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

CompletedNot applicableNCT01182051
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Pilot Study of Family-based Cognitive-behavioral Therapy for Treating Chronic Pediatric Headache/Migraine and Comorbid Anxiety
Conditions
Interventions
  • Behavioral: CBT or relaxation training
Sponsor
Johns Hopkins University
Collaborators
Migraine Research Foundation
Start date
2010-03
Primary completion
2012-06
Sex
All
Age range
from 7 Years to 17 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01182051