FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094998 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [LIFESTYLE MODIFICATIONS]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Testing whether we can study two different treatments - behavioral therapy and lifestyle modification - for people with frequent migraines in a North Indian hospital 
Scientific Title of Study   Feasibility of a Randomized Controlled Trial Comparing CBT and Lifestyle Modification for Chronic Migraine: A Pilot Study in a North Indian Hospital Setting 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prerna Sharma  
Designation  Associate Prof  
Affiliation  Institute of human behaviour and allied sciences  
Address  Room no 123, academic block , IHBAS , DILSHAD GARDEN , Delhi
Room no 123, academic block , IHBAS , DILSHAD GARDEN , Delhi
East
DELHI
110095
India 
Phone  9599620030  
Fax    
Email  prernasharma02@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prerna Sharma  
Designation  Associate Prof  
Affiliation  Institute of human behaviour and allied sciences  
Address  Room no 123, Academic block, IHBAS, Dept of clinical Psychology DILSHAD GARDEN , Delhi
Room no 123, Academic block, IHBAS, Dept of clinical Psychology DILSHAD GARDEN , Delhi
East
DELHI
110095
India 
Phone  9599620030  
Fax    
Email  prernasharma02@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prerna Sharma  
Designation  Associate Prof  
Affiliation  Institute of human behaviour and allied sciences  
Address  Room no 123, Academic block, IHBAS, Dept of clinical Psychology DILSHAD GARDEN , Delhi
Room no 123, Academic block, IHBAS, Dept of clinical Psychology DILSHAD GARDEN , Delhi
East
DELHI
110095
India 
Phone  9599620030  
Fax    
Email  prernasharma02@gmail.com  
 
Source of Monetary or Material Support  
Institute of human behaviour and allied sciences, Swami dayanand marg , dilshad garden , Delhi , 110095 
 
Primary Sponsor  
Name  NIL  
Address  NIL  
Type of Sponsor  Other [NIL ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   NIL  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prerna sharma   Institute of human behaviour and allied sciences   Room no 123, Academic block, IHBAS, Dept of clinical Psychology DILSHAD GARDEN , Delhi
East
DELHI 		 9599620030

prernsharma02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute of Human Behaviour & Allied Sciences, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G437||Chronic migraine without aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 covering psychoeducation, relaxation, trigger and threshold management, optimizing acute management, cognitive restructuring, and relapse prevention. 
Comparator Agent  Lifestyle Modification plus Treatment as Usual (TAU)  six weekly sessions of about 45 minutes over approximately 8 weeks, focusing on psychoeducation, diet and mindful eating, hydration practices, exercise routines, sleep hygiene, and general headache-related education 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  (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
 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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 points 		 Baseline , 3 months , 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
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 period 		 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)

 		 Baseline, 3 months, and 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
Close