Determining the effectiveness of acceptance and commitment therapy on emotional resilience, cognitive avoidance, and rumination in women with migraine.
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 40 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
The statistical population of the present study will include all female patients with migraine who refer to neurologists at Shafa Hospital in Ahvaz during the specified time period of the study. Purposive sampling method will be used to select the sample. In this way, by referring to the neurology department of Shafa Hospital and obtaining permission from the relevant doctors, a list of patients with migraine will be received. After selecting the samples to a volume of 40 people, based on the inclusion and exclusion criteria of the study, the participants will be randomly assigned to two groups: "Acceptance and Commitment Therapy" (intervention group) and "Waiting List" (control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with migraine, aged 20 to 50 years, headache history for at least the past 6 months.
Exclusion criteria: Participation in other psychotherapy sessions at least one month prior to the study, lack of consent to participate in the study.
Intervention groups
Intervention group: All individuals who will receive the acceptance and commitment therapy intervention.
Control group: All individuals who will not receive any intervention.
Islamic Azad University of Ahvaz (Science and Research Unit)
Country
Iran (Islamic Republic of)
Phone
+98 61 3444 2015
Email address
azin.hb1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-16, 1405/04/25
Expected recruitment end date
2026-08-01, 1405/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of acceptance and commitment therapy on emotional resilience, cognitive avoidance, and rumination in women with migraine.
Public title
The effect of acceptance and commitment therapy on the management of psychological symptoms in women with migraine.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with migraine aged 20 to 50 years
A history of headaches during at least the past 6 months
Exclusion criteria:
Participation in other psychotherapy sessions at least one month before the study
Unwillingness to participate in research
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of the present study will include all female patients with migraine who refer to neurologists at Shafa Hospital in Ahvaz during the specified time period of the study. Purposive sampling method will be used to select the sample. In this way, by referring to the neurology department of Shafa Hospital and obtaining permission from the relevant doctors, a list of patients with migraine will be received. After selecting the samples to a volume of 40 people, based on the inclusion and exclusion criteria of the study, the participants will be randomly assigned to two groups: "Acceptance and Commitment Therapy" (intervention group) and "Waiting List" (control group). Randomization will be performed using random blocks with variable sizes (4 and 6 people) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and numbered envelopes so that the researcher and participants are not aware of the allocation sequence (allocation concealment). Opening the envelope and informing the group allocation will only be done when each participant enters the study. To ensure the equality of the baseline variables (such as anxiety level, age, and headache frequency and severity), their distribution in the two groups will be examined during the statistical analysis stage.
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
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
Measurement will be using the Connor and Davidson Resilience Scale.
2
Description
Cognitive avoidance
Timepoint
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
Measurement will be done using the Cognitive Avoidance Questionnaire.
3
Description
Rumination
Timepoint
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
Measurement will be using the rumination response scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acceptance and commitment therapy. Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Sequence of sessions: twice a week; Therapeutic tools used: acceptance exercises, cognitive dissociation exercises, presence-in-the-moment exercises, identification of personal values, and committed action exercises. The content of the different sessions is based on the following: Session 1: Pre-test, introduction to the concept of migraine and its relationship with excessive control, Session 2: Focus on the concept of "acceptance" instead of "coping"; teaching how to accept sensory and emotional experiences without trying to eliminate or change them in an avoidant manner. Session 3: Teaching "cognitive dissociation" techniques to reduce the power of rumination and learn how to observe thoughts instead of drowning in them. Session 4: "Presence-in-the-moment" and mindfulness exercises to reduce cognitive avoidance and focus on current experiences instead of worrying about the future or the past. Session 5: Identifying "life values"; helping participants understand what is really important to them in life. Session 6: “Committed Action” exercises; designing small, specific action plans to move toward values, even in the presence of pain or unpleasant thoughts. Session 7: Integrating concepts (self-improvement); teaching how to observe thoughts and feelings from a neutral position and maintain emotional resilience in critical moments. Session 8: Final summary, reviewing coping protocols at home, providing suggestions for maintaining psychological flexibility, administering a post-test, and scheduling a follow-up test.weekly 90-minute group sessions .
Category
Treatment - Other
2
Description
Control group: The control group will not receive any intervention during the research, but to prevent factors that threaten the internal validity of the research, such as compensatory competition by the control group or demoralization, they will receive a compassion therapy intervention after data collection.