EU-OPTMi: Effectiveness of a Dialogue-based Online Intervention Against Migraine
Study Details
Study Description
Brief Summary
This trial was designed to evaluate the effectiveness of a dialogue-based online intervention (ceprica) that provides information regarding cognitive behavioural therapy (CBT) in patients with migraine.
The study aims to test the hypothesis that ceprica has a greater positive impact on psychometric parameters than treatment as usual. Patients fulfilling ICHD-criteria for migraine will be randomized and allocated to either an intervention group, receiving ceprica for a period of three months in addition to treatment as usual, or a control group, which receives only treatment as usual. The primary endpoints are headache impact and migraine-related disabilities.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Migraine is common in the German population and leads to a decreased quality of life as well as high economic consequences. Cognitive behavioural therapy has shown to be effective in the treatment of migraine. Web-based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective.
In this study, the treatment effects of a novel dialogue-based online intervention compared to treatment as usual will be investigated. The interventional online program ceprica contains elements of cognitive behavioural therapy that address specific approaches in the management of pain, integrated in an individually tailored dialogue that is based on the responses given in the program. The intervention is delivered via the internet and protected by individually assigned passwords.
This randomised controlled trial will include 604 patients with migraine. Participants will be recruited via a website containing relevant information about the study. Participants will be randomly assigned in a 1:1 ratio to either a control group, in which they continue their usual treatment, or an intervention group who may also use treatment as usual and in addition receives the online intervention ceprica. Data are collected at baseline (T0), three months later (T1), and six months (follow-up assessment for stability of effects).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Migraine - ceprica online program: ceprica in addition to treatment as usual |
Behavioral: ceprica (additional to treatment as usual)
ceprica is a dialogue-based online psychological intervention for patients with migraine. This intervention includes elements that address pain management, pain reduction etc. Content is adapted to users needs using interactive dialogues, illustrations and audio files. Participants may also continue with their usual treatment.
|
| Other: Migraine - Treatment as usual Other: treatment as usual |
Other: treatment as usual
participants may continue with any treatment that they require (treatment as usual)
|
Outcome Measures
Primary Outcome Measures
- Impact of headaches on patients' normal daily activity [3 months]
assessed via the Headache Impact Test (HIT-6); scale range from 36-78
Secondary Outcome Measures
- Number of days with migraine-related disability [3 months]
assessed via Migraine Disability Assessment score (MIDAS); scale range from 0-92
- Number of headache days [3 months]
assessed via MIDAS item A, scale range from 0-92
- Headache-related pain intensity [3 months]
assessed via the Characteristic Pain Intensity score of the Chronic Pain Grade; scale range from 0-10
- HIT-6 Responder Rate [3 months]
percentage of participants with at least 1.5 points reduction in the HIT-6
- Depressive symptoms [3 months]
measured by Patient Health Questionnaire (PHQ-9); Scale Range: 0 to 27
Other Outcome Measures
- Sociodemographic variables [Baseline Assessment]
age, gender, housing situation, socioeconomic status, level of education
- Patient Satisfaction [T1 Assessment]
Measured by Patient Satisfaction (ZUF-8); scale range from 0 to 32
- Ability to work and socialize [3 months]
assessed by the total score of the Work and Social Ability Score; scale range from 0 to 40
- Healthy lifestyle [3 months]
physical activity, sleep hygiene, healthy diet
Eligibility Criteria
Criteria
Inclusion Criteria:
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age ≥ 18 (inclusive) at the time of screening
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fulfill diagnostic criteria of migraine (ICD-10: G43.-, verified by ICHD-3 algorithm)
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high impact of migraine symptoms on normal daily activities (HIT-6 score ≥ 56)
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able and willing to give signed informed consent
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sufficient language skills in German
Exclusion Criteria:
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currently receiving preventive migraine medication within 30 days of T0
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Botulinum toxin A and B administered in the head or neck area within 4 months prior to T0
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Patients with a history of failure to respond to 3 or more classes of migraine preventive treatments
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Gaia AG
Investigators
- Principal Investigator: Gitta Jacob, PD PhD, Gaia AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ceprica trial