A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety

This study has been completed.
Sponsor:
Collaborator:
Migraine Research Foundation
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01182051
First received: May 21, 2010
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

The primary aim of this proposal is to refine the intervention under investigation (i.e., family-based CBT) and evaluate the feasibility and acceptability of the intervention and methods (e.g., recruitment, assessments).

The secondary aim of this proposal is to compare the relative efficacy of an 8 session family-based cognitive-behavioral therapy (CBT) to Relaxation Training (RT) for reducing anxiety and chronic headaches in youth (N = 30) ages 7-17 years. It is hypothesized that CBT will result in greater reductions in both anxiety and headache frequency and severity compared to RT.


Condition Intervention
Pediatric
Headache
Anxiety
Behavioral: CBT or relaxation training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Family-based Cognitive-behavioral Therapy for Treating Chronic Pediatric Headache/Migraine and Comorbid Anxiety

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Daily Headache and Anxiety Diary [ Time Frame: Daily for three months ] [ Designated as safety issue: No ]
    Youth and parents will complete a daily headache and anxiety diary to track the frequency and severity of headaches and anxiety symptoms. In addition, the diary will assess medication use, missed school/activities, as well as antecedents and consequences.

  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The Pediatric Anxiety Rating Scale (PARS) will be completed by an independent evaluator to assess the severity of current (within the past week) anxiety symptoms in youth. The instrument consists of two sections. The first section contains a 50-item anxiety symptoms checklist. The second section assesses the severity and impairment of these symptoms. A total score is computed by summing the severity items. The measure has acceptable internal consistency, reliability, and convergent/divergent validity.


Secondary Outcome Measures:
  • Pediatric Migraine Disability Assessment (PedMIDAS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.

  • Pediatric Migraine Disability Assessment (PedMIDAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.

  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Pediatric Anxiety Rating Scale (PARS) will be completed by an independent evaluator to assess the severity of current (within the past week) anxiety symptoms in youth. The instrument consists of two sections. The first section contains a 50-item anxiety symptoms checklist. The second section assesses the severity and impairment of these symptoms. A total score is computed by summing the severity items. The measure has acceptable internal consistency, reliability, and convergent/divergent validity.


Enrollment: 15
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavioral therapy
Key treatment ingredients in CBT include psychoeducation, trigger identification, progressive muscle relaxation training, cognitive restructuring, problem solving, in vivo exposure, and relapse prevention (see Appendix I for an outline of the treatment manual).
Behavioral: CBT or relaxation training
8 weeks of CBT or relaxation training.
Active Comparator: Relaxation Training
RT will consist of progressive muscle relaxation training, diaphragmatic breathing, and thermal biofeedback.
Behavioral: CBT or relaxation training
8 weeks of CBT or relaxation training.

Detailed Description:

Chronic daily headache in children, as well as periodic migraine, is a prevalent, persistent, and debilitating pain condition affecting nearly 1 in 10 children. Emerging evidence suggests that affected youth also experience excessive and impairing symptoms of anxiety which may play a role in the etiology and/or maintenance of headache pain. Current behavioral treatments are effective in reducing headache frequency and intensity, however, many youth remain symptomatic and the exacerbating role of anxiety has largely been ignored. Moreover, current psychosocial treatments fail to incorporate parents in the therapeutic process. The current proposal is a pilot study designed to address the shortcomings of current behavioral treatments by evaluating the initial efficacy of a family-based cognitive-behavioral therapy (CBT) for youth who present with chronic tension headaches and migraines, and excessive anxiety. Rigorous scientific methods will be employed, including a randomized design, multiple informants and measures to assess key constructs, independent evaluators (IEs) to assess outcomes, and intensive training for therapists and IEs to assure a high quality of implementation. Using a pre-post experimental design, 30 youth with chronic tension headaches and/or migraines and anxiety will be randomly assigned to receive 8 weeks of family-based CBT or relaxation training (RT). IEs will complete assessments of child symptoms and functioning at pre and post-treatment and at one month follow-up. Youth in the family-based CBT condition are expected to evince greater reductions in both headache and anxiety frequency, severity, and duration. Results from this study will be used to make empirically informed modifications to the CBT treatment manual in order to facilitate replication and dissemination of the interventions to clinicians and researchers.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To determine eligibility, youth will complete an evaluation consisting of clinical interviews, self-, and parent-report measures.
  • To be included in the study, all children must:

    1. have a current diagnosis of chronic daily headache, tension-type headache, and/or migraine headache
    2. obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED) in the clinical range (i.e., > 20)
    3. be between 7 and 17 years old
    4. have a parent/guardian who gives consent and agrees to participate
    5. be English speaking
    6. not currently participating in other psychosocial treatments specifically directed at reducing head pain or anxiety.
  • For youth receiving prophylactic medication, it is preferable that they remain on a stable dose and agree to avoid medication changes while enrolled in the study. Thus, all participants will be permitted to continue with their prescribed medical/neurological treatment, however the use of medications (both prophylactic and over-the-counter analgesics) will be closely monitored.

Exclusion Criteria:

  • Youth will be excluded from the study if they have a medical or psychiatric condition contraindicating study treatment or warranting an alternative intervention (e.g., suicidality, depression).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182051

Locations
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Migraine Research Foundation
Investigators
Principal Investigator: Golda S Ginsburg, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Golda S. Ginsburg, Ph.D., Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01182051     History of Changes
Other Study ID Numbers: NA-00019444
Study First Received: May 21, 2010
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
headache
anxiety
pediatric headache and anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Headache
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014