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

Conditions:Anxiety, Migraine Headaches
Therapuetic Areas:Neurology, Psychiatry / Psychology
Age Range:7 - 17
Start Date:March 2010
Contact:Kelly L Drake, Ph.D.

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A Pilot Study of Family-based Cognitive-behavioral Therapy for Treating Chronic Pediatric Headache/Migraine and Comorbid Anxiety

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.

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.

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).
We found this trial at
Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
Baltimore, MD
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