Development and Evaluation of a cognitive behavioral therapy program as prophylactic treatment of migraine in adults
- Conditions
- 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 MigraineDSM-5-Diagnosis (F45.1): somatic symptom disorder, with predominant painDSM-5 Diagnosis (F54): Psychological factors affecting other medical conditions (migraine)G43Migraine
- Registration Number
- DRKS00011111
- Lead Sponsor
- Psychologisches Institut; Johannes Gutenberg-Universität Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 121
(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
(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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (i) number of headache days (period of 4 weeks; measured with an electronic online diary/App); <br>(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); <br>(iii) emotional stress, measured by the German version (DASS, Nilges & Essau, 2015) of the Depression Anxiety Stress Scales, (DASS, Lovibond & Lovibond (1995); <br>(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).<br><br>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 Outcome Measures
Name Time Method