Trial document




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  DRKS00011111

Trial Description

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Title

Development and Evaluation of a cognitive behavioral therapy program as prophylactic treatment of migraine in adults

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Trial Acronym

Mainz Migraine Trail

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URL of the Trial

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Brief Summary in Lay Language

Behavioral therapy is efficient in the treatment of migraine. However, it is still unknown, which combination of behavioral therapy components leads to the best results. The aim of this study is to compare different approaches in the behavioral treatment of migraine in adults. The behavioral treatment will be conducted in group therapy setting (7 sessions of 90 minutes each).

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Brief Summary in Scientific Language

The efficacy of behavioral treatment for migraine is well documented. Besides drug therapy, behavioral therapy (BT) or cognitive behavioral therapy (CBT) are important elements of prophylactic treatment of migraine in adults. Novel approaches of CBT for migraine include aspects of exposure to selected triggers of headaches to promote desensitization. The role of standard and novel approaches in the behavioral treatment of migraine needs further clarification. The aim of the study is to evaluate a specific CBT-program for migraine in adults in a randomized controlled trial.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011111
  •   2016/09/27
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  •   yes
  •   Approved
  •   837.291.16 (10610), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  •   U1111-1187-8988 
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Health Condition or Problem studied

  •   G43 -  Migraine
  •   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)"
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Interventions/Observational Groups

  •   cognitive behavioral therapy including triggermanagment, group therapy setting (7 weekly sessions of 90 minutes each)
  •   behavioral therapy comprising relaxation techniques, group therapy setting (7 weekly sessions of 90 minutes each)
  •   wait list control condition
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

(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

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Secondary Outcome

(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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/01/09
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Psychologisches Institut; Johannes Gutenberg-Universität Mainz
    • Mr.  Dr.  Timo  Klan 
    • Wallstr.3
    • 55122  Mainz
    • Germany
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    • Migräne- und Kopfschmerzklinik Königstein
    • Mr.  Dr.  Charly  Gaul 
    • Ölmühlweg 31
    • 61462  Königstein im Taunus
    • Germany
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    • Psychologisches Institut; Johannes Gutenberg-Universität Mainz
    • Mr.  Dr.  Timo  Klan 
    • Wallstr.3
    • 55122  Mainz
    • Germany
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    • Psychologisches Insitut;Johannes Gutenberg-Universität Mainz
    • Mr.  Dr.  Timo  Klan 
    • Wallstr.3
    • 55122  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Psychologisches Institut;Johannes Gutenberg-Universität Mainz
    • Wallstr.3
    • 55122  Mainz
    • Germany
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    • Deutsche Migräne- und Kopfschmerzgesellschaft e.V.
    • Ölmühlweg/31
    • 61462  Königstein im Taunus
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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  •   121
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Trial Publications, Results and other Documents

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