The proof of the effectiveness in app-based cognitive behavioural therapy for migraine - a prospective intervention study.

JRCT ID: jRCTs032220649

Registered date:20/02/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Migraine
• Date of first enrollment: 25/04/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Cognitive behavioural therapy
headache treatment app.

Outcome(s)

• Primary Outcome: Change in the number of migraine attack days per 4 weeks between baseline and the 12th week of treatment.

Secondary Outcome

efficacy endpoint
1) Change in the number of migraine attack days per 4 weeks between baseline and treatment periods 4, 8, 12 and 24 weeks.
2) Change in the number of migraine attacks per 4 weeks between baseline and treatment periods 4, 8, 12 and 24 week.
3) Change in number of headache days per 4 weeks between baseline and treatment weeks 4, 8, 12 and 24.
4) Change in mean migraine intensity per 4 weeks between baseline and treatment weeks 4, 8, 12 and 24.
5) The change in the number of acute headache medication days per 4 weeks between baseline and treatment periods 4, 8, 12 and 24 weeks.
6) Amount of change in MIDAS (Migraine Disability Assessment Scale) between treatment period 0 weeks and treatment periods 12 and 24 weeks.
7) Change in HADS (Hospital Anxiety and Depression Scale) between treatment week 0 and treatment weeks 12 and 24.

Safety endpoints
Adverse events and diseases, and other defects.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Men and women aged 18 years and over.
2) Patients with migraine without aura or migraine with aura (International Classification of Headache, 3rd edition codes 1.1, 1.2.1.1 or 1.3) at least twice a month or on at least 4 days at the time of obtaining consent and enrolment.
3) Patients on migraine prophylaxis medication, if not changed within 3 months.
4) Patients whose consent to participate in this study is obtained in writing.
5) Patients who use a smartphone on a daily basis.

Exclude criteria

1) Patients who have started or changed migraine prophylaxis medication within the last 3 months.
2) Patients treated with botulinum toxin or nerve blocks within the last 3 months.
3) Patients with secondary headache, excluding drug abuse headache.
4) Patients with severe neurological or psychiatric disorders.
5) Patients with serious complications such as cardiac, hepatic or renal disorders.
6) Patients who participated in any clinical trial in the 4 weeks prior to obtaining consent.
7) Other patients who are judged by the doctor to be unsuitable for the treatment.

Related Information

• Primary Sponsor: Hashidume Masahiro
• Secondary Sponsor: Kawata Yumi,Hedgehog MedTech, Inc.