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

Completed · Not applicable

Conditions studied: Pediatric, Headache, Anxiety

In brief

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.

Key facts

Study ID

NCT01182051

Run by

Johns Hopkins University

People needed

15

Starts

2010-03-01

Expected to finish

2012-06-01

Last updated by the study team

2013-05-24

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• have a current diagnosis of chronic daily headache, tension-type headache, and/or migraine headache
• obtain a total score on the Screen for Child Anxiety Related Disorders (SCARED) in the clinical range (i.e., > 20)
• be between 7 and 17 years old
• have a parent/guardian who gives consent and agrees to participate
• be English speaking
• 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.

You may not qualify if…

• 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).

Where it is running

• Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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