Clinical trial NCT01182051: A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety
Official title: A Pilot Study of Family-based Cognitive-behavioral Therapy for Treating Chronic Pediatric Headache/Migraine and Comorbid Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric
Headache
Anxiety
Keywords: headache
anxiety
pediatric headache and anxiety
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Migraine Research Foundation
First posted: 2010-08-16
Enrollment: 15
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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).

Primary outcomes:
measure: Daily Headache and Anxiety Diary
timeFrame: Daily for three months
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: 2 months
Secondary outcomes:
measure: Pediatric Migraine Disability Assessment (PedMIDAS)
timeFrame: 2 months
measure: Pediatric Migraine Disability Assessment (PedMIDAS)
timeFrame: 3 months
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Golda S Ginsburg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: