Trans-diagnostic Cognitive-behavioral Therapy for Treatment of Migraine

October 8, 2018 updated by: Vahid Shaygannejad, Isfahan University of Medical Sciences

Evaluation of the Efficacy of Trans-diagnostic Cognitive-behavioral Therapy on Controlling and Reducing Headache and Associated Symptoms Among Migrainous Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trans-diagnostic approach
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.
Behavioral: Trans-diagnostic cognitive-behavioral therapy
10 therapeutic sessions hold in groups of 5-10 individuals. Details about each session: Session 1: Establishing rapport, psychoeducation; Session 2: Relaxation, hierarchy development; Session 3: Identifying automatic negative thoughts, guided imaginary; Session 4: Cognitive restructuring; Session 5: Problem solving skills training, distraction; Session 6: Exposure-based procedures, cognitive restructuring; Session 7-9: Advanced cognitive restructuring, stress management, assertiveness skills training, preparation for termination phase; Session 10: Relapse prevention, termination
SHAM_COMPARATOR: Control
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.
Behavioral: General relaxation/stress management therapeutic session
Patients will attend a 3-hour meeting in which basic techniques of relaxation and stress management will be discussed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Before intervention; one month after the intervention
Visual analog scale is used to rate the severity of headaches in patients. Patients are supposed to rate their pain on a scale from 0 to 10, 10 means the worst pain and 0 means no pain. They also can see cartoon faces that illustrate the severity of pain along with the numbers. Basically, lower numbers from this scale indicate better outcome. The scale has no sub-scale or other interpretation and the scores rated by patients will be described as the results.
Before intervention; one month after the intervention
Headache Impact Test-6 (HIT-6)
Time Frame: Before intervention; one month after the intervention
This standard questionnaire evaluates the impact of headache on patient's ability to function on the job, at school, at home, or in social situations. It contains 6 questions (5-point Likert scale), each question covering one aspect of headache impact. The choices for each question can be never, rarely, sometimes, often, and always. These choices are rated as 6, 8, 10, 11, and 13 points, respectively, and the sum of scores shows the total score. The total score ranges from 36 (lowest score, the favorable outcome) to 78 (worst outcome, debilitating headaches). Also, scores higher than 50 mean that headache had caused significant disability for the patient. This questionnaire has no subscale and total scores will be reported.
Before intervention; one month after the intervention
Migraine Disability Assessment Scale (MIDAS)
Time Frame: Before intervention; one month after the intervention
This standard questionnaire collects the days of disability due to headache. This questionnaire includes 5 questions, each question asking for number of the days that has caused a certain disability. The answers for these questions will be summed up to find the total score of the questionnaire. Based on the total score, the patient will be categorized in one of these groups: score 0-5 means no/unremarkable disability; score 6-10 means mild disability; score 11-20 means moderate disability; score>21 mean severe disability. As it was described, higher scores show worst outcome and lower scores present favorable outcome.
Before intervention; one month after the intervention
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Before intervention; one month after the intervention
This questionnaire evaluates general status of patient with respect to anxiety and depressive symptoms. The questionnaire contains 14 questions, 7 evaluate depression and 7 evaluate anxiety. Therefore, it has two subscales. Questions are 4-point Liker scales. Each question is scored from 0 to 3 based on the patient's choice, which is defined for each question. At the end, scores in each subscale are summed up to reach the total score on that subscale. In both subscales, score 0-7 means normal status, 8-10 means borderline status, and 11-21 means abnormal status on that subscale. As it was described, higher scores show worst outcome. The total score of the questionnaire won't be reported separately.
Before intervention; one month after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Before intervention; Immediately after the intervention
Visual analog scale is used to rate the severity of headaches in patients. Patients are supposed to rate their pain on a scale from 0 to 10, 10 means the worst pain and 0 means no pain. They also can see cartoon faces that illustrate the severity of pain along with the numbers. Basically, lower numbers from this scale indicate better outcome. The scale has no sub-scale or other interpretation and the scores rated by patients will be described as the results.
Before intervention; Immediately after the intervention
Headache Impact Test-6 (HIT-6)
Time Frame: Before intervention; Immediately after the intervention
This standard questionnaire evaluates the impact of headache on patient's ability to function on the job, at school, at home, or in social situations. It contains 6 questions (5-point Likert scale), each question covering one aspect of headache impact. The choices for each question can be never, rarely, sometimes, often, and always. These choices are rated as 6, 8, 10, 11, and 13 points, respectively, and the sum of scores shows the total score. The total score ranges from 36 (lowest score, the favorable outcome) to 78 (worst outcome, debilitating headaches). Also, scores higher than 50 mean that headache had caused significant disability for the patient. This questionnaire has no subscale and total scores will be reported.
Before intervention; Immediately after the intervention
Migraine Disability Assessment Scale (MIDAS)
Time Frame: Before intervention; Immediately after the intervention
This standard questionnaire collects the days of disability due to headache. This questionnaire includes 5 questions, each question asking for number of the days that has caused a certain disability. The answers for these questions will be summed up to find the total score of the questionnaire. Based on the total score, the patient will be categorized in one of these groups: score 0-5 means no/unremarkable disability; score 6-10 means mild disability; score 11-20 means moderate disability; score>21 mean severe disability. As it was described, higher scores show worst outcome and lower scores present favorable outcome.
Before intervention; Immediately after the intervention
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Before intervention; Immediately after the intervention
This questionnaire evaluates general status of patient with respect to anxiety and depressive symptoms. The questionnaire contains 14 questions, 7 evaluate depression and 7 evaluate anxiety. Therefore, it has two subscales. Questions are 4-point Liker scales. Each question is scored from 0 to 3 based on the patient's choice, which is defined for each question. At the end, scores in each subscale are summed up to reach the total score on that subscale. In both subscales, score 0-7 means normal status, 8-10 means borderline status, and 11-21 means abnormal status on that subscale. As it was described, higher scores show worst outcome. The total score of the questionnaire won't be reported separately.
Before intervention; Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: Vahid Shaygannejad, MD, Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 8, 2018

First Posted (ACTUAL)

October 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18820701962055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

anonymized data will be made available upon request from researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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