DSM-IV-Diagnosis (307.89): "Pain Disorder Associated With Both Psychological Factors and a General Medical Condition" DSM-IV-Diagnosis (316): "Specified Psychological Factor Affecting Migraine" DSM-5-Diagnosis (F45.1): "somatic symptom disorder, with predominant pain" DSM-5 Diagnosis (F54): "Psychological factors affecting other medical conditions (migraine)" G43
Conditions
Interventions
Group 1: cognitive behavioral therapy including triggermanagment, group therapy setting (7 weekly sessions of 90 minutes each)
Group 2: behavioral therapy comprising relaxation techniques, group the
Sponsors
Psychologisches Institut; Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (i) diagnosed as either “migraine without aura”, “migraine with aura”, or “chronic migraine” (according to ICHD-3 beta) ; (ii) minimum of 4 headache days per month, minimum migraine chronicity of 12 month, and pattern of migraine symptoms stable over last 6 months; (iii) psychological factors such as dysfunctional thoughts, emotions, behaviors are associated with migraine (i.e. DSM-IV diagnosis 307.89 or 316 or DSM-5 diagnosis F45.1 or F54); (iv) sufficient language ability (German language) and internet access
Exclusion criteria
Exclusion criteria: (i) diagnosis of Medication-Overuse-Headache (according to ICHD-3 beta); (ii) currently taking headache prophylactic medication (3-month wash-out) or therapy with botulinum toxin or neuromodulation during trial period; (iii) completed or current psychotherapy; (iv) substantial medical or psychiatric comorbidities that are deemed likely to interfere with the ability to participate in treatment; (v) suicidal tendency; (vi) pregnant, planning pregnancy during trial period or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (i) number of headache days (period of 4 weeks; measured with an electronic online diary/App); (ii) headache impact, measured by the German version (IBK, Bauer, Evers, Gralow, & Husstedt, 1999) of the Headache Disability Inventory (HDI, Jacobson, Ramadan, Aggarwal, and Newman (1994); (iii) emotional stress, measured by the German version (DASS, Nilges & Essau, 2015) of the Depression Anxiety Stress Scales, (DASS, Lovibond & Lovibond (1995); (iv) headache-specific self-efficacy, measured by the German short form (HMSE-G-SF, Graef, Rief, French, Nilges, & Nestoriuc, 2015) of the Headache Management Self-efficacy Scale (HMSE, French et al. 2000). MEASURES: Prä, Post (after the last i.e. the 7th goup-therapy session or - in the waitlist control group - after 7 weeks) , 4-month-follow-up, 12-month-follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) headache index: mean daily headache rating (averaged headache intensity ratings from electronic diaries, period of 4 weeks, one intensity-rating per hour each on a four-point scale with 0 = no headache, 1 = mild headache, 2 = moderate headache, 3 = severe headache); (ii) amount of pain medication I: frequency of days with pain medication (period of 4 weeks); (iii) amount of pain medication II: mean daily pain medication use (averaged count of pain medication, period of 4 weeks); (iv) headache impact II, measured by the German version (PDI, Nilges, Saile, & Gerbershagen, 1994) of the Pain Disability Index (Tait, Pollard, Margolis, Duckro, & Krause, 1987); (v) headache impact III, measured by the German version of the HIT-6TM (Kosinski et al., 2003); (vi) sensitivity to headache triggers and avoidance of headache triggers, measured by the German version (FTVK, Caroli, Klan, & Witthöft, in preparation) of the Headache Triggers Sensitivity and Avoidance Questionnaire (HTSAQ, Kubik & Martin, in preparation); (vii) participation in working life (days of work absence during the last 4 weeks); (viii) amount of physical activity (count of minutes of daily physical activity; period of 4 weeks); (ix) acceptance of chronic pain, measured by the german version (CPAQ-D, Nilges, Köster, & Schmidt, 2007) of the Chronic Pain Acceptance Questionnaire (CPAQ, McCracken, Vowles, & Eccleston (2004); (x) parameters of therapeutic process, including therapists’ adherence, therapists’ competence, patients’ and therapists’ treatment assessment (measured by the Questionnaire of Grouptherapy Sessions, GTS, Zoubek, 2013); i - iii, viii each measured with an electronic online diary/App; MEASURES: Prä, Post, 4-month-follow-up, 12-month-follow-up | — |
Countries
Germany
Contacts
Public ContactTimo Klan
Psychologisches Insitut;Johannes Gutenberg-Universität Mainz
Outcome results
None listed