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A Pilot Study of Cognitive Behavioural Therapy for Migraine in Multiple Sclerosis

Evaluation of a non-pharmacological approach: Pilot Randomised Controlled Trial of Cognitive Behavioural Therapy for Migraine in Multiple Sclerosis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000227796
Enrollment
31
Registered
2022-02-08
Start date
2022-07-07
Completion date
2023-10-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Individuals with MS and migraine can face difficulties with thinking skills (e.g. concentration and memory), mood, fatigue, work and social activities. However, to date, there has been no CBT program developed that is specifically tailored to these difficulties for individuals with MS and migraine. The project aims to assess how feasible and acceptable such a CBT program would be among people with MS and migraine. The brief cognitive behavioural therapy program will be conducted in five sessions across, with one-hour weekly sessions and a follow-up phone call 4-weeks later. The study will be conducted entirely on telehealth via internet, so participants can attend from home. Sessions will be on a one-on-one basis, with a neuropsychology registrar. The CBT program itself targets reducing the frequency and intensity of migraines, and in turn improve fatigue, low mood, anxiety, thinking skills, and work and social functioning. The techniques learnt in therapy aim to prevent migraines from occurring and when they do occur, lessen their impact on daily life. This CBT includes education about migraines, relaxation strategies, skills to adapt negative thoughts, and strategies to manage thinking skills difficulties (e.g. with concentration).

Interventions

Study Name: A Pilot Study of Cognitive Behavioural Therapy for Migraine in Multiple Sclerosis A brief cognitive behavioural therapy program will be conducted in five sessions across 5 weeks with one-hour weekly sessions and a follow-up phone call 4-weeks later. Therapy sessions will include education about migraine, relaxation strategies, ways of dealing with negative thoughts and emotions, and compensatory strategies to manage cognitive difficulties (e.g., concentration and memory). The study w

Study Name: A Pilot Study of Cognitive Behavioural Therapy for Migraine in Multiple Sclerosis A brief cognitive behavioural therapy program will be conducted in five sessions across 5 weeks with one-hour weekly sessions and a follow-up phone call 4-weeks later. Therapy sessions will include education about migraine, relaxation strategies, ways of dealing with negative thoughts and emotions, and compensatory strategies to manage cognitive difficulties (e.g., concentration and memory). The study will be conducted entirely on telehealth via internet, so participants can attend from home. Sessions will be on a one-on-one basis, with a neuropsychology registrar. Prior to three sessions, a series of questionnaires on migraine, day-to-day functioning and wellbeing will be sent to monitor progress, via an online link.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosis of migraine 2. Diagnosis of relapsing-remitting multiple sclerosis 3. English fluency 4. Medicare eligibility 5. Internet access

Exclusion criteria

1. Currently receiving psychological therapy or seeing a psychologist 2. Other diagnosed neurological disorder (e.g., traumatic brain injury, stroke, epilepsy) 3. Current severe psychiatric symptoms (e.g., psychosis, severe depression)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026