Efficacy of Traditional Integrated Islamic Psychotherapy and Cognitive Behavioural Therapy for Migraine: A Randomized Controlled Trial

GIFT University45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Chronic Migraine Headache

Interventions

Cognitive Behavioral Therapy (CBT)BEHAVIORAL

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)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * 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. Exclusion Criteria: 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. * 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.

Locations (1)

GIFT University

Gujranwala, Punjab Province, Pakistan

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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