Pediatric Chronic Headache Trial

Phase 3

• Conditions: Headache
• Interventions: Behavioral: Coping Skills Training; Behavioral: Headache Education; Drug: Amitriptyline

• Registration Number: NCT00389038
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-21
• Last Update Posted: 2011-04-25
• Primary Completion: 2012-08
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• diagnosis of chronic daily headache based on definition of 15 or more headache days per month measured by a prospective daily headache diary
• females or males between the ages of 10-17
• PedMIDAS Disability Score > 20, indicating at least moderate disruption in daily activities

Exclusion Criteria

• medication overuse as defined in the ICHD-II criteria (NSAID or other simple analgesic on ≥ 15 days/ month for >3 months; triptan intake in any formulation ≥ 10 days/month on a regular basis of ≥ 3 months)
• current treatment with amitriptyline
• no other current prophylactic antimigraine medication within a period equivalent to < 5 half-lives of that medication before entering the screening phase
• other chronic pain condition such as juvenile primary fibromyalgia syndrome, complex regional pain syndrome-II
• abnormal findings on EKG
• current or past history of severe orthostatic intolerance or severe levels of orthostatic dysregulation (orthostatic hypotension or postural orthostatic tachycardia syndrome)
• significant documented developmental delay or impairments such as autism, cerebral palsy or mental retardation
• present or lifetime psychiatric diagnosis that meets DSM-IV criteria for bipolar disorder, major depressive disorder or psychosis
• PedMIDAS Disability Score of > 140, indicating need for multi-systemic therapies to address very significant level of disability
• youth who are pregnant, or those females who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods) or do not agree to be abstinent during the study
• disallowed medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coping Skills Training + Amitriptyline	Coping Skills Training	Behavioral coping skills training--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.
Headache Education + Amitriptyline	Headache Education	Behavioral headache education
Coping Skills Training + Amitriptyline	Amitriptyline	Behavioral coping skills training--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year.
Headache Education + Amitriptyline	Amitriptyline	Behavioral headache education

Primary Outcome Measures

Name	Time	Method
Headache diaries assess headache frequency.	Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.

Secondary Outcome Measures

Name	Time	Method
The Child Depression Inventory.	Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.
The PedsQL measures the impact of chronic illness and quality of life.	Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.
Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities.	Completed at Baseline, Week 20, and Months 3, 6, 9, and 12.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Mail Location 3015; 🇺🇸 Cincinnati, Ohio, United States