The Effectiveness of Acceptance and Commitment Therapy on Health Anxiety, Meta‑Worry, Health‑Promoting Lifestyle, and Cognitive Flexibility in Psychosomatic Patients with Migraine
Determining the effectiveness of acceptance and commitment therapy on health worry, meta-worry, health-promoting lifestyle, and cognitive flexibility in psychosomatic patients with migraine
Design
The clinical trial will use a pretest-posttest design with experimental and control groups, and individuals will be randomly assigned to the experimental and control groups.
Settings and conduct
This research is a field experimental study with a pre-test-post-test design and a control group. The statistical population of the present study is psychosomatic patients with migraine referring to psychiatric clinics in Ahvaz in 1403. After preparing a list of eligible patients, 30 people were selected by simple random selection and were divided into two experimental groups (15 people) and control groups (15 people) by assigning random numbers. The experimental group will receive the acceptance and commitment therapy method from the Shirali and Dasht-e-Bozorgi package (2019) based on the Foreman and Herbert (2009) protocol in 10 60-minute sessions.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Aged 31 to 50 years
Diagnosis of psychosomatic symptoms and migraine in them
Having consent to participate in the research
Exclusion Criteria
Substance addiction
Use of psychiatric medications such as anti-anxiety and antidepressants
Receipt of psychological services within the past three months
History of receiving Acceptance and Commitment Therapy
Intervention groups
Intervention group: Receives the acceptance and commitment therapy method from the Shirali and Dasht-e-Bozorgi package (2019) based on the Forman and Herbert protocol (2009) in 10 60-minute sessions. Control group: Receives no intervention.
Main outcome variables
Health concern; Meta-worry; Health-promoting lifestyle; Cognitive flexibility.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250915067256N1
Registration date:2025-09-18, 1404/06/27
Registration timing:prospective
Last update:2025-09-18, 1404/06/27
Update count:0
Registration date
2025-09-18, 1404/06/27
Registrant information
Name
Hossein Namazi Furoshani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 584 3408
Email address
h.namazi.f@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-07, 1404/07/15
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Acceptance and Commitment Therapy on Health Anxiety, Meta‑Worry, Health‑Promoting Lifestyle, and Cognitive Flexibility in Psychosomatic Patients with Migraine
Public title
Effectiveness of Acceptance and Commitment Therapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 31 to 50 years
Diagnosis of psychosomatic symptoms and migraine in them
Having consent to participate in the research
Exclusion criteria:
Substance addiction
Use of psychiatric medications such as anti-anxiety and antidepressants
Receipt of psychological services within the past three months
History of receiving Acceptance and Commitment Therapy
Age
From 31 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, to achieve complete random allocation and eliminate any researcher interference or bias, the simple randomization method will be employed. First, a complete list of women attending the counseling center who meet the inclusion criteria will be prepared. Then, each participant will be assigned an initial numerical identification code. These codes will be entered into the Random Number Generator software, which will generate a unique random number for each individual. After generating the numbers, participants will be arranged in ascending order based on their random number values. Subsequently, the first fifteen individuals on the list will be assigned to the experimental group, and participants numbered sixteen to thirty will be assigned to the control group. This process is designed in such a way that neither the order of entry nor the researcher’s prior knowledge of the participants plays any role in allocation, and it will be impossible to predict any participant’s group before the completion of the randomization process.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Ahvaz
Street address
No. 44, Amir Building, Unit 9, 1st Behdari St., Behind Al-Hadi Mosque, Ariashahr
City
Ahvaz
Province
Khouzestan
Postal code
6184694880
Approval date
2025-07-23, 1404/05/01
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.256
Health conditions studied
1
Description of health condition studied
Psychosomatic symptoms of migraine
ICD-10 code
F45.0
ICD-10 code description
Somatization disorder
Primary outcomes
1
Description
Health concern
Timepoint
before performing the intervention and two weeks after completion of the intervention
Method of measurement
Wells and Davis Anxious Thought Scale (1994)
2
Description
Metaconcern
Timepoint
before performing the intervention and two weeks after completion of the intervention
Method of measurement
Wells and Davis Anxious Thought Scale (1994)
3
Description
Health-promoting lifestyle
Timepoint
before performing the intervention and two weeks after completion of the intervention
Method of measurement
Walker, Secrist, and Pender Health Promoting Lifestyle Questionnaire (1987)
4
Description
Cognitive flexibility
Timepoint
before performing the intervention and two weeks after completion of the intervention
Method of measurement
Dennis and Vanderwaal Cognitive Flexibility Questionnaire (2010)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acceptance and commitment therapy, as another method derived from the third wave of psychotherapy, has its roots in cognitive behavioral therapy based on contextualism and the theory of mental relations framework and has six basic principles including acceptance, fault-finding, self as context, connection to the present, recognition of values, and committed action (Garcia et al., 2023). The main goal of this therapy is to achieve a more valuable and satisfying life by increasing psychological flexibility. In this study, Forman and Herbert's (2009) model, which was also used in the study by Shirali and Dasht-e-Bozori (2019), will be used for acceptance and commitment therapy.
Category
Behavior
2
Description
Control group: They do not receive any intervention or treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ryan Psychology Clinic
Full name of responsible person
Hossein Namazi Furoshani
Street address
1st floor, Mahtab Complex, between East 4th and 5th Streets, Kianpars.
City
Ahvaz
Province
Khouzestan
Postal code
6155867347
Phone
+98 61 3392 1294
Email
h.namazi.f@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Parvin Ehteshamzadeh
Street address
Islamic Azad University of Ahvaz, Farhang Shahr.
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
p_ehtesham85@iau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Namazi Furoshani
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 44, Amir Building, Unit 9, 1st Behdari St., Behind Al-Hadi Mosque, Ariashahr
City
Ahvaz
Province
Khouzestan
Postal code
6184694880
Phone
+98 930 584 3408
Email
h.namazi.f@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Namazi Furoshani
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 44, Amir Building, Unit 9, 1st Behdari St., Behind Al-Hadi Mosque, Ariashahr
City
Ahvaz
Province
Khouzestan
Postal code
6184694880
Phone
+98 930 584 3408
Email
h.namazi.f@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Namazi Furoshani
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 44, Amir Building, Unit 9, 1st Behdari St., Behind Al-Hadi Mosque, Ariashahr
City
Ahvaz
Province
Khouzestan
Postal code
6184694880
Phone
+98 930 584 3408
Email
h.namazi.f@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is completely confidential and I do not intend to publish it.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available