Protocol summary

Study aim
Studying the effectiveness of self-compassion therapy on perceived stress, self-differentiation, and functional flexibility in women with multiple sclerosis.
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 40 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
The statistical population of this study includes all women with multiple sclerosis (MS) who have been given a definitive diagnosis of MS by a specialist physician and psychotherapist in a clinical interview and who will refer to the Ahvaz MS Association during the study period. In the sample selection stage, convenience sampling method will be used. After selecting the samples to a volume of 40 people based on the study's entry and exit criteria, the participants will be randomly assigned to two groups: "self-compassion therapy training" (intervention group) and "waiting list" (control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20 to 40 years; definite diagnosis of MS by a clinical specialist. Exclusion criteria: Unwillingness to participate in the study, participation in other psychotherapy sessions concurrently with the study.
Intervention groups
Intervention group: All people who will receive self-compassion therapy. Control group: All people who will not receive any intervention.
Main outcome variables
Perceived stress, self-differentiation, functional flexibility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260605069653N1
Registration date: 2026-06-08, 1405/03/18
Registration timing: prospective

Last update: 2026-06-08, 1405/03/18
Update count: 0
Registration date
2026-06-08, 1405/03/18
Registrant information
Name
Maryam Savari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3333
Email address
asasdhddhjn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-01, 1405/04/10
Expected recruitment end date
2026-07-22, 1405/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of self-compassion therapy on perceived stress, self-differentiation, and functional flexibility in women with Multiple Sclerosis
Public title
Effectiveness of Self-Compassion Training on Mental Health in Women with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women between the ages of 20 and 40 years Definitive diagnosis of MS by a clinical specialist
Exclusion criteria:
Unwillingness to participate in research Participating in other psychotherapy sessions at the same time as the research
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of this study includes all women with multiple sclerosis who have been given a definitive diagnosis of multiple sclerosis by a specialist physician and psychotherapist in a clinical interview and who will refer to the MS Association during the study period. In the sample selection stage, convenience sampling method will be used. After selecting a sample of 40 people based on the study's entry and exit criteria, participants will be randomly assigned to two groups: "self-compassion therapy training" (intervention group) and "waiting list" (control group). Randomization will be performed using the random block method with variable sizes (4 and 6 people) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and numbered envelopes so that the researcher and participants are not aware of the allocation sequence (allocation concealment). Opening the envelope and informing the group allocation will only be done when each participant enters the study. To ensure the equality of the baseline variables (such as anxiety level, age), their distribution in the two groups will be examined during the statistical analysis stage.
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
Ethics Committee of Islamic Azad University of Ahvaz Branch
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2026-05-26, 1405/03/05
Ethics committee reference number
IR.IAU.AHVAZ.REC.1405.137

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
Perceived Stress
Timepoint
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
The method of measurement will be the Cohen et al. (1983) Perceived Stress Questionnaire.

2

Description
Self-Differentiation
Timepoint
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
The measurement method will be the Skowron and Friedlander (1998) differentiation questionnaire.

3

Description
Functional Flexibility
Timepoint
1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention
Method of measurement
The measurement method will be using the Connor and Davidson (2003) Functional Flexibility Questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Self-compassion therapy; Duration: 90 minutes; Number of sessions: 8 sessions; Sequence of sessions: twice a week; Tools: Body-focused mindfulness, compassionate imagery, thought-distancing techniques (for resilience), and emotional boundary exercises (for self-differentiation). Session summary: Session 1: Pre-test; Introduction to the concepts of compassion and its connection with acceptance of MS disease conditions. Session 2: Recognition of the "inner critic" and its effect on perceived stress; Separation of one's feelings from the psychological burden caused by the disease. Session 3: Mindfulness training for managing physical pain; Practice soothing breathing to reduce stress responses of the nervous system. Session 4: Strengthening self-differentiation; Learning to have an "observing self" against the psychological pressures of the environment and others. Session 5: Promoting functional flexibility; Using the compassionate letter writing technique to change the response from "avoidance" to "active acceptance". Session 6: Examining barriers and fears to self-compassion; confronting emotions such as grief or anger regarding physical changes. Session 7: Practicing compassionate imagery to rebuild a compassionate view of the "body"; establishing coping strategies for dealing with stressors of illness. Session 8: Integration; focusing on maintaining autonomy and healthy boundaries (differentiation); implementing a post-test and follow-up plan.
Category
Treatment - Other

2

Description
Control group: 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 from the control group or demoralization, they will receive a self-compassion therapy intervention after data collection.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz MS Association
Full name of responsible person
Maryam Savari
Street address
Faculty of Rehabilitation, Golestan Hospital, Golestan Alley
City
Ahvaz
Province
Khouzestan
Postal code
6133115713
Phone
+98 61 3311 5713
Email
asasdhddhjn@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aslan Egdarnezhad
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
a_eigder@ymail.com
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
Maryam Savari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 28, Jouibar 2 Street, behind the gas station, Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6139715614
Phone
+98 61 3333 3333
Email
asasdhddhjn@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Savari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 28, Jouibar 2 Street, behind the gas station, Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6139715614
Phone
+98 61 3333 3333
Email
asasdhddhjn@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Savari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 28, Jouibar 2 Street, behind the gas station, Pardis
City
Ahvaz
Province
Khouzestan
Postal code
6139715614
Phone
+98 61 3333 3333
Email
asasdhddhjn@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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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