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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 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. CONDITION: Neurological ‐ Multiple sclerosis Neurological ‐ Other neurological disorders Relapsing‐Remitting Multiple Sclerosis;Migraine; ; Relapsing‐Remitting Multiple Sclerosis ; Migraine PRIMARY OUTCOME: Change in migraine frequency, intensity and duration (measured using a headache diary).[Week 1 (before the treatment), Week 5 (at the end of treatment) (primary timepoint), and at 4‐week follow‐up. ] SECONDARY OUTCOME: Changes in cognitive functioning (measured on validated neuropsychological tests).[Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] Changes in fatigue measured on the Modified Fatigue Impact Scale.[Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] Changes in mood (measured on the Generalised Anxiety Disorder‐7 scale and Beck Depression Inventory II)[Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] Changes in psychological processes such as self‐efficacy will be measured using the Headache Management Self‐Efficacy scale.[Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] Changes in quality of life will be measured using the Multiple Sclerosis Quality of Life‐54 scale. INCLUSION CRITERIA: 1. Diagnosis of migraine 2. Diagnosis of relapsing‐remitting multiple sclerosis 3. English fluency 4. Medicare eligibility 5. Internet access ; [Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] Daily functioning such as work productivity and social activities will be measured using the Work Productivity and Activity Impairment questionnaire. [Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] Locus of control will be evaluated using the multidimensional Health Locus of Control scale).[Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] Sleep quality (measured on the Pittsburg Sleep Quality Index.[Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] The impact of migraine on daily life (measured on the Migraine Disability Assessment Test and Headache Impact Test).[Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] The participants' level of pain‐specific catastrophising will be assessed using the Pain catastrophising scale,[Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ] Treatment change expectancy will be measured using the Stanford Expectations of Treatment scale, [Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4‐week follow‐up. ]
Epistemonikos ID: 2c4462b233867593dd7b86c3dda3026110c65d23
First added on: Aug 25, 2024