Development and Evaluation of a cognitive behavioral therapy program as prophylactic treatment of migraine in adults - Pilot study of Mainz Migraine Trail

Phase 1

• Conditions: DSM-IV (307.89): Pain Disorder Associated With Both Psychological Factors and a General Medical ConditionDSM-IV (316): Specified Psychological Factor Affecting MigraineDSM-5 (F45.1): Somatic Symptom Disorder with Predominant PainDSM-5 (54): Psychological Factor Affecting Migraine; G43; Migraine

• Registration Number: DRKS00011143
• Lead Sponsor: Psychologisches Institut,Johannes-Gutenberg Universität Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-30
• Study Completion: 2017-05-02
• Results First Posted: 2019-04-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

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

(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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
parameters of therapeutic process:<br>(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); <br>(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), <br>(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), <br>(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)<br>