1. Home
  2. Approved trials
  3. » فارسی

Studying the effectiveness of cognitive behavioral group therapy on early maladaptive schemas, functional flexibility, distress tolerance, and self-differentiation of women undergoing drug treatment

Protocol summary

Study aim
Determining the effectiveness of cognitive behavioral group therapy on early maladaptive schemas, functional flexibility, distress tolerance, and self-differentiation in women undergoing drug treatment with multiple sclerosis in Ahvaz.
Design
A controlled clinical trial with parallel groups, double-blind, randomized, on 40 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Using purposive sampling, after referring to the Ahvaz MS Association and conducting a clinical interview by a clinical specialist, initially, 40 of them were selected by simple random sampling (drawing). Then, they were divided into 2 groups of 20 people and finally, they were assigned to the experimental group and the control group by simple random sampling. Blinding was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 20 to 40 years, women with MS, no participation in other psychotherapy sessions at least one month before the study. Inclusion criteria: absence of more than two sessions, simultaneous participation in other psychological treatments, unwillingness to continue treatment.
Intervention groups
The Intervention Group Includes Women Undergoing Pharmacological Treatment With Multiple Sclerosis in Ahvaz City, Who Receive the Intervention: Cognitive Behavioral Group Therapy on Early Maladaptive Schemas, Action Flexibility, Distress Tolerance, and Self-Differentiation. The Comparison Group Includes Women Undergoing Pharmacological Treatment With Multiple Sclerosis in Ahvaz City, Who Receive the Intervention: (Receiving Standard Pharmacological Treatment and Not Receiving Cognitive Behavioral Group Therapy)
Main outcome variables
Early maladaptive schemas, functional flexibility, distress tolerance, and self-differentiation in women undergoing drug treatment for multiple sclerosis.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250529065966N1
Registration date: 2025-07-26, 1404/05/04
Registration timing: prospective

Last update: 2025-07-26, 1404/05/04
Update count: 0
Registration date
2025-07-26, 1404/05/04
Registrant information
Name
fatmeh deynavizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4237 7753
Email address
fatmehdeynavizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-31, 1404/05/09
Expected recruitment end date
2025-12-30, 1404/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of cognitive behavioral group therapy on early maladaptive schemas, functional flexibility, distress tolerance, and self-differentiation of women undergoing drug treatment
Public title
The effect of cognitive behavioral group therapy on early maladaptive schemas, functional flexibility, distress tolerance, and self-differentiation in women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20 to 40 years for women with MS Definitive diagnosis of MS by a specialist doctor Signing a written consent form to participate in the research and adhere to treatment Minimum education: Diploma
Exclusion criteria:
Attending other psychotherapy sessions at least one month before the study Substance use and lack of psychotic symptoms and a history of brain diseases such as brain tumors
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
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 in the control group or demoralization, they will be assured that they will receive problem-solving skills training in the next round (after data collection).
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Ahvaz Branch
Street address
Golestan Highway - Farhang City - Islamic Azad University, Ahvaz Unit
City
AHWAZ
Province
Khouzestan
Postal code
3733361349
Approval date
2024-12-24, 1403/10/04
Ethics committee reference number
IR.IAU.AHVAZ.REC.1403.421

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Early maladaptive schemas: Deep, dysfunctional thought patterns and beliefs that are formed early in life and can cause psychological problems.
Timepoint
At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention
Method of measurement
Young's Early Maladaptive Schemas Questionnaire

Secondary outcomes

1

Description
Functional flexibility: A person's ability to adapt their behaviors and attitudes to different situations and changing circumstances.
Timepoint
At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention
Method of measurement
Functional Flexibility Questionnaire: Connor and Davidson (2003)

2

Description
At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention
Timepoint
At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention
Method of measurement
Distress Tolerance Questionnaire: Simmons and Gahr (2005)

3

Description
Self-differentiation: The ability of an individual to maintain their identity and independence in close relationships, without losing connection and intimacy.
Timepoint
At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention
Method of measurement
Skowron and Friedlander Differentiation Questionnaire:

Intervention groups

1

Description
Type of intervention: In addition to receiving standard medication for multiple sclerosis (as prescribed by a specialist), this group participates in 12 sessions of cognitive-behavioral group therapy (CBT). Sessions are held weekly, each session lasting 90 minutes, at the counseling center. The intervention includes identifying and modifying early maladaptive schemas, training in functional flexibility, distress tolerance, and self-differentiation skills. Sessions are conducted by an experienced clinical psychologist trained in cognitive-behavioral therapy in groups (6 to 10 people per group).
Category
N/A

2

Description
Control group: The comparison group includes women undergoing drug treatment for multiple sclerosis in Ahvaz who receive the intervention (receiving standard drug treatment and not receiving cognitive behavioral group therapy). Also, there will be no intervention for the control group. However, to prevent threats to the internal validity of the test, the intervention will be implemented for them after the end of the study. After completing the training period, both the experimental and control groups (40 people) will be re-assessed by questionnaires that measure the dependent variables (early maladaptive schemas, functional flexibility, distress tolerance, self-differentiation) as a post-test, and finally, after one month of the post-test, both groups will be re-assessed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Ahvaz Unit
Full name of responsible person
Sasan Bavi
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pejman Taghipour Birgani
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 3334 8420
Email
info@iauahvaz.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
Sasan Bavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3332 9200
Fax
Email
sasanbavi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sasan Bavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3332 9200
Fax
Email
sasanbavi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatmeh Deynavizadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ground floor unit, Block 7, Gol Narges site, Mehr Shahr
City
Dezful
Province
Khouzestan
Postal code
3733361349
Phone
+98 61 4237 7753
Fax
Email
fatmehdeynavizadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...