The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) on Alexithymia, Self-Critical Rumination, and Psychological Flexibility in Individuals with Somatic Symptom Disorder
Determining the effectiveness of mindfulness-based cognitive therapy (MBCT) on alexithymia, self-critical rumination, and psychological flexibility in people with somatic symptom disorder
Design
This clinical trial study is a controlled, parallel-group, unblinded, and randomized (sealed envelope) study. It is conducted on 38 individuals with somatic symptom disorder referred to psychotherapy centers located in Isfahan. The sealed envelope method was used for randomization.
Settings and conduct
38 eligible individuals were randomly assigned to two experimental and control groups (19 each). Both groups completed the pre-test questionnaires of emotional alexithymia, self-critical rumination, and psychological flexibility. The experimental group participated in 8 sessions of 90 minutes of mindfulness-based cognitive therapy at the analytical psychotherapy center. The control group did not receive any treatment. Finally, both groups completed the post-test.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having somatic symptom disorder; Age range between 20 and 50 years; Sufficient physical ability to attend the sessions; Informed consent and willingness to participate in the research process; Minimum literacy level (reading and writing skills)
Exclusion Criteria: Receiving any psychological treatment in the control group
; Presence of acute psychological disorders such as depression or anxiety, according to psychiatric history; History of physical illnesses requiring medication or special dietary regimen
Intervention groups
19 eligible individuals who complete research questionnaires as a pre-test but do not receive any treatment. Intervention group: 19 eligible individuals who participated in mindfulness-based cognitive therapy sessions after the pre-test.
The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) on Alexithymia, Self-Critical Rumination, and Psychological Flexibility in Individuals with Somatic Symptom Disorder
Public title
The effectiveness of mindfulness-based cognitive therapy in Individuals with Somatic Symptom Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having somatic symptom disorder
Age range between 20 and 50 years
Sufficient physical ability to attend the sessions
Informed consent and willingness to participate in the research process
Minimum literacy level (reading and writing skills)
Exclusion criteria:
Receiving any psychological treatment in the control group
Presence of acute psychological disorders such as depression or anxiety, according to psychiatric history
History of physical illnesses requiring medication or special dietary regimen
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Experimental and control groups: After selecting the sample, the next step involves dividing people into experimental and control groups using a random method.
How to perform randomization: First step: After selecting the voluntary sample, all selected people are placed on a list (numbers from one to 38 are assigned to people). Second step: From these people, using a random method with sealed and opaque (numbered) envelopes, individuals are divided into experimental and control groups. Each person randomly selects an envelope and is divided into the corresponding group.
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
Research Ethics Committees of Islamic Azad University- Najafaba Branch
Street address
Islamic Azad University, Najafabad Branch, Daneshgah Boulevard, Najafabad, Isfahan, Iran
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2025-07-24, 1404/05/02
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1404.149
Health conditions studied
1
Description of health condition studied
Somatic Symptom Disorder
ICD-10 code
F48.9
ICD-10 code description
Nonpsychotic mental disorder, unspecified
Primary outcomes
1
Description
Alexithymia
Timepoint
Before intervention and after intervention
Method of measurement
Toronto Emotional Alexithymia Questionnaire
2
Description
Self-Critical Rumination
Timepoint
Before intervention and after intervention
Method of measurement
The Self-Critical Rumination Questionnaire, Smart et al.
3
Description
Psychological Flexibility
Timepoint
Before intervention and after intervention
Method of measurement
Dennis and Vander-Waal Psychological Flexibility Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 19 participants who meet the inclusion criteria will be randomly assigned to the control group. They will complete the Alexithymia, Self-Critical Rumination, and Psychological Flexibility questionnaires, but no treatment will be given to this group.
Category
Behavior
2
Description
Intervention group: 19 people with somatic symptom disorder who refer to psychotherapy centers in Isfahan and meet the inclusion criteria will be randomly assigned to the study as the intervention group. They will complete the alexithymia, self-critical rumination, and psychological flexibility questionnaires as a pre-test. They will then undergo 8 mindfulness-based cognitive therapy sessions based on the Crane 2017 protocol, each session lasting 90 minutes, at the Isfahan Analytical Psychotherapy Center. After completing the sessions, they will complete the alexithymia, self-critical rumination, and psychological flexibility questionnaires as a post-test.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tahlili Psychotherapy Center
Full name of responsible person
Sajedeh Nourbehesht
Street address
Unit 19, Block B, Azadi Complex, Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۶۳۹۱۳۱۴۹
Phone
+98 31 3662 0611
Email
Sajedeh_nourbehesht@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Iman Sadeghkhani
Street address
Islamic Azad University, Najafabad Branch, Daneshgah Boulevard, Najafabad, Isfahan, Iran
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2929
Email
info @ iaun.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
Public
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
Zahra Soltani Tehrani
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 14, Shahid Ebrahim Vaezz Alley, Motahari Street, District 4, Tiran County, Isfahan, Iran
City
Tiran
Province
Isfehan
Postal code
8531618591
Phone
+98 991 318 0986
Email
zahrasoltani.tehrani2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elhamsadat Binandeh
Position
Assistant Professor, Islamic Azad University of Isfahan, Khorasgan Branch
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Najafabad Branch, Daneshgah Boulevard, Najafabad, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 913 269 9043
Email
el.binande@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Soltani Tehrani
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 14, Shahid Ebrahim Vaezz Alley, Motahari Street, District 4, Tiran County, Isfahan, Iran
City
Tiran
Province
Isfehan
Postal code
8531618591
Phone
+98 991 318 0986
Email
zahrasoltani.tehrani2000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.
When the data will become available and for how long
Data can be made available 4 months after the results are published and after personally identifiable information is removed.
To whom data/document is available
The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.
Under which criteria data/document could be used
Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.
From where data/document is obtainable
If you need data, please contact zahrasoltani.tehrani2000@gmail.com
What processes are involved for a request to access data/document
After receiving and reviewing the request from the researcher, the request will be responded to as soon as possible.