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The Effectiveness of Short-Term Object Relations Therapy on Self-Efficacy, Identity Reconstruction, Trauma-Related Shame and kinesiophobia in Patients with Multiple Sclerosis (MS)

Protocol summary

Study aim
Investigating the effectiveness of short-term object relations therapy on self-efficacy, identity reconstruction, trauma-related shame, and fear of movement in patients with multiple sclerosis (MS)
Design
The clinical trial has a control group, parallel group, unblinded and randomized (sealed envelope). It is conducted on 36 people with multiple sclerosis referred to Al-Zahra and Kashani Hospitals located in Isfahan. The sealed envelope method was used for randomization.
Settings and conduct
36 eligible individuals were randomly assigned to two experimental and control groups (18 each). Both groups completed the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Identity Reconstruction Scale (IRAS), the Trauma-Related Shame Scale (TRSI), and the Tampa Fear of Movement Scale (TSK) at pretest. The experimental group will participate in 14 sessions of 90-minute, short-term object relations group psychotherapy with the 2009 Ostadter protocol on-site. The control group will receive no therapy. Finally, both groups will complete a posttest.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20 to 50 years old, minimum literacy and ability to complete questionnaires, willingness to participate, and signing an informed consent form ٍExclusion criteria: Severe psychiatric disorders (active psychosis, severe substance dependence, etc.), receiving other concurrent psychotherapy interventions during the study period
Intervention groups
18 eligible individuals who complete the research questionnaires as a pretest but do not receive any treatment. Intervention group: 18 eligible individuals who participated in short-term object relations psychotherapy sessions after the pretest.
Main outcome variables
Self-Efficacy; Identity Reconstruction; Trauma-Related Shame; kinesiophobia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251019067681N1
Registration date: 2025-11-09, 1404/08/18
Registration timing: prospective

Last update: 2025-11-09, 1404/08/18
Update count: 0
Registration date
2025-11-09, 1404/08/18
Registrant information
Name
Ghazal Mesghali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3420 6017
Email address
ghazal.mesghali7412@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-11, 1404/08/20
Expected recruitment end date
2025-12-11, 1404/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Short-Term Object Relations Therapy on Self-Efficacy, Identity Reconstruction, Trauma-Related Shame and kinesiophobia in Patients with Multiple Sclerosis (MS)
Public title
The effectiveness of short-term object relations therapy on patients with multiple sclerosis.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 50 years old Minimum literacy and ability to complete questionnaires Willingness to participate and sign informed consent
Exclusion criteria:
Having severe psychiatric disorders (active psychosis, severe substance dependence, etc.) Receiving other concurrent psychotherapy interventions during the study period
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: 36
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 36 are assigned to people). Second step: From these individuals, a random method is used with sealed and opaque (numbered) envelopes to divide them 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
2025-09-25, 1404/07/03
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1404.223

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
Self-Efficacy
Timepoint
Before intervention and after intervention
Method of measurement
Multiple Sclerosis Self-Efficacy Questionnaire (MSSS) Rigby et al. 2003

2

Description
Identity Reconstruction
Timepoint
Before intervention and after intervention
Method of measurement
Identity Reconstruction Questionnaire for Multiple Sclerosis (IRAS) Stapleman et al.

3

Description
Trauma-Related Shame
Timepoint
Before intervention and after intervention
Method of measurement
Trauma-Related Shame Inventory (TRSI)

4

Description
kinesiophobia
Timepoint
Before intervention and after intervention
Method of measurement
Tampa Scale (TASK-11)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 18 participants who meet the inclusion criteria will be randomly assigned to the control group and will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Stapelman et al. Identity Reconstruction Inventory (IRAS), the Trauma-Related Shame Inventory (TRSI), and the Tampa Fear of Movement Scale (TSK), but will not receive any treatment.
Category
Behavior

2

Description
Intervention group: 18 patients with multiple sclerosis referred to Kashani and Al-Zahra hospitals in Isfahan, who meet the inclusion criteria, will participate in the study as the intervention group randomly. They will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Identity Reconstruction Scale (IRAS), the Trauma-Related Shame Scale (TRSI), and the Tampa Fear of Movement Scale (TSK) as a pre-test, then they will undergo 14 sessions of 90 minutes in the Ostadter 2009 short-term object relations group psychotherapy sessions. And after completing the sessions, they will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Identity Reconstruction Scale (IRAS), the Trauma-Related Shame Scale (TRSI), and the Tampa Fear of Movement Scale (TSK) as a post-test.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Didar Counseling and Psychology Center
Full name of responsible person
Gholamreza Talebi
Street address
2nd Floor, Padna Building, No. 44, Amin Alley Corner, Opposite Seyed Al-Shohada Hospital, Pol-Shiri, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8185855841
Phone
+98 992 991 1400
Email
rezatalebi@iau.ac.ir

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
8514143131
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
Ghazal Mesghali
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Amirkabir Boulevard, Najafabad, Isfahan Province, Iran
City
isfahan
Province
Isfehan
Postal code
8194953479
Phone
+98 903 039 1911
Email
ghazal.mesghali7412@iau.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamreza Talebi
Position
Assistant Professor of Health Psychology, Islamic Azad University, Najafabad
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Najafabad Branch, Daneshgah Boulevard, Najafabad, Isfahan, Iran
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 913 317 0681
Email
rezatalebi@smd.iaun.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghazal Mesghali
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 10. 5th Floor, Maryam Building, Alavinejad st., North Banafsh-e St., Golkhaneh St., Khaneh Esfahan, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8194953479
Phone
+98 903 039 1911
Email
ghazal.mesghali7412@iau.ir

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 ghazal.mesghali7412@iau.ir
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.
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