Health Condition 1: G437- Chronic migraine without aura
Conditions
Interventions
Intervention1: Cognitive Behavioral Therapy (CBT) plus Treatment as Usual (TAU): six weekly sessions of about 45 minutes over approximately 8 weeks, following a structured CBT-for-headache module cove
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: (i) meeting the ICHD-3 beta criteria of chronic migraine ii) age of at least 18 years and above ii) a minimum of 8 migraine days per month. A total of at least 15 headache days for more than 3 months (iii) psychological factors, such as dysfunctional thoughts, emotions, and behavior, or the experience of emotional distress, were associated with migraine
Exclusion criteria
Exclusion criteria: diagnosis of medication-overuse headache, secondary headaches, and other primary headaches currently taking a headache prophylactic medication (3-month wash-out) or therapy with botulinum toxin or neuromodulation during the trial period previous completed or current psychotherapy a severe mental disorder or medical comorbidity (which was likely to interfere with the ability to participate in therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment feasibility rate - Target: at least 70% of target sample size (n=40 per group) within 6-month recruitment period Retention rate - Target: at least 70% retention at 6-month follow-up in both groups Intervention adherence rate - Target: adherence to at least 75% of intervention sessions in both groups Data collection completion rate - Target: at least 80% completion of outcome measures at all assessment time pointsTimepoint: Baseline , 3 months , 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic Pain Acceptance - measured by Chronic Pain Acceptance Questionnaire (CPAQ) Migraine Disability - measured by Migraine Disability Assessment Test (MIDAS) Headache frequency - headache days per 28-day periodTimepoint: baseline, 3 months,6 months;Depression, anxiety, and stress - measured by Depression, Anxiety, and Stress Scale (DASS-21) Quality of life - measured by Migraine Specific Quality of Life Questionnaire (MSQ) Self-efficacy - measured by Chronic Headache Self-Efficacy Scale (CHASE) Medication usage - medication days Headache intensity - measured by 11-point numerical rating scale (NRS) Timepoint: Baseline, 3 months, and 6 months | — |
Countries
India
Contacts
Public ContactPrerna Sharma
Institute of human behaviour and allied sciences
Outcome results
None listed