In the present study, we investigated the efficacy of TCBT in PwM. TCBT showed favorable effects on decreasing days of headache, headache severity, migraine related disability, migraine effects on daily life, number of pain-relievers used for headache, depression, and anxiety. These effects were also present after one month of therapy discontinuation indicating persistency of the effects.
A systematic review of 24 studies showed the efficacy of psychological interventions in migraine . Behavioral therapies with different approaches are among the most suggested psychological interventions for PwM . Despite the observed efficacy in research setting, a gap in practice exists in delivering mental health services [25, 26]. Multiple factors have been suggested to contribute to this gap, including cost, patient willingness to pursue psychological interventions, adherence to therapy, and availability of trained personnel. With regards to patient willingness, a recent study indicated tendency in pursuing behavioral therapy among PwM especially in those with moderate to severe level; however, patients were not willing to pay for the therapy sessions when they did not have insurance coverage for such treatments .
While in-person behavioral therapy sessions cost considerable amounts for both the patient and health care system, implementing group-based sessions are less expensive and more practical. The transdiagnostic nature of TCBT means this technique can be used in a group-based setting with individuals suffering from different types of disorders and comorbidities [14, 15, 27]. This would further facilitate the process for therapists and centers delivering this service to enroll enough number of cases for a group. Given these characteristics, TCBT is more favorable for both the patient and health care delivery system [13, 27]. We designed the therapy modules within 10 sessions of two hours, as brief therapy modules have been suggested to increase feasibility of delivering care and patient adherence with favorable outcomes .
In the study by Sharma et al in 2017, 63 adolescents suffering concurrent anxiety and primary headache (episodic tension-type, migraine, or cluster headache) were divided into two groups of intervention and control. The intervention group underwent 12 weeks of group based TCBT while the control group only continued their previous pharmacotherapy. Improvements in the Headache Impact Test and Global Assessment Scale for Children were observed at the end of the study in both groups; however, results from the TCBT group were better than the control group . Also, improvement in the State Trait Anxiety Inventory was only observed in the TCBT group and not the control group. Of note, the study was limited by different baseline features of two groups, favoring the intervention group .
In the study by Klan et al. the efficacy of an integrative CBT program was assessed among 9 adults suffering migraine . The program consisted of 7 sessions, each lasting for 90 minutes. Patients reported a high satisfaction with therapy sessions, and the treatment integrity assessment and the qualitative interview by the patients were favorable as well. However, no statistically significant improvements in pre-treatment and post-treatment comparisons of the following tests were observed: The Headache Disability Inventory, The Pain Disability Index, Headache Impact Test, Depression Anxiety Stress Scales, Headache Management Self-Efficacy Scale-short form, Headache Triggers Sensitivity and Avoidance Questionnaire, and Chronic Pain Acceptance Questionnaire . The small number of participants has possibly been the main reason for lack of improvement in observed scores.
In another study, Sajadinejad et al. investigated the efficacy of 9 weeks of group-based CBT (one session each week) on 20 female patients suffering tension type headache or migraine. Researchers used headache disability inventory and Beck depression inventory before intervention, after 5 weeks of therapy and at the last therapy session. They reported improvements in headache disability and depression in the assessments performed after 5 and 9 weeks of therapy. Worth mentioning that the authors failed to report headache characteristics and its associated changes among their patients . Neither the study by Klan et al. nor the study by Sajadinejad et al had a control group for comparison.
In the current study, we found improved quantitative scores in all used questionnaires at the time of therapy termination (three-month follow-up), except for HIT score Also, the categorical MIDAS, HIT, and HADS-anxiety were not different between two groups, with only HADS-depression showing improvement. One month after therapy termination (four-month follow-up), all scores and categories of the mentioned outcome measures were improved in the intervention group compared to the control group. These findings indicate favorable outcome of TCBT among PwM in improving headache and associated disabilities, as well as concomitant anxiety and depression.
Regarding the persistency of behavioral therapy effects, it has been reported that the beneficial effects of CBT in patients suffering headaches and migraine would decline within several weeks of therapy termination . Here we did not find such declines on the therapeutic effects of TCBT based on the assessments performed one month after therapy termination. In-group comparison of outcome measures in the intervention group showed no change or improvement of outcomes from three-month to four-month follow-up, implying the short-term persistency of our intervention.
To have a better understanding of our findings, we need to see the demographics of our recruited cases: young females with a graduate degree in more than half of cases, with severe migraine, severe associated disability, and abnormal levels of anxiety and depression in most cases. We believe these patients were more likely to participate in the study given the level of distress they are bearing, compared to those with mild to moderate severity or disability and more controllable migraine. While our cases are probably not representative of all PwM, they show how effective TCBT could be in severe migraine cases. Moreover, anxiety and depression are known as precipitating factors for migraine that could lead to disease progression [31, 32]. Therefore, interventions affecting these factors could ultimately lead to a better patient-reported outcome. We speculate that changes in patients’ perspectives toward their daily lives and the accompanying anxieties have helped them to reconsider their habitude in dealing with problems. We think that TCBT have helped patients to strengthen their ability in dealing with their headache through new skills on controlling stress and coping with pain and distressing situations. Hence, their feelings of disability were significantly reduced, and they were able to implement the new learned skills in their lives, leading to the persistency of effects.
There are some limitations to the present study. First, most of our participants were young females. Considering that migraine is more prevalent among women and that women are more willing to pursue psychological interventions, this was inevitable in our recruitment process. Second, we were not able to follow up patients for more than one-month after therapy termination, given the limited funds and personnel. Therefore, we are not able to evaluate the long-term persistency of TCBT among PwM. Third, given the nature of our intervention, we were not able to mask patients or our therapist of the randomization status. We tried to reduce the placebo effect by holding a therapy session for the control group; but this probably would not eliminate the placebo effect completely considering the longer duration of therapy in the intervention group and their engagement with the therapy by working on their assignments. Fourth, we did not ask our patients to complete satisfaction surveys after each session of therapy. But they were asked to give verbal feedback at the end of each session, and they reported high levels of satisfaction. Despite these limitations, to the best of our knowledge this is the first study evaluating the efficacy of TCBT on adult PwM, compared to a control group receiving sham therapy session. Moreover, we provided a short-term follow-up evaluation which has not been done in many of the previous studies. Future studies with larger sample sizes, a more diverse patient population, and longer follow-ups are needed to confirm our findings.