Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389038
Status:
UNKNOWN
Last Update Posted:
2011-04-25
First Post:
2006-10-16
Brief Title:
Pediatric Chronic Headache Trial
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Drug and Non-Drug Treatment of Pediatric Chronic Headache
Status:
UNKNOWN
Status Verified Date:
2011-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this trial is to evaluate the efficacy of combined behavioral and pharmacological treatment on chronic daily headache in children ages 10 to 17
Detailed Description:
Chronic daily headache CDH--defined as having headaches 15 or more days per month--is a frequent and debilitating condition in children that results in severe decreased quality of life and emotional stress Very little is known about the most effective types of treatment for CDH in children and adolescents Development of effective interventions for youth with CDH could potentially prevent the progression of a very painful and costly condition into adulthood Treatments combining pharmacological drug interventions with behavior change have been found effective in treating adults with chronic pain including headaches but have been understudied in children
The goal of this randomized controlled clinical trial is to determine the efficacy of combined behavioral and drug treatment of CDH in youth ages 10 to 17 In the study scientists will investigate if a combination of pain coping skills training CST and the drug amitriptyline AMI--CST-AMI--is effective in reducing headache frequency functional disability and symptoms of depression More specifically the researchers will evaluate if CST-AMI is superior to AMI combined with an attention control ATT The CST will mainly focus on learning skills for coping with pain and the ATT will focus on understanding chronic headaches and lifestyle information
Participants will be randomly assigned to one of the two treatment groups CST-AMI or ATT-AMI Those assigned to CST-AMI will complete 8 weekly sessions of coping training and 2 monthly maintenance-promoting sessions Sessions will focus on teaching biofeedback muscle relaxation techniques imagery distraction activity pacing problem solving and calming techniques using a treatment manual developed and tested in youth with CDH Those assigned to ATT-AMI will receive the same amount of therapist support and attention but not the active behavioral training All participants will receive the study medication AMI
Headache frequency functional disability pain and headache characteristics quality of life and symptoms of depression will be assessed before and after treatment and reassessed at 3 6 9 and 12 months For participants duration of the study--which includes treatment and follow-up phases--lasts about 18 months The treatment phase includes 12 study visits and the follow-up phase includes 4 study visits
The long-term objective of this research is to establish effective treatments for CDH in youth that lead to significantly reduced headache frequency and functional disability
The goal of this randomized controlled clinical trial is to determine the efficacy of combined behavioral and drug treatment of CDH in youth ages 10 to 17 In the study scientists will investigate if a combination of pain coping skills training CST and the drug amitriptyline AMI--CST-AMI--is effective in reducing headache frequency functional disability and symptoms of depression More specifically the researchers will evaluate if CST-AMI is superior to AMI combined with an attention control ATT The CST will mainly focus on learning skills for coping with pain and the ATT will focus on understanding chronic headaches and lifestyle information
Participants will be randomly assigned to one of the two treatment groups CST-AMI or ATT-AMI Those assigned to CST-AMI will complete 8 weekly sessions of coping training and 2 monthly maintenance-promoting sessions Sessions will focus on teaching biofeedback muscle relaxation techniques imagery distraction activity pacing problem solving and calming techniques using a treatment manual developed and tested in youth with CDH Those assigned to ATT-AMI will receive the same amount of therapist support and attention but not the active behavioral training All participants will receive the study medication AMI
Headache frequency functional disability pain and headache characteristics quality of life and symptoms of depression will be assessed before and after treatment and reassessed at 3 6 9 and 12 months For participants duration of the study--which includes treatment and follow-up phases--lasts about 18 months The treatment phase includes 12 study visits and the follow-up phase includes 4 study visits
The long-term objective of this research is to establish effective treatments for CDH in youth that lead to significantly reduced headache frequency and functional disability
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 |
|---|---|---|---|
| 1R01NS050536-01A1 | NIH | None | httpsreporternihgovquickSearch1R01NS050536-01A1 |