Chronic Migraine HeadacheCBT TIIPNCT07802912
Efficacy of Traditional Integrated Islamic Psychotherapy and Cognitive Behavioural Therapy for Migraine: A Randomized Controlled Trial
A study testing Cognitive Behavioral Therapy (CBT), Traditional Integrated Islamic Psychotherapy (TIIP) and Medication Group in people with Chronic Migraine Headache, run by GIFT University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Chronic Migraine Headache
- What is being tested?
- Cognitive Behavioral Therapy (CBT), Traditional Integrated Islamic Psychotherapy (TIIP) and Medication Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2025to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 40 years, the band Chen et al. (2024) identify as carrying the heaviest global burden of migraine prevalence and disability.
- A neurologist's diagnosis of chronic migraine established in accordance with International Headache Society criteria.
- A MIDAS total of 21 or above, so that participants carried a clinically meaningful level of impairment and had room to improve (Stewart et al., 2001).
- A score in the mild to moderate band on at least one DASS-21 subscale, since the study concerned migraine-associated distress rather than primary psychiatric disorder (Lovibond \& Lovibond, 1995).
- A stable prophylactic medication regimen for at least one month before enrolment, with no change planned during the study, so that any shift in outcome could not be laid at the door of a change in drugs.
- Both men and women were eligible, so that the sample resembled the clinical population rather than one gender.
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- At least primary-level education, sufficient to read and complete the self-report instruments independently.
- Enough Urdu or English to engage with the intervention material.
- Willingness to give written informed consent and to commit to the full schedule of six weekly sessions and both assessment appointments.
- Residence in Gujranwala for the duration of the study and reachable by telephone, so that attendance could be monitored and attrition kept down.
- Not receiving any other form of psychotherapy at enrolment, so that the effect of the study interventions could be isolated.
Who cannot join
- Aged below 18 or above 40 years.
- A diagnosed severe psychiatric disorder, including psychotic disorder, bipolar disorder, or severe major depressive disorder with active suicidality.
- A score in the severe or extremely severe range on any DASS-21 subscale, or any indication of suicidal thinking.
- A current need for intensive or immediate psychiatric treatment.
- A substance use disorder within the preceding six months. Substance use and withdrawal are themselves recognised causes of headache under the International Classification of Headache Disorders (Headache Classification Committee of the International Headache Society, 2018) and independently raise scores on measures of depression, anxiety, and stress, so their inclusion would have confounded both the primary and the secondary outcomes. Six months was adopted because it maps onto the early remission specifier of the DSM-5-TR, under which someone who has met no criterion for a substance use disorder for at least three months but less than twelve is classified as in early remission (American Psychiatric Association, 2022), making it a recognised diagnostic boundary rather than an arbitrary line.
- A neurological disorder other than migraine, such as epilepsy, brain tumour, or multiple sclerosis.
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- A serious medical condition likely to interfere with participation or to confound the outcomes.
- Concurrent psychotherapy or enrolment in another intervention study.
- Inability to give informed consent or to comply with the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Migraine Headache
- Being tested
- Cognitive Behavioral Therapy (CBT), Traditional Integrated Islamic Psychotherapy (TIIP), Medication Group
- Keywords
- CBT TIIP Chronic Migraine Surah Rehman
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
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.
Traditional Integrated Islamic Psychotherapy (TIIP)Behavioural
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.
Medication GroupOther
Only pre and post will be taken of 15 participants to compare CBT and TIIP results
| Study group | Role | What they receive |
|---|---|---|
| CBT Group | Experimental | Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP); Other: Medication Group |
| TIIP | Experimental | Traditional Integrated Islamic Psychotherapy Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP); Other: Medication Group |
| Medication-Only Control Group | Active comparator | Medication/Usual Care Receives: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP); Other: Medication Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after completion of the 6-week interventio
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Baseline and immediately after completion of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start10 Mar 2025
- Primary completion20 Jun 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- GIFT University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Qamar, GIFT University
- Investigators
- Ather Mujitaba, pHD in Clincal Psychology, Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802912
- Sponsor's protocol ID
- 24101830043@gift.edu.pk
- Acronym
- CBT TIIP
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Traditional Integrated Islamic Psychotherapy and Cognitive Behavioural Therapy for Migraine: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07802912
- Acronym / sponsor ID
- CBT TIIP / 24101830043@gift.edu.pk
- Conditions
- Chronic Migraine Headache
- Keywords
- CBT TIIP Chronic Migraine Surah Rehman
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GIFT UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT Group | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP), Other: Medication GroupCognitive Behavioral Therapy |
| TIIP | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP), Other: Medication GroupTraditional Integrated Islamic Psychotherapy |
| Medication-Only Control Group | Active comparator | Behavioral: Cognitive Behavioral Therapy (CBT), Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP), Other: Medication GroupMedication/Usual Care |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Aged between 18 and 40 years, the band Chen et al. (2024) identify as carrying the heaviest global burden of migraine prevalence and disability.
Key exclusion criteria (9 listed)
- Aged below 18 or above 40 years.
- A diagnosed severe psychiatric disorder, including psychotic disorder, bipolar disorder, or severe major depressive disorder with active suicidality.
- A score in the severe or extremely severe range on any DASS-21 subscale, or any indication of suicidal thinking.
- A current need for intensive or immediate psychiatric treatment.
- A substance use disorder within the preceding six months. Substance use and withdrawal are themselves recognised causes of headache under the International Classification of Headache Disorders (Headache Classification Committee of the International Headache Society, 2018) and independently raise scores on measures of depression, anxiety, and stress, so their inclusion would have confounded both the primary and the secondary outcomes. Six months was adopted because it maps onto the early remission specifier of the DSM-5-TR, under which someone who has met no criterion for a substance use disorder for at least three months but less than twelve is classified as in early remission (American Psychiatric Association, 2022), making it a recognised diagnostic boundary rather than an arbitrary line.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)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. | Behavioural | CBT Group, Medication-Only Control Group, TIIP |
| Traditional Integrated Islamic Psychotherapy (TIIP)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. | Behavioural | CBT Group, Medication-Only Control Group, TIIP |
| Medication GroupOnly pre and post will be taken of 15 participants to compare CBT and TIIP results | Other | CBT Group, Medication-Only Control Group, TIIP |
Primary outcome
Migraine-Related Disability as Measured by the Migraine Disability Assessment (MIDAS)
Time frame: Baseline and immediately after completion of the 6-week interventio
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.
3 secondary outcomes
DASS 21
Time frame: Baseline and immediately after completion of the 6-week intervention
Headache Management Self-Efficacy Scale (HMSE)
Time frame: Baseline and immediately after completion of the 6-week interventio
WHO-QOL BREF
Time frame: Baseline and immediately after completion of the 6-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ather Mujitaba, pHD in Clincal Psychology study director
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT), Traditional Integrated Islamic Psychotherapy (TIIP) and Medication Group in people with Chronic Migraine Headache, run by GIFT University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine-Related Disability as Measured by the Migraine Disability Assessment (MIDAS) (time frame: Baseline and immediately after completion of the 6-week interventio). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.