DSM-IV (307.89): Pain Disorder Associated With Both Psychological Factors and a General Medical Condition DSM-IV (316): Specified Psychological Factor Affecting Migraine DSM-5 (F45.1): Somatic Symptom Disorder with Predominant Pain DSM-5 (54): Psychological Factor Affecting Migraine G43
Conditions
Interventions
Group 1: Cognitive behavioral therapy including triggermanagement. The treatment program consists of 7 sessions group theray, each session lasting 90 minutes. The frequency is 1 session per week, i.e
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) substantial medical or psychiatric comorbidities that are deemed likely to interfere with the ability to participate in treatment; (iii) suicidal tendency; (iv) pregnant, planning pregnancy during trial period or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| parameters of therapeutic process: (i) patients’ treatment assessment (measured each session by the session questionnaire for patients in group therapy, GTS-P, Zoubek, 2013); (ii) therapists’ treatment assessment (measured each session by the session questionnaire for therapists in group therapy, GTS-T, Zoubek, 2013); (iii) total assessment of the group therapy (assessment by the patients after the last group therapy session, measured by a questionnaire developed by Klan, Caroli, Witthöft, Hiller, in preparation), (iv) therapists’ adherence (total group therapy [7 sessions], measured by a questionnaire developed by Klan, Caroli, Witthöft, Hiller, in preparation, based on a questionnaire for assessing therapists’ adherence by Weck, Neng, Richtberg, Jakob, & Stangier, 2015), (v) therapists’ competence (total group therapy [7 sessions], measured by a questionnaire based on the DCTS-G, by Rund, 2014 und the CTS (German Version by Weck, Hautzinger, Heidenreich, & Stangier, 2010) | — |
Secondary
| Measure | Time frame |
|---|---|
| (A) each 2 measures: prä- & post- intervention: (i) 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); (ii) emotional stress, measured by the German version (DASS, Nilges & Essau, 2015) of the Depression Anxiety Stress Scales, (DASS, Lovibond & Lovibond (1995); (iii) 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);. (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 (HTSAQ-G, Caroli, Klan, & Witthöft, in preparation) of the Headache Triggers Sensitivity and Avoidance Questionnaire (HTSAQ, Kubik & Martin, 2016); (vii) acceptance of chronic pain, measured by the Chronic Pain Acceptance Questionnaire, German version (CPAQ-D, Nilges, Köster, & Schmidt, 2007). (B) Evaluation of the feasibility of a daily electronic online headache diary (via web-portal or App) over a four-week period. Measures are: (i) number of headache days; (ii) headache index: mean daily headache rating (averaged headache intensity ratings from electronic diaries; (iii) amount of pain medication I: frequency of days with pain medication; (iv) amount of pain medication II: mean daily pain medication use (averaged count of pain medication); (v) amount of physical activity (count of minutes of daily physical activity). Furthermore, acceptability is measured one-time by an evaluation questionnaire for the patients. | — |
Countries
Germany
Contacts
Public ContactTimo Klan
Psychologisches Institut,Johannes Gutenberg Universität Mainz
Outcome results
None listed