MigraineNCT03701477
Trans-diagnostic Cognitive-behavioral Therapy for Treatment of Migraine
A study testing Trans-diagnostic cognitive-behavioral therapy and General relaxation/stress management therapeutic session in people with Migraine, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Migraine
- What is being tested?
- Trans-diagnostic cognitive-behavioral therapy and General relaxation/stress management therapeutic session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Trans-diagnostic cognitive-behavioral therapy, General relaxation/stress management therapeutic session
- Keywords
- Migraine, trans-diagnostic approach, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-diagnostic cognitive-behavioral therapyBehavioural
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
General relaxation/stress management therapeutic sessionBehavioural
Patients will attend a 3-hour meeting in which basic techniques of relaxation and stress management will be discussed.
| Study group | Role | What they receive |
|---|---|---|
| Trans-diagnostic approach | Experimental | 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. Receives: Behavioral: Trans-diagnostic cognitive-behavioral therapy |
| Control | Sham comparator | 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. Receives: Behavioral: General relaxation/stress management therapeutic session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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.
Measured: Before intervention; one month after the intervention
Headache Impact Test-6 (HIT-6)
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.
Measured: Before intervention; one month after the intervention
Migraine Disability Assessment Scale (MIDAS)
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.
Measured: Before intervention; one month after the intervention
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Before intervention; one month after the intervention
Secondary outcomes (4)
Visual Analog Scale
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.
Measured: Before intervention; Immediately after the intervention
Headache Impact Test-6 (HIT-6)
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.
Measured: Before intervention; Immediately after the intervention
Migraine Disability Assessment Scale (MIDAS)
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.
Measured: Before intervention; Immediately after the intervention
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Before intervention; Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Oct 2018
- Primary completion30 Apr 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control and intervention arms
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vahid Shaygannejad, Isfahan University of Medical Sciences
- Investigators
- Vahid Shaygannejad, MD, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701477
- Sponsor's protocol ID
- 18820701962055
- Status last verified
- May 2024
- First submitted
- 2 Oct 2018
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymized data will be made available upon request from researchers.
Publications
Allen LB, Tsao JCI, Seidman LC, Ehrenreich-May J, Zeltzer LK. A Unified, Transdiagnostic Treatment for Adolescents With Chronic Pain and Comorbid Anxiety and Depression. Cogn Behav Pract. 2012 Feb;19(1):56-67. doi: 10.1016/j.cbpra.2011.04.007.
PubMed 28824271Bullis JR, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Carl JR, Barlow DH. The unified protocol for transdiagnostic treatment of emotional disorders: preliminary exploration of effectiveness for group delivery. Behav Modif. 2015 Mar;39(2):295-321. doi: 10.1177/0145445514553094. Epub 2014 Oct 14.
PubMed 25316034Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009 May;84(5):422-35. doi: 10.1016/S0025-6196(11)60561-2.
PubMed 19411439D'Amico D, Leonardi M, Grazzi L, Curone M, Raggi A. Disability and quality of life in patients with different forms of migraine. J Headache Pain. 2015 Dec;16(Suppl 1):A4. doi: 10.1186/1129-2377-16-S1-A4. No abstract available.
PubMed 28132384Harris P, Loveman E, Clegg A, Easton S, Berry N. Systematic review of cognitive behavioural therapy for the management of headaches and migraines in adults. Br J Pain. 2015 Nov;9(4):213-24. doi: 10.1177/2049463715578291.
PubMed 26526604Myhr G, Payne K. Cost-effectiveness of cognitive-behavioural therapy for mental disorders: implications for public health care funding policy in Canada. Can J Psychiatry. 2006 Sep;51(10):662-70. doi: 10.1177/070674370605101006.
PubMed 17052034Norton PJ, Barrera TL. Transdiagnostic versus diagnosis-specific cbt for anxiety disorders: a preliminary randomized controlled noninferiority trial. Depress Anxiety. 2012 Oct;29(10):874-82. doi: 10.1002/da.21974. Epub 2012 Jul 5.
PubMed 22767410Singer AB, Buse DC, Seng EK. Behavioral treatments for migraine management: useful at each step of migraine care. Curr Neurol Neurosci Rep. 2015 Apr;15(4):14. doi: 10.1007/s11910-015-0533-5.
PubMed 25708673Sullivan A, Cousins S, Ridsdale L. Psychological interventions for migraine: a systematic review. J Neurol. 2016 Dec;263(12):2369-2377. doi: 10.1007/s00415-016-8126-z. Epub 2016 May 9.
PubMed 27159991Soleimanian-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.
PubMed 35733127
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Trans-diagnostic Cognitive-behavioral Therapy on Controlling and Reducing Headache and Associated Symptoms Among Migrainous Patients
- ClinicalTrials.gov ID
- NCT03701477
- Acronym / sponsor ID
- 18820701962055
- Conditions
- Migraine
- Keywords
- Migraine, trans-diagnostic approach, headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- control and intervention arms
| Arm | Type | Receives |
|---|---|---|
| Trans-diagnostic approach | Experimental | Behavioral: Trans-diagnostic cognitive-behavioral therapyTrans-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. |
| Control | Sham comparator | Behavioral: General relaxation/stress management therapeutic sessionGeneral 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-diagnostic cognitive-behavioral therapy10 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 | Behavioural | Trans-diagnostic approach |
| General relaxation/stress management therapeutic sessionPatients will attend a 3-hour meeting in which basic techniques of relaxation and stress management will be discussed. | Behavioural | Control |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Visual Analog Scale
Time frame: Before intervention; Immediately after the intervention
Headache Impact Test-6 (HIT-6)
Time frame: Before intervention; Immediately after the intervention
Migraine Disability Assessment Scale (MIDAS)
Time frame: Before intervention; Immediately after the intervention
Hospital Anxiety and Depression Scale (HADS)
Time frame: Before intervention; Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Results publication: PubMed 28824271Allen LB, Tsao JCI, Seidman LC, Ehrenreich-May J, Zeltzer LK. A Unified, Transdiagnostic Treatment for Adolescents With Chronic Pain and Comorbid Anxiety and Depression. Cogn Behav Pract. 2012 Feb;19(1):56-67. doi: 10.1016/j.cbpra.2011.04.007.
- Results publication: PubMed 25316034Bullis JR, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Carl JR, Barlow DH. The unified protocol for transdiagnostic treatment of emotional disorders: preliminary exploration of effectiveness for group delivery. Behav Modif. 2015 Mar;39(2):295-321. doi: 10.1177/0145445514553094. Epub 2014 Oct 14.
- Results publication: PubMed 19411439Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009 May;84(5):422-35. doi: 10.1016/S0025-6196(11)60561-2.
- Results publication: PubMed 28132384D'Amico D, Leonardi M, Grazzi L, Curone M, Raggi A. Disability and quality of life in patients with different forms of migraine. J Headache Pain. 2015 Dec;16(Suppl 1):A4. doi: 10.1186/1129-2377-16-S1-A4. No abstract available.
- Results publication: PubMed 26526604Harris P, Loveman E, Clegg A, Easton S, Berry N. Systematic review of cognitive behavioural therapy for the management of headaches and migraines in adults. Br J Pain. 2015 Nov;9(4):213-24. doi: 10.1177/2049463715578291.
- Results publication: PubMed 17052034Myhr G, Payne K. Cost-effectiveness of cognitive-behavioural therapy for mental disorders: implications for public health care funding policy in Canada. Can J Psychiatry. 2006 Sep;51(10):662-70. doi: 10.1177/070674370605101006.
- Results publication: PubMed 22767410Norton PJ, Barrera TL. Transdiagnostic versus diagnosis-specific cbt for anxiety disorders: a preliminary randomized controlled noninferiority trial. Depress Anxiety. 2012 Oct;29(10):874-82. doi: 10.1002/da.21974. Epub 2012 Jul 5.
- Results publication: PubMed 25708673Singer AB, Buse DC, Seng EK. Behavioral treatments for migraine management: useful at each step of migraine care. Curr Neurol Neurosci Rep. 2015 Apr;15(4):14. doi: 10.1007/s11910-015-0533-5.
- Results publication: PubMed 27159991Sullivan A, Cousins S, Ridsdale L. Psychological interventions for migraine: a systematic review. J Neurol. 2016 Dec;263(12):2369-2377. doi: 10.1007/s00415-016-8126-z. Epub 2016 May 9.
- Derived from this study: PubMed 35733127Soleimanian-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.
- Individual participant dataSharing planned: Undecided. anonymized data will be made available upon request from researchers.
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Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vahid Shaygannejad, MD principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-diagnostic cognitive-behavioral therapy and General relaxation/stress management therapeutic session in people with Migraine, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Before intervention; one month after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701477, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.