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

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.