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

NCT07802912 | Completed

• 1 other identifier: 24101830043@gift.edu.pk
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Migraine Headache

Keywords

CBT TIIP Chronic Migraine Surah Rehman

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and immediately after completion of the 6-week interventio

Secondary Outcomes (3)

• DASS 21

  Baseline and immediately after completion of the 6-week intervention

• Headache Management Self-Efficacy Scale (HMSE)

  Baseline and immediately after completion of the 6-week interventio

• WHO-QOL BREF

  Baseline and immediately after completion of the 6-week intervention

Study Arms (3)

CBT Group

EXPERIMENTAL

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP); Other: Medication Group

TIIP

EXPERIMENTAL

Traditional Integrated Islamic Psychotherapy

Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP); Other: Medication Group

Medication-Only Control Group

ACTIVE COMPARATOR

Medication/Usual Care

Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Traditional Integrated Islamic Psychotherapy (TIIP); Other: Medication Group

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.

CBT Group; Medication-Only Control Group; TIIP

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.

CBT Group; Medication-Only Control Group; TIIP

Medication Group OTHER

Only pre and post will be taken of 15 participants to compare CBT and TIIP results

CBT Group; Medication-Only Control Group; TIIP

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• GIFT University: lead

Study Sites (1)

GIFT University

Gujranwala, Punjab Province, 52250, Pakistan

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ather Mujitaba, pHD in Clincal Psychology

  Assistant Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: March 10, 2025
• Primary Completion: June 20, 2026
• Study Completion: July 20, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)