Personalized combination treatment including cognitive behavioural therapy in chronic migraine and depression: A prospective randomized trial

Imtroduction. Personalized combination treatment including cognitive behavioural therapy (CBT) is a promising approach for managing chronic migraine (CM) and comorbid depressive syndrome.

Aim. To evaluate the effectiveness of adding CBT to personalized combination treatment for patients with CM and comorbid depressive syndrome.

Materials and methods. A total of 190 patients with CM and depressive syndrome (59 men and 131 women) were enrolled in the study. The mean age of patients was 35.8 ± 7.6 years. All patients underwent clinical interviews, neurological examination and testing. Patients were randomized into two groups: Group 1 received combination treatment, including pharmacological management of migraine, lifestyle recommendations, detoxification therapy (in the presence of drug-induced headache), therapeutic gymnastics (in the presence of musculoskeletal pain in other locations), sleep hygiene (in the presence of insomnia) and CBT, Group 2 received the same treatment, but without CBT. All patients had their clinical and psychological parameters assessed before treatment and at 3^rd, 6^th, 12^th and 18^th  months of observation.

Results. At Month 3 of treatment, Groups 1 and 2 showed statistically significant (p < 0.05) improvements: decreased frequency of headache (HF), analgesics use, migraine impact on daily activities, as well as reduced anxiety and depression. At Month 3 of treatment, in Group 1 the clinical effect (CE) for CM (a ≥50% reduction in HA frequency) was achieved in 74% of patients and depression symptoms regressed in 54% of patients; in Group 2, the CE for CM was observed in 41% of patients, and the absence of depression symptoms was noted in 31% of patients. The parameters were significantly better in Group 1 than in Group 2. From Month 6 to Month 18 of observation, Group 1 showed continuous improvement in parameters, while Group 2 experienced a reversal of positive changes they had previously achieved.

Conclusion. CBT increases the effectiveness of personalized combination treatment in patients with CM and comorbid depressive syndrome over the shortand long-term horizon.

1. Burch RC, Buse DC, Lipton RB. Migraine: Epidemiology, Burden, and Comorbidity. Neurol Clin. 2019;37(4):631–649. https://doi.org/10.1016/j.ncl.2019.06.001.

2. Viudez-Martínez A, Torregrosa AB, Navarrete F, García-Gutiérrez MS. Understanding the Biological Relationship between Migraine and Depression. Biomolecules. 2024;14(2):163. https://doi.org/10.3390/biom14020163.

3. Ashina S, Serrano D, Lipton RB, Maizels M, Manack AN, Turkel CC et al. Depression and risk of transformation of episodic to chronic migraine. J Headache Pain. 2012;13(8):615–624. https://doi.org/10.1007/s10194-012-0479-9.

4. Filatova EG, Osipova VV, Tabeeva GR, Parfenov VA, Ekusheva EV, Azimova YuE et al. Diagnosis and treatment of migraine: Russian experts’ recommendations. Neurology, Neuropsychiatry, Psychosomatics. 2020;12(4):4–14. (In Russ.) https://doi.org/10.14412/2074-2711-2020-4-4-14.

5. Golovacheva VA, Golovacheva AA. Efficacy of cognitive behavioral therapy in chronic migraine and medication overuse headache: a prospective randomized trial. Neurology, Neuropsychiatry, Psychosomatics. 2024;16(6):21–27. (In Russ.) https://doi.org/10.14412/2074-2711-2024-6-21-27.

6. Golovacheva VA, Golovacheva AA, Fateeva TG, Parfenov VA. Cognitive behavioral therapy in the treatment of patients with chronic migraine and concomitant chronic insomnia: a prospective, randomized trial. Zhurnal Nevrologii i Psikhiatrii imeni S.S. Korsakova. 2024;124(5-2):110–117. (In Russ.) https://doi.org/10.17116/jnevro2024124052110.

7. Golovacheva VA, Golovacheva AA, Parfenov VA. Optimizing the management of patients with chronic migraine and neck pain: a prospective randomized trial with long-term follow-up. Russian Neurological Journal. 2024;29(6):35–43. (In Russ.) https://doi.org/10.30629/2658-7947-2024-29-6-35-43.

8. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd ed. Cephalalgia. 2018;38(1):1–211. https://doi.org/10.1177/0333102417738202.

9. Henry SK, Grant MM, Cropsey KL. Determining the optimal clinical cutoff on the CES-D for depression in a community corrections sample. J Affect Disord. 2018;234:270–275. https://doi.org/10.1016/j.jad.2018.02.071.

10. Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression ScaleAnxiety (HADS-A). Arthritis Care Res. 2011;63(S11):S467–S472. https://doi.org/10.1002/acr.20561.

11. Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl. 1):S20–S28. https://doi.org/10.1212/wnl.56.suppl_1.s20.

12. Onur OS, Ertem DH, Karsidag C, Uluduz D, Ozge A, Sıva A, Guru M. An open/ pilot trial of cognitive behavioral therapy in Turkish patients with refractory chronic migraine. Cogn Neurodyn. 2019;13(2):183–189. https://doi.org/10.1007/s11571-019-09519-y.

13. Treadwell JR, Tsou AY, Rouse B, Ivlev I, Fricke J, Buse DC et al. Behavioral interventions for migraine prevention: A systematic review and metaanalysis. Headache. 2025;65(4):668–694. https://doi.org/10.1111/head.14914.

14. Kung D, Rodriguez G, Evans R. Chronic Migraine: Diagnosis and Management. Neurol Clin. 2023;41(1):141–159. https://doi.org/10.1016/j.ncl.2022.05.005.

15. Beck AT. A 60-Year Evolution of Cognitive Theory and Therapy. Perspect Psychol Sci. 2019;14(1):16–20. https://doi.org/10.1177/1745691618804187.

16. Bae JY, Sung HK, Kwon NY, Go HY, Kim TJ, Shin SM, Lee S. Cognitive Behavioral Therapy for Migraine Headache: A Systematic Review and Meta-Analysis. Medicina. 2021;58(1):44. https://doi.org/10.3390/medicina58010044.

17. Crawford MR, Luik AI, Espie CA, Taylor HL, Burgess HJ, Jones AL, Ong JC. Digital Cognitive Behavioral Therapy for Insomnia in Women With Chronic Migraines. Headache. 2020;60(5):902–915. https://doi.org/10.1111/head.13777.

18. Smitherman TA, Kuka AJ, Calhoun AH, Walters ABP, Davis-Martin RE, Ambrose CE et al. Cognitive-Behavioral Therapy for Insomnia to Reduce Chronic Migraine: A Sequential Bayesian Analysis. Headache. 2018;58(7):1052–1059. https://doi.org/10.1111/head.13313.

19. Calhoun AH, Ford S. Behavioral sleep modification may revert transformed migraine to episodic migraine. Headache. 2007;47(8):1178–1183. https://doi.org/10.1111/j.1526-4610.2007.00780.x.

20. Golovacheva VA. Treatment of chronic migraine and insomnia with cognitive behavioral therapy. Meditsinskiy Sovet. 2023;17(3):68–76. (In Russ.) https://doi.org/10.21518/ms2023-080.