Raising Money for
2009 MRF Research Grantee
In 2012, Dr. Ginsburg finished evaluating the feasibility, acceptability, and preliminary impact of a family-based cognitive-behavioral therapy intervention for adolescents with chronic headache and/or migraine with anxiety compared to relaxation training. The findings suggest that both interventions were perceived as helpful.
FINAL REPORT: A Pilot Study of Family-Based Cognitive Behavioral Therapy for Treating Chronic Pediatric Headache/Migraine and Comorbid Anxiety
The purpose of this pilot study was to refine a family-based cognitive-behavioral therapy (CBT) intervention for youth with chronic tension headaches and/or migraines and excessive anxiety and to evaluate the feasibility, acceptability, and preliminary impact of the intervention.
A total of 15 families were randomized to the Children’s Headache and Anxiety Management Program (CHAMP; n = 9) or Relaxation Training (RELAX; n = 6). A total of 9 families completed all evaluations (4 in CHAMP, 5 in RELAX). Of these families, preliminary data indicate that both treatments were associated with symptom reduction and satisfaction. At post-treatment, all 4 CHAMP participants reported an average reduction in headache frequency of 42%. RELAX participants reported an average reduction in headache frequency of 22%. Children in both groups reported little to no headache-related disability at post-treatment according to the PedMIDAS. Average reduction in anxiety severity from pre- to post-treatment was 44% for CHAMP and 37% for RELAX. From pre- to post-treatment, parental reinforcement of illness behavior reduced by an average of 43% for CHAMP and 7% for RELAX parents. Children in both groups reported increased perceived control over anxiety. Consumer satisfaction was rated on a scale from 1 (not at all helpful) to 7 (very much helpful). Average satisfaction ratings were similar in both groups (6.13 for CHAMP and 5.45 for RELAX).
These findings suggest that both interventions were perceived as helpful by all participants. While the sample size of this pilot study is small and does not permit tests of efficacy, the preliminary findings are promising. We achieved our goal of refining the interventions and methods in preparation for a large clinical trial to fully evaluate the comparative efficacy of RELAX versus CHAMP.
Hypothesis vs. Findings
The primary aim of this study was to refine the interventions and evaluate the feasibility and acceptability of the intervention and methods (e.g., recruitment, assessments) and this aim was completed and validated. Manuals and handouts have been finalized. Moreover, of those families that completed the interventions, parents and children in both groups reported a high degree of satisfaction. However, recruitment goals for the study were not met. The reason for this is likely due to an underestimation of the funds needed for advertising.
The secondary aim was to compare the relative efficacy of CHAMP and RELAX for reducing anxiety and chronic headaches in youth. We hypothesized that CHAMP would result in greater reductions in both anxiety and headache frequency and severity compared to RELAX. As is the case with small pilot studies, this study was not powered to conduct a definitive test of the intervention’s efficacy. However, CHAMP did lead to greater reductions on measures of headache frequency (PedMIDAS) and parental reinforcement of illness behavior (ARCS). No differences were found between groups in terms of headache-related disability (PedMIDAS), IE-rated anxiety (PARS) or headache (CGI-S) severity, or child or parent reports of anxiety symptoms (SCARED).
There are several unanswered questions including:
- What is the relative efficacy of CHAMP versus RELAX?
- What role does parental accommodation of headache-related behavior play in maintaining and/or ameliorating headache severity, frequency, and disability?
- What are the most potent ingredients in family-based psychosocial interventions for children with chronic headaches and anxiety?
- What biological (e.g., heart rate, salivary cortisol), cognitive (e.g., locus of control, negative self-statements), and parental (e.g., accommodation, reinforcement) factors mediate treatment response?
Answering these questions would move the field forward by clarifying the mechanisms by which symptom reduction occurs and by providing information that could inform researchers and practitioners about what treatments are most effective, and how treatments can be personalized based on child and family characteristics to optimize outcomes.
What This Research Means to You
Findings from this small pilot study suggest that brief behavioral interventions, including CBT and relaxation, may reduce headache frequency, disability, and comorbid symptoms of anxiety in children. Furthermore, there may be an added benefit of the CHAMP treatment in terms of reducing parental accommodation of headache-related behaviors.