To determine the effectiveness of schema therapy on quality of life and psychological well-being in women with multiple sclerosis (MS).
Design
This study will be conducted as a quasi-experimental trial with a pretest, posttest, and follow-up design and a control group; allocation to groups will be performed by simple random assignment with a 1:1 ratio.
Settings and conduct
This study will be conducted at Imam Ali Psychiatric and Neurological Specialty Clinic, Zanjan, during the second half of the Iranian year 1405. Participants will be recruited through convenience sampling and randomly allocated to two groups; a pretest will be administered; the experimental group will then receive 15 intervention sessions; a posttest will follow, and a follow-up assessment will be conducted two months later.
Participants/Inclusion and exclusion criteria
Inclusion: women who have a confirmed diagnosis of multiple sclerosis by a specialist physician; are aged 20 to 60 years; will provide informed consent; have at least a high school education; will be receiving pharmacological treatment for MS; will not be receiving concurrent psychotherapy. Exclusion: those who have an acute or chronic psychiatric disorder; will be absent from more than two treatment sessions.
Intervention groups
Experimental group: will receive 15 weekly 90-minute group schema therapy sessions based on Young's protocol. Control group: will receive no intervention; will be offered the intervention after study completion.
Main outcome variables
Quality of life (measured with the Multiple Sclerosis Quality of Life Questionnaire, MSQOL-54) and psychological well-being (measured with the 18-item short form of the Ryff Psychological Well-Being Scale) will be assessed at pretest, posttest, and follow-up.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260927071205N1
Registration date:2026-10-14, 1405/07/22
Registration timing:registered_while_recruiting
Last update:2026-10-14, 1405/07/22
Update count:0
Registration date
2026-10-14, 1405/07/22
Registrant information
Name
Mojtaba Rahnamazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4427 1329
Email address
mojtaba.rahnama@iau.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-14, 1405/07/22
Expected recruitment end date
2026-12-13, 1405/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Schema Therapy on Quality of Life and Psychological Well-being in Women with Multiple Sclerosis
Public title
Effect of Schema Therapy on Quality of Life and Psychological Well-being in Women with MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of multiple sclerosis by a specialist physician
Age between 20 and 60 years
Informed consent to participate
At least a high school education
Receiving pharmacological treatment for MS
Not receiving concurrent psychotherapy
Exclusion criteria:
Acute or chronic psychiatric disorder
Absence from more than two treatment sessions
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the sample size, 30 participants will be randomly allocated, using simple random assignment by lottery, into two equal groups of experimental and control (15 participants each).
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 Committee of Islamic Azad University, Ayatollah Amoli Branch
Street address
No. 40, Fajr 11, Noor Street
City
Amol
Province
Mazandaran
Postal code
4616915686
Approval date
2025-09-02, 1404/06/11
Ethics committee reference number
IR.IAU.AMOL.REC.1404.136
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
Quality of life (measured with the Multiple Sclerosis Quality of Life Questionnaire, MSQOL-54) and psychological well-being (measured with the 18-item short form of the Ryff Psychological Well-Being Scale) will be assessed at pretest, posttest, and follow-up
Timepoint
Pretest (before the intervention), posttest (immediately after the 15th session), and follow-up (two months after the end of the intervention)
Method of measurement
uality of life using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire, and psychological well-being using the 18-item short form of Ryff's Psychological Well-Being Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in this group receive "Group Schema Therapy" based on Young's standard protocol for MS patients. The program consists of 15 weekly 90-minute sessions (total of 15 weeks) as follows:Phase 1: Assessment and Psychoeducation (Sessions 1–4)Objectives: Identifying Early Maladaptive Schemas (e.g., Defectiveness, Dependence, Self-Sacrifice) and developing an understanding of the relationship between schemas and disease experiences.Activities:Session 1: Introduction to therapy and group principles, completion of the YSQ-S3 questionnaire, reviewing the patient's life history and its connection to schemas.Session 2: Analysis of schemas activated by the illness (e.g., "I am worthless" due to physical disability), psychoeducation on the concept of "Schema Modes" (Vulnerable Child, Punitive Parent).Sessions 3 & 4: Utilization of the "Historical Imagery" technique to explore the roots of schemas (e.g., childhood rejection experiences).Phase 2: Schema Change and Cognitive Restructuring (Sessions 5–10)Objectives: Weakening maladaptive schemas and strengthening the "Healthy Adult" mode.Activities:Session 5: Schema dialogue: Dialoguing with the "Defectiveness" schema as a separate entity.Session 6: "Letter Therapy" exercise: Writing letters to schemas from the perspective of the Healthy Adult.Sessions 7 & 8: Cognitive restructuring using belief challenge worksheets (e.g., replacing "I am a burden to others" with "I am valuable despite my limitations").Sessions 9 & 10: "Limited Emotional Catharsis" technique to reduce anger toward the body.Phase 3: Reinforcing Adaptive Behaviors and Relapse Prevention (Sessions 11–15)Objectives: Replacing maladaptive behavioral patterns with healthy behaviors.Activities:Session 11: Designing a "Behavioral Plan" to reduce excessive self-sacrifice (e.g., saying no to unreasonable requests from others).Session 12: Role-playing to practice constructive social interactions.Sessions 13 & 14: Chair technique practice for schema modes: Dialogue between the "Vulnerable Child" and the "Healthy Adult".Session 15: Reviewing achievements, formulating a long-term self-care plan, and final assessment (Young, 2023).
Category
Behavior
2
Description
Control group: Control group: Participants in this group receive no psychological intervention during the study period and are placed on a waiting list. For ethical considerations, after the completion of the study, post-test, and follow-up assessments, an abbreviated course of Schema Therapy will be offered to the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali (AS) Specialized Psychiatry and Mental Health Clinic
Full name of responsible person
Mojtaba Rahnamazadeh
Street address
No. 40, Fajr 11, Noor Street
City
Amol
Province
Mazandaran
Postal code
4616915686
Phone
+98 911 921 4001
Email
mojtaba.rahnama@iau.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esmaeil Fattahi
Street address
Islamic Azad University, Ayatollah Amoli Branch, University Access Road, 5th kilometer of the old Amol-Babol road, Amol, Mazandaran
City
Amol
Province
Mazandaran
Postal code
۴۳۳۵۸-۴۶۳۵۱
Phone
+98 911 921 4001
Email
info@iauamol.ac.iu.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
Mojtaba Rahnamazadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 40, Fajr 11, Noor Street
City
Amol
Province
Mazandaran
Postal code
4616915686
Phone
+98 11 4427 1329
Email
mojtaba.rahnama@iau.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojtaba Rahnamazadeh
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 40, Fajr 11, Noor Street
City
Amol
Province
Mazandaran
Postal code
4616915686
Phone
+98 11 4427 1329
Email
mojtaba.rahnama@iau.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojtaba Rahnamazadeh
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 40, Fajr 11, Noor Street
City
Amol
Province
Mazandaran
Postal code
4616915686
Phone
+98 11 4427 1329
Email
mojtaba.rahnama@iau.ir
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
To protect participants' confidentiality, and in accordance with the informed consent, which permits the use of data only for the purposes of this study, there is no plan to share individual participant data. Results will be reported at the group level.