Feasibility of a Randomized Controlled Trial Comparing CBT and Lifestyle Modification for Chronic Migraine: A Pilot Study in a North Indian Hospital Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruitment feasibility rate - Target: at least 70% of target sample size (n=40 per group) within 6-month recruitment period
研究概览
简要总结
This is a pilot randomized controlled trial to assess the feasibility of comparing Cognitive Behavioral Therapy (CBT) and lifestyle modification interventions for chronic migraine management in a North Indian hospital setting. The study will recruit 80 participants (40 per group) from the neurology outpatient department who meet ICHD-3 beta criteria for chronic migraine. Participants will be randomly assigned to receive either CBT + Treatment as Usual (TAU) or Lifestyle Modification + Treatment as Usual (TAU), delivered through 6 weekly sessions of 45 minutes each over approximately 8 weeks.
The primary focus is on evaluating feasibility outcomes including recruitment rates (target: 70% of sample within 6 months), retention rates (target: 70% at 6-month follow-up), intervention adherence (target: 75% session attendance), and data collection completion rates (target: 80% at all time points) rather than clinical effectiveness. Clinical outcomes will be assessed using the Chronic Pain Acceptance Questionnaire (CPAQ), Migraine Disability Assessment Test (MIDAS), headache frequency, Depression Anxiety Stress Scale (DASS), Migraine Specific Quality of Life Questionnaire (MSQ), and Chronic Headache Self-Efficacy Scale (CHASE) at baseline, 3 months, and 6 months.
This pilot study aims to provide essential data on study procedures, participant acceptability, intervention delivery challenges, and outcome measure variability to inform the design and sample size calculations for a future full-scale randomized controlled trial comparing these non-pharmacological interventions for chronic migraine in the Indian healthcare context. The findings will guide the development of culturally appropriate and accessible evidence-based management strategies for chronic migraine patients in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •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.
结局指标
主要结局
Recruitment feasibility rate - Target: at least 70% of target sample size (n=40 per group) within 6-month recruitment period
时间窗: Baseline , 3 months , 6 months
Retention rate - Target: at least 70% retention at 6-month follow-up in both groups
时间窗: Baseline , 3 months , 6 months
Intervention adherence rate - Target: adherence to at least 75% of intervention sessions in both groups
时间窗: Baseline , 3 months , 6 months
Data collection completion rate - Target: at least 80% completion of outcome measures at all assessment time points
时间窗: Baseline , 3 months , 6 months
次要结局
- Chronic Pain Acceptance - measured by Chronic Pain Acceptance Questionnaire (CPAQ)
- Depression, anxiety, and stress - measured by Depression, Anxiety, and Stress Scale (DASS-21)
研究者
Prerna Sharma
Institute of human behaviour and allied sciences