Objective: This pilot study reports the findings of a randomized controlled trial (RCT) investigating the feasibility, tolerability, acceptability, and initial estimates of efficacy of mindfulness-based cognitive therapy (MBCT) compared to a delayed treatment (DT) control for headache pain. It was hypothesized that MBCT would be a viable treatment approach and that compared to DT, would elicit significant improvement in primary headache pain-related outcomes and secondary cognitive-related outcomes.
Materials and Methods: RCT methodology was employed and multivariate analysis of variance models were conducted on daily headache diary data and preassessment and postassessment data for the intent-to-treat sample (N=36), and on the completer sample (N=24).
Results: Patient flow data and standardized measures found MBCT for headache pain to be feasible, tolerable, and acceptable to participants. Intent-to-treat analyses showed that compared to DT, MBCT patients reported significantly greater improvement in self-efficacy (P=0.02, d=0.82) and pain acceptance (P=0.02, d=0.82). Results of the completer analyses produced a similar pattern of findings; additionally, compared to DT, MBCT completers reported significantly improved pain interference (P<0.01, d=−1.29) and pain catastrophizing (P=0.03, d=−0.94). Change in daily headache diary outcomes was not significantly different between groups (P’s>0.05, d’s≤−0.24).
Discussion: This study empirically examined MBCT for the treatment of headache pain. Results indicated that MBCT is a feasible, tolerable, acceptable, and potentially efficacious intervention for patients with headache pain. This study provides a research base for future RCTs comparing MBCT to attention control, and future comparative effectiveness studies of MBCT and cognitive-behavioral therapy.
*Department of Psychology, University of Alabama
†Psychology Service, V.A. Medical Center
‡Department of Psychiatry and Behavioral Medicine, The University of Alabama School of Medicine, Tuscaloosa
∥The Kilgo Headache Clinic, Northport, AL
§UC San Diego Center for Mindfulness, San Diego, CA
The authors declare no conflict of interest. This research was supported by the Anthony Marchionne Foundation, Pullman, Washington and the National Headache Foundation, Chicago, Illinois.
Reprints: Melissa A. Day, MA, Department of Psychology, University of Alabama, P.O. Box 870356, Tuscaloosa, AL 35487-0348 (e-mail: firstname.lastname@example.org).
Received August 25, 2012
Accepted January 12, 2013