A Study of Family-based Cognitive-behavioral Therapy for Chronic Pediatric Headache and Anxiety
Condition: Pediatric; Headache; Anxiety
MeSH terms: Headache; Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): CBT or relaxation training
Intervention type(s): Behavioral
Intervention description(s): 8 weeks of CBT or relaxation training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: headache; anxiety; pediatric headache and anxiety