An interventional study of Cognitive Behavioral Therapy (CBT) and Traditional Integrated Islamic Psychotherapy (TIIP) in Chronic Migraine Headache, sponsored by GIFT University. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by GIFT University · Not applicable, Interventional, and Health services research
Among 13 studies in Migraine Disorders with a site in Pakistan — 7 open to participants now, 8 under way, none of them phase 3. Migraine Disorders · Pakistan.
Among the 13 studies in Migraine Disorders with a site in Pakistan, this one is the 8th largest by enrollment, is one of 5 that started in 2025, is one of 13 with no phase, and was the 13th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →7 of the 13 studies in Migraine Disorders with a site in Pakistan are open now. Recruiting first, the newest first:
Muhammad Aamir Latif · Sites in Pakistan
Ages 8–15
Riphah International University · Sites in Pakistan
Ages 18+
Riphah International University · Sites in Pakistan
Ages 18+
Riphah International University · Sites in Pakistan
Ages 18–65
Riphah International University · Sites in Pakistan
Ages 18+
A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 40 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2021; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 45 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 50 across the 13 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 13 has an industry lead sponsor. The 6 most frequent:
GIFT University is the lead sponsor of 8 studies on the registry; none are open to participants now.
GIFT University has 1 study filed under Migraine Disorders — fewer than ten, so there is no comparison to draw.
1 of the studies in Migraine Disorders with a site in Pakistan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07743255Nishtar Medical UniversityPreventive Role of Melatonin and Propranolol Administration in Pediatric Migraine | 2026-12-10 |
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Among the 13 studies in Migraine Disorders with a site in Pakistan, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
his randomized controlled trial aims to evaluate the efficacy of Cognitive Behavioral Therapy (CBT) and Traditional Integrated Islamic Psychotherapy (TIIP) as psychological interventions for individuals with chronic migraine. The study will compare the effects of CBT and TIIP with a medication-only control group on migraine-related disability, headache management self-efficacy, psychological distress, and quality of life.
Chronic migraine is a disabling neurological condition that is frequently associated with psychological distress, reduced self-efficacy in headache management, and impaired quality of life. Although pharmacological treatment is commonly used to manage migraine, psychological interventions may provide additional benefits by addressing cognitive, emotional, behavioral, and coping-related factors associated with migraine.
The present study is a three-arm, parallel-group randomized controlled trial designed to evaluate and compare the efficacy of Cognitive Behavioral Therapy (CBT) and Traditional Integrated Islamic Psychotherapy (TIIP) among individuals with chronic migraine. A total of 45 participants meeting the study's eligibility criteria will be recruited and randomly allocated to one of three groups: (1) CBT, (2) TIIP, or (3) medication-only control group, with 15 participants in each group through Fish Bowl sampling,
Participants assigned to the CBT group will receive six weekly individual sessions, with each session lasting approximately 45-60 minutes. The intervention will focus on psychological and behavioral factors relevant to migraine management, including identification and modification of maladaptive thoughts, coping strategies, stress management, behavioral techniques, and headache-related self-management.
Participants assigned to the TIIP group will also receive six weekly individual sessions of approximately 45-60 minutes. TIIP will integrate Islamic psychological and spiritual principles with therapeutic techniques relevant to migraine management. The intervention will incorporate Qur'anic engagement, particularly Surah Al-Rahman, alongside concepts such as Tawheed, Fitrah, Qalb, Aql, Nafs, and Tazkiyah, with emphasis on spiritual coping, emotional regulation, cognitive reframing, gratitude, patience, and adaptive responses to illness.
Participants in the medication-only control group will continue to receive their usual pharmacological management for chronic migraine and will not receive the structured psychological interventions provided in the CBT and TIIP groups.
Outcomes will be assessed using standardized measures of migraine-related disability, headache management self-efficacy, depression, anxiety and stress, and quality of life. The primary purpose of the study is to determine whether CBT and TIIP produce improvements in these outcomes and whether TIIP demonstrates comparable or greater efficacy than CBT and medication-only treatment.
The findings of this study may contribute to the development of culturally and spiritually appropriate psychological interventions for chronic migraine and provide evidence regarding the potential role of integrated Islamic psychotherapy as an adjunctive approach to migraine management.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged between 18 and 40 years, the band Chen et al. (2024) identify as carrying the heaviest global burden of migraine prevalence and disability.
Exclusion Criteria:
Aged below 18 or above 40 years.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy (CBT) · Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP) · Other: Medication Group
Traditional Integrated Islamic Psychotherapy
Behavioral: Cognitive Behavioral Therapy (CBT) · Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP) · Other: Medication Group
Medication/Usual Care
Behavioral: Cognitive Behavioral Therapy (CBT) · Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP) · Other: Medication Group
A structured six-week Cognitive Behavioral Therapy intervention consisting of weekly 45-60 minute sessions for participants with chronic migraine. The intervention targets maladaptive thoughts, emotional distress, stress management, coping strategies, behavioral responses to migraine, and self-management skills. The intervention is designed to reduce migraine-related disability and improve psychological well-being, headache self-efficacy, and quality of life.
A structured six-week Traditional Integrated Islamic Psychotherapy intervention consisting of weekly 45-60 minute sessions for participants with chronic migraine. The intervention integrates Islamic psychological and spiritual principles, including Tawheed, Fitrah, Qalb, Aql, Nafs, Tazkiyah, Qur'anic reflection, and coping strategies, with particular use of Surah Al-Rahman. The intervention aims to promote psychological and spiritual well-being, improve coping and headache self-efficacy, reduce psychological distress, and improve migraine-related quality of life.
Only pre and post will be taken of 15 participants to compare CBT and TIIP results
Migraine-Related Disability as Measured by the Migraine Disability Assessment (MIDAS)
Change in migraine-related disability from baseline to post-intervention, assessed using the Migraine Disability Assessment (MIDAS). Lower MIDAS scores indicate less migraine-related disability. The outcome will be compared across the Traditional Integrated Islamic Psychotherapy (TIIP), Cognitive Behavioral Therapy (CBT), and medication-only groups.
Time frame: Baseline and immediately after completion of the 6-week interventio
DASS 21
Change in symptoms of depression, anxiety, and stress from baseline to post-intervention, assessed using the Depression Anxiety Stress Scale-21 (DASS-21). The three subscale scores will be examined separately to determine changes in depression, anxiety, and stress symptoms across the TIIP, CBT, and medication-only groups.
Time frame: Baseline and immediately after completion of the 6-week intervention
Headache Management Self-Efficacy Scale (HMSE)
a 25-item self-report questionnaire designed to measure an individual's confidence in their ability to prevent headache episodes and manage head pain
Time frame: Baseline and immediately after completion of the 6-week interventio
WHO-QOL BREF
a 26-question survey made by the World Health Organization. It measures a person's physical health, mind, social life, and living place to check their overall quality of life.
Time frame: Baseline and immediately after completion of the 6-week intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Jun 2026, 15 months.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 15 months is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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GIFT University