescents and Adults With Neurofibromatosis Type 1 and Chronic Pain A Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-01-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
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
Objectives
- To see if ACT can help treat chronic pain in adolescents and young adults who have NF1
Eligibility
- Adolescents and young adults between 12 and 21 years of age who have chronic pain associated with NF1
Design
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
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
Objectives
- To see if ACT can help treat chronic pain in adolescents and young adults who have NF1
Eligibility
- Adolescents and young adults between 12 and 21 years of age who have chronic pain associated with NF1
Design
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
Detailed Description:
Background
Neurofibromatosis type 1 NF1 is a genetic disorder that affects approximately 1 in 3500 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
Objectives
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
Eligibility
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
Design
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
Neurofibromatosis type 1 NF1 is a genetic disorder that affects approximately 1 in 3500 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
Objectives
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
Eligibility
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
Design
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-C-0155 | None | None | None |