Behavioral treatment for migraine prophylaxis in adults: Moderator analysis of a randomized controlled trial.

BACKGROUND: While growing evidence suggests the efficacy of various behavioral approaches to the preventive treatment of migraine, it remains largely unclear which behavioral interventions are indicated for which type of patient. This exploratory study aimed to identify moderators for the outcome between migraine-specific cognitive-behavioral therapy and relaxation training. METHODS: In this secondary analysis of an open-label randomized controlled trial, the data of N = 77 adults (completer sample) with migraine (mean age = 47.4, SD = 12.2, 88% female), who were allocated to either migraine-specific cognitive-behavioral therapy or relaxation training, was examined. Outcome was the frequency of headache days at the 12-month follow-up. We analyzed baseline demographic or clinical characteristics and headache-specific variables (disability, emotional distress, trigger sensitivity and avoidance, pain acceptance, self-efficacy) as candidate moderators. RESULTS: Higher headache-related disability (assessed via the Headache Impact Test, HIT-6, B = -0.41 [95% CI: -0.85 to -0.10], p = .047), higher anxiety (assessed via the subscale Anxiety of the Depression, Anxiety and Stress scales, DASS-A, B = -0.66 [95% CI: -1.27 to -0.02], p = .056), and the presence of a comorbid mental disorder (B = -4.98, [95% CI: -9.42 to -0.29], p = .053), moderated the outcome in favor of migraine-specific cognitive-behavioral therapy. CONCLUSION: Our findings contribute to an individualized treatment selection and suggest that preference for complex behavioral treatment (migraine-specific cognitive-behavioral therapy) should be given to patients with high headache-related disability, increased anxiety, or a comorbid mental disorder.Study Registration: Original study registered in the German Clinical Trials Register (https://drks.de/search/de; DRKS-ID: DRKS00011111).

Determination of psychosocial factors in cluster headache - construction and psychometric properties of the Cluster Headache Scales (CHS).

BACKGROUND: Cluster headache (CH) is clinically associated with considerable psychosocial burden. However, instruments to assess and characterize psychosocial factors in cluster headache more specifically are lacking. This study aimed to develop a self-report questionnaire, which assesses the broadest possible spectrum of psychosocial factors in cluster headache, the Cluster Headache Scales (CHS). METHOD: Items of the Cluster Headache Scales were constructed based on a literature review and semi-structured interviews with several experts (including persons with cluster headache). A cross-sectional online survey was conducted to determine the psychometric properties and the factor structure of the Cluster Headache Scales. Data was analyzed using exploratory factor analysis as well as exploratory structural equation modelling (ESEM). RESULTS: In total, n = 342 subjects with cluster headache (mean age 47.8, 63% male, 51% with episodic cluster headache) were included. Factor analysis yielded eight clearly interpretable factors: Medical care, medication side effects, fear of attacks, disability, (auto)aggression, coping, physical activity, and financial burden, which are assessed via 36 items. The internal consistencies of the subscales were acceptable to excellent and ranged between Cronbach's alpha = .76 and .93. The pattern of correlations with related instruments provides first evidence for convergent validity. CONCLUSION: The CHS represents a reliable and valid self-report instrument for the assessment of psychosocial factors in persons with cluster headache, which appears useful for both clinical practice as well as research.Trial registration: The study was registered at the German Clinical Trials Register (www.drks.de, ID-Number: DRKS00016502).

An Integrative Cognitive Behavioral Therapy Program for Adults With Migraine: A Feasibility Study.

OBJECTIVE: To present a novel cognitive behavioral therapy program that was developed exclusively for adults with migraine, and to assess the feasibility of this program. BACKGROUND: Unlike previous efforts, we combined different approaches of behavioral therapy into one program: relaxation therapy, cognitive behavioral therapy, trigger management. METHODS: The treatment program consists of 7 sessions (including psychoeducation, lifestyle counseling, coping with fear of attacks, trigger management, and stress management). The research was conducted in a single-group study with N = 9 completers (age: M = 41.6, SD = 17.6 years; N = 8 female, N = 1 male; N = 5 migraine without aura, N = 2 migraine with aura, N = 2 chronic migraine). After each of the group therapy sessions, evaluation questionnaires were filled out, and individual qualitative interviews were conducted after completion of the program. RESULTS: The treatment program was very well accepted. Every session was rated as comprehensible, and overall satisfaction with the sessions was high. Participants greatly appreciated having access to a specific treatment, exclusively addressing migraine. CONCLUSIONS: The idea of combining several approaches of behavioral therapy into a specific treatment program for migraine seems to be feasible and promising. A randomized controlled trial to determine the efficacy of our program is currently running.

Integrated multidisciplinary care of headache disorders: A narrative review.

Background Recent evidence shows that multidisciplinary treatment is effective in chronic pain syndromes, especially in headache disorders. Aim The aim of this review is to summarize current knowledge on integrative care concepts in headache patients regarding the optimal and necessary treatment parts, optimal duration and setting. Methods We present a narrative review reporting current literature and personal experience. Results and conclusion Based on current knowledge, multidisciplinary treatment programs appear to be reasonable and efficient in headache disorders. Sufficient controlled studies regarding the need for individual parts of the integrative care approach are missing as yet. Recommendations are therefore at least partly based on personal experiences. It seems to be unambiguous that patients should be referred to a specialized headache center offering such a program instead of being sent sequentially to various medical specialists. The extent and kind of required therapy (e.g. personal consultation versus group sessions) is not known yet. All patients should learn relaxation training, although it is unclear yet which training is the best for which patient. Physiotherapy with guidance on more activity and individual exercises should be used in all patients. Some patients might benefit from cognitive behavioral therapy. However, therapies often depend more on country-specific health care systems than on clinical needs or scientific data.

Efficacy of Cognitive-Behavioral Therapy for the Prophylaxis of Migraine in Adults: A Three-Armed Randomized Controlled Trial.

Background: Behavioral approaches are central to the preventive treatment of migraine but empirical evidence regarding efficacy and effectiveness is still sparse. This study aimed to evaluate the efficacy of a newly developed migraine-specific, integrative cognitive-behavioral therapy program (miCBT) combining several approaches (trigger and stress management, coping with fear of attacks, relaxation training) by comparing it with a single behavioral approach (relaxation training, RLX) as an active control group and a waiting-list control group (WLC). Methods: In a three-armed open-label randomized controlled trial, 121 adults with migraine were assigned to either miCBT, RLX or WLC. The outpatient group therapy (miCBT or RLX) consisted of seven sessions each 90 min. Participants who completed the WLC were subsequently randomized to one of the two treatment groups. Primary outcomes were headache days, headache-related disability, emotional distress, and self-efficacy. The baseline was compared to post-treatment, and followed by assessments 4- and 12-months post-treatment to compare miCBT and RLX. Results: Mixed-model analyses (intention-to-treat sample, 106 participants) showed significantly stronger pre-post improvements in self-efficacy (assessed by the Headache Management Self-Efficacy Scale, HMSE-G-SF) in both treatment groups compared to the WLC (mean difference at post; miCBT: 4.67 [0.55-8.78], p = 0.027; RLX: 4.42 [0.38 to 8.46], p = 0.032), whereas no other significant between-group differences were observed. The follow-up analyses revealed significant within-group improvements from baseline to 12-month follow-up in all four primary outcomes for both treatments. However, between-group effects (miCBT vs. RLX) were not significant at follow-up. Conclusion: The miCBT has no better treatment effects compared to RLX in migraine-prophylaxis. Both treatments effectively increase patients' self-efficacy. Trial Registration: German Clinical Trials Register (www.drks.de; DRKS-ID: DRKS00011111).