A Study the effectiveness of mindfulness-based stress reduction treatment on anxiety sensitivity, rumination, cognitive avoidance and emotional resilience in women with neurogenic migraine
Study of the effectiveness of mindfulness-based stress reduction therapy on anxiety sensitivity, rumination, cognitive avoidance, and emotional resilience in women with migraine
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 40 patients. SPSS/27 was used for randomization.
Settings and conduct
In this study, in order to select a representative sample of women with migraine neurosis living in Ahvaz, a stratified random sampling method with proportional allocation was used. The sampling unit in this study was the patient (a woman with migraine neurosis). Using this method allows for examining possible differences between different groups of patients and reducing sampling error.
Participants/Inclusion and exclusion criteria
Research entry criteria:
1- Age range 20 to 50 years for women with migraine 2- Signing a written consent form to participate in the research and adhere to treatment
Research exit criteria:
1- Simultaneous participation in other psychological treatments 2- Having diseases such as substance abuse and psychotic disorder
Intervention groups
Mindfulness-Based Stress Reduction: This training session was developed based on the Kabat-Zinn method (2013) and is conducted in 8 90-minute sessions, two sessions per week for 1 month.
Main outcome variables
Mindfulness-based stress reduction in women with migraine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250624066248N1
Registration date:2025-09-08, 1404/06/17
Registration timing:retrospective
Last update:2025-09-08, 1404/06/17
Update count:0
Registration date
2025-09-08, 1404/06/17
Registrant information
Name
Akram Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5262 2200
Email address
akramhosseiny67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-08, 1403/11/20
Expected recruitment end date
2025-03-10, 1403/12/20
Actual recruitment start date
2025-02-08, 1403/11/20
Actual recruitment end date
2025-03-10, 1403/12/20
Trial completion date
2025-08-11, 1404/05/20
Scientific title
A Study the effectiveness of mindfulness-based stress reduction treatment on anxiety sensitivity, rumination, cognitive avoidance and emotional resilience in women with neurogenic migraine
Public title
Mindfulness-based stress reduction treatment for women with migraine headaches.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of women with migraines: 20 to 50 years
History of headaches for at least the past 6 months
Exclusion criteria:
Concurrent participation in other psychological treatments
Having illnesses such as substance abuse and psychotic disorder
Unwillingness to participate in research
Age
From 20 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participant allocation to study groups was performed using block randomization. The block size was set at block size, 4 participants. To ensure a balanced distribution of participants based on [key characteristic, e.g., migraine severity], stratified randomization was also employed. The unit of randomization was individual. The allocation sequence was generated using statistical software SPSS , and the allocation process was concealed via [concealment method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Ahvaz Branch
Street address
Golestan-Islamic Azad University of Ahvaz
City
AHVAZ
Province
Khouzestan
Postal code
134937333
Approval date
2025-01-15, 1403/10/26
Ethics committee reference number
IR.IAU.AHVAZ.REC.1403.457
Health conditions studied
1
Description of health condition studied
Nervous migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura
Primary outcomes
1
Description
Mindfulness-based stress reduction in women with migraine.
Timepoint
30
Method of measurement
Kabat-Zinn Method (2013)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mindfulness-Based Stress Reduction Therapy: In this method, with a psychological understanding, the mind-body medicine models of stress are integrated with findings related to how to cope with the challenges of modern life. Therefore, this program includes intensive mindfulness meditation training and participants are trained to apply what they have learned practically in relation to the problems of managing the challenges of daily life. In this design, the subjects were measured before the implementation of the independent variable (pre-test), then the experimental intervention or independent variable was applied. After that, the subjects were measured again. Finally, after one month of the post-test, both groups were measured again to examine the continuity of the effects of the interventions on the experimental group. In the present study, mindfulness-based stress reduction training sessions were implemented based on the Kabat-Zinn protocol (2013) and were implemented over an 8-week period with 90-minute sessions per week for the experimental group.
Category
Treatment - Other
2
Description
Control group: The control group did not receive any intervention during the study. However, to avoid factors that threatened the internal validity of the study, such as compensatory competition by the control group or demoralization, they were assured that they would receive mindfulness-based stress reduction therapy at the next visit (after data collection).