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Trans-diagnostic Cognitive-behavioral Therapy for Treatment of Migraine

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ClinicalTrials.gov Identifier: NCT03701477
Recruitment Status : Not yet recruiting
First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Vahid Shaygannejad, Isfahan University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Migraine Behavioral: Trans-diagnostic cognitive-behavioral therapy Behavioral: General relaxation/stress management therapeutic session Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: control and intervention arms
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The primary investigator and outcomes assessors will be masked. The care provider and participants won't be masked.
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Trans-diagnostic Cognitive-behavioral Therapy on Controlling and Reducing Headache and Associated Symptoms Among Migrainous Patients
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701477


Contacts
Contact: Shervin Badihian, MD 4436270398 shervin.badihian@gmail.com
Contact: Vahid Shaygannejad, MD +989133133550 shaygannejad@med.mui.ac.ir

Locations
Iran, Islamic Republic of
Shoko0h counselling center Not yet recruiting
Isfahan, Iran, Islamic Republic of, 8173888693
Contact: Forouzandeh Soleimanian Boroujeni, MS    +989131102113    forouzsol36@gmail.com   
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Vahid Shaygannejad, MD Isfahan University of Medical Sciences

Publications of Results:

Responsible Party: Vahid Shaygannejad, Professor of Neurology, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03701477     History of Changes
Other Study ID Numbers: 18820701962055
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: anonymized data will be made available upon request from researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vahid Shaygannejad, Isfahan University of Medical Sciences:
Migraine
trans-diagnostic approach
headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases