Effectiveness of a Dialogue-based Online Intervention Against Migraine

Migraine Clinical Trial

— EU-OPTMi  

Official title:

Effectiveness of the Unguided Online Program Ceprica for the Treatment of Migraine: a Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04276142
• Other study ID #: ceprica trial
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: June 5, 2024

Study information

• Verified date: June 2023
• Source: Gaia AG
• Contact: Gitta Jacob, PD PhD
• Phone: +49 40 349930
• Email: gitta.jacob[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 migraine symptoms than an active control intervention providing psychoeducational content. Patients fulfilling ICHD-criteria for migraine will be randomized and allocated to either an intervention group, receiving ceprica in addition to treatment as usual, or a control group, which receives access to an active control intervention in addition to treatment as usual. The primary endpoint is the number of migraine days per month.

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 a psychoeducational control intervention 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 ceprica, as well as the psychoeducational control intervention, aer both delivered via the internet and protected by individually assigned passwords. This randomised controlled trial will include 306 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 and receive access to a psychoeducational control intervention, 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) and three months after allocation (T1).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: June 5, 2024
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18-65 at the time of screening
• fulfill diagnostic criteria of migraine (ICD-10: G43.0 or G43.1, confirmed either by upload of a medical document issued by a medical specialist or by a diagnostic phone/video call with a study physician who is experienced in headache diagnostics)
• age at onset of migraine <50y
• Migraine is present for at least 12 months at the time of study entry
• 4-14 migraine headache days per 28 days
• able and willing to give signed informed consent
• sufficient language skills in German

Exclusion Criteria:

• currently receiving preventive migraine medication within 60 days of T0, or planning to start another preventive treatment during the course of the study
• routinely taking, or planning to take, gepant-type acute migraine medication (e.g., rimegepant)
• Botulinum toxin A and B administered in the head or neck area within 4 months prior to T0
• patients with a history of failure to respond to 3 or more classes of migraine preventive treatments with good scientific evidence
• patients with regular intake of analgesics for other reasons than headache (e.g., chronic back pain, (rheumatoid) arthritis, cancer, injuries/accidents)
• patients with incomplete headache diaries at baseline (>6 non-consecutive days within 28 days missing)
• patients with substance use disorder

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.
• active control intervention (additional to treatment as usual)
the active control intervention contains psychoeducational content regarding migraine

Locations

Country	Name	City	State
Germany	GAIA	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Gaia AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic variables	age, gender, familial status, socioeconomic status, level of education, language ability	Baseline Assessment
Other	Treatment Satisfaction	Measured by Net Promoter Score	T1 Assessment
Other	Healthy lifestyle	physical activity, sleep hygiene, healthy diet	3 months
Primary	Number of days with migraine headache	Change since baseline in migraine headache days per 28 days; assessed via diary	3 months
Secondary	Migraine-related disability	assessed via the Headache Impact Test (HIT-6); scale range from 36-78	3 months
Secondary	Use of acute migraine medication	change from baseline in days with use of acute migraine medication per 28 days; assessed via diary	3 months
Secondary	Number of moderate/severe headache days	Change since baseline in moderate/severe headache days per 28 days; assessed via diary	3 months
Secondary	Migraine days responder rate	Proportion of participants achieving at least 50% reduction from baseline in migraine days	3 months
Secondary	Headache-related pain intensity	assessed via a categorical, four-point verbal rating scale (no pain, mild pain, moderate pain, severe pain) on each day of each 28-day diary period	3 months
Secondary	Functional impairment due to migraine	Assessed via the Functional Impairment Scale on each day of the 28-day diary period; scale range: 0-3	3 months
Secondary	Depressive symptoms	measured via Patient Health Questionnaire (PHQ-9); scale range: 0 to 27	3 months
Secondary	Anxiety symptoms	measured via Generalized Anxiety Disorder Assessment (GAD-7); scale range: 0 to 21	3 months
Secondary	Migraine attacks	Change since baseline in migraine attacks per 28 days; assessed via diary	3 months