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Trans-diagnostic Cognitive-behavioral Therapy for Treatment of Migraine

I

Isfahan University of Medical Sciences

Status

Completed

Conditions

Migraine

Treatments

Behavioral: General relaxation/stress management therapeutic session
Behavioral: Trans-diagnostic cognitive-behavioral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03701477
18820701962055

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Trans-diagnostic approach
Experimental group
Description:
Trans-diagnostic cognitive-behavioral therapy In this arm, patients will participate in 10 sessions of therapy. During each session, specific topics will be discussed and participants will need to complete their homework for the next session. Each session lasts for 120 minutes. Sessions will be held in groups of 5-10 subjects weekly, except the last session that will be held after a two-week interval.
Treatment:
Behavioral: Trans-diagnostic cognitive-behavioral therapy
Control
Sham Comparator group
Description:
General relaxation/stress management therapeutic session In this arm, patients will attend a 3-hour meeting in which basic techniques of relaxation and overcoming stress and anxiety will be discussed.
Treatment:
Behavioral: General relaxation/stress management therapeutic session

Trial contacts and locations

1

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Central trial contact

Vahid Shaygannejad, MD; Shervin Badihian, MD

Data sourced from clinicaltrials.gov

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