Clinical trial NCT03701477: Trans-diagnostic Cognitive-behavioral Therapy for Treatment of Migraine
Official title: Evaluation of the Efficacy of Trans-diagnostic Cognitive-behavioral Therapy on Controlling and Reducing Headache and Associated Symptoms Among Migrainous Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
trans-diagnostic approach
headache
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control and intervention arms
Primary purpose: TREATMENT

Brief summary: Migraine headache is one of the disabling conditions that may be associated with decreased quality of life, anxiety and depression. Currently, therapeutic approach to migraine is mostly based on prophylactic and acute phase medication therapy. Some investigators consider migraine a biopsychosocial condition which means that psychological therapies, such as cognitive-behavioral therapy and relaxation, may be efficient in controlling the disease. According to previous studies, cognitive therapies, including cognitive-behavioral therapy, have been efficient in decreasing frequency and severity of migraine, however, there are some challenges in applying these kind of interventions: the expenses; presence of multiple commodities that may lead to confusion and bewilderment for both therapist and patient; small number of trained psychologists for this intervention.

The trans-diagnostic approach, however, can facilitate some challenges with the previous method. Since it is not focused on a single condition, trained psychologists with this approach can apply it for a wide range of conditions, including migraine. Also, the trans-diagnostic approach leads to lower chances of confusion and bewilderment for therapist and patients. The trans-diagnostic approach focuses on therapeutic modules instead of constant similar therapeutic models. The five cores of trans-diagnostic approach are emotional awareness, cognitive flexibility, recognizing and preventing emotion avoidance and maladaptive emotion driven behaviors, awareness and tolerance of emotion-related physical conditions, and introceptive and situation-based emotion-focused exposure. This method was first designed to replace cognitive-behavioral therapy for emotional disorders, due to its feasibility and applicability.

The trans-diagnostic approach has been investigated by several researchers so far, however, most of those researches evaluate the efficacy of the technique on psychiatric disorders. It has also been investigated for treatment of headaches in adolescents. But no other study on other clinical problems or migraine has been conducted. Considering the high rates of comorbid anxiety and depressive symptoms in migrainous patients and the feasibility and efficacy of trans-diagnostic cognitive-behavioral therapy in other conditions, we aimed to evaluate its efficacy on controlling headache and related symptoms among migrainous patients.

Detailed description: Migraine headache is one of the disabling conditions that occurs more in young women. It is usually associated with decreased quality of life, as well as anxiety and depressed in the affected individuals. Currently, therapeutic approach to migraine is mostly based on medication therapy in two phases of prophylaxis and acute attacks. However, some investigators consider it not only as a biologic disease, but also a multidimensional condition that may be accompanied by anxiety and depressive symptoms. Considering migraine as a biopsychosocial condition means that psychological therapies, such as cognitive-behavioral therapy and relaxation, may be efficient in controlling the disease. According to previous studies, cognitive therapies, including cognitive-behavioral therapy, have been efficient in decreasing frequency and severity of migraine, however, there are some challenges in applying these kind of interventions for patients: the costs of such treatments are usually not covered by insurance companies; presence of multiple commodities may lead to confusion and bewilderment for both therapist and patient while applying the technique; training psychologists for this intervention is costly and not enough psychologists know how to handle the condition.

The trans-diagnostic approach, however, can facilitate some challenges with the previous method. Since it is not focused on a single condition, trained psychologists with this approach can apply it for a wide range of conditions, including migraine. Also, the trans-diagnostic approach leads to lower chances of confusion and bewilderment for therapist and patients.

The trans-diagnostic approach is somehow similar to the classic cognitive-behavioral therapy. however, it focuses on therapeutic modules instead of constant similar therapeutic models. The five cores of trans-diagnostic approach are emotional awareness, cognitive flexibility, recognizing and preventing emotion avoidance and maladaptive emotion driven behaviors, awareness and tolerance of emotion-related physical conditions, and introceptive and situation-based emotion-focused exposure. This method was first designed to replace cognitive-behavioral therapy for emotional disorders, due to its feasibility and applicability.

The trans-diagnostic approach has been investigated by several researchers so far, however, most of those researches evaluate the efficacy of the technique on psychiatric disorders. It has also been investigated for treatment of headaches in adolescents. But no other study on other clinical problems or migraine has been conducted. Considering the high rates of comorbid anxiety and depressive symptoms in migrainous patients and the feasibility and efficacy of trans-diagnostic cognitive-behavioral therapy in other conditions, we aimed to evaluate its efficacy on controlling headache and related symptoms among migrainous patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of migraine headache by primary neurologist based on the criteria defined by International Classification of Headache Disorders III Beta (ICHD-III Beta).
* Diagnosed with migraine at least 6 months prior to enrollment
* High school graduate or higher level of education

Exclusion Criteria:

* Medication overuse based on the criteria defined by ICHD-III Beta (taking non-steroidal anti-inflammatory drugs or other pain relievers at least 15 days in each month; taking triptans or similar drugs at least 10 days each month for 3 months or more)
* Addition of no new prophylactic migraine medication during the study
* suffering from other types of headache disorders
* Being treated with other psychological therapies (psychotherapy, ...) during the study.
* Not being able to fill our self-administered questionnaires (illiteracy, cognitive problems)
* Altered cognitive or mental status, like dementia

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Before intervention; one month after the intervention
measure: Headache Impact Test-6 (HIT-6)
timeFrame: Before intervention; one month after the intervention
measure: Migraine Disability Assessment Scale (MIDAS)
timeFrame: Before intervention; one month after the intervention
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Before intervention; one month after the intervention
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Before intervention; Immediately after the intervention
measure: Headache Impact Test-6 (HIT-6)
timeFrame: Before intervention; Immediately after the intervention
measure: Migraine Disability Assessment Scale (MIDAS)
timeFrame: Before intervention; Immediately after the intervention
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Before intervention; Immediately after the intervention
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Shokooh counselling center
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Vahid Shaygannejad, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Soleimanian-Boroujeni F, Badihian N, Badihian S, Shaygannejad V, Gorji Y. The efficacy of transdiagnostic cognitive behavioral therapy on migraine headache: a pilot, feasibility study. BMC Neurol. 2022 Jun 22;22(1):230. doi: 10.1186/s12883-022-02729-8.