Protocol summary

Study aim
The Effectiveness of Compassion-Based Therapy (CFT) on Internalized Shame and Social Anxiety in Female Students with Body Dysmorphic Disorder in Azad University
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 30 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
The statistical population of the present study includes all female students at various levels of education at Islamic Azad University, Ahvaz Branch, in the second semester of the academic year 1404-1405 who have body dysmorphic syndrome. In the sample selection stage, the available sampling method is used. After selecting the samples to a volume of 30 people based on the research entry and exit criteria, the participants will be randomly assigned to two groups: "Compassion-based couple therapy" (intervention group) and "waiting list" (control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Score above the cut-off point on the Body Dysmorphic Disorder Questionnaire, girls aged 18 to 30, being a student at Ahvaz Azad University. Exclusion criteria: Unwillingness to participate in the study, receiving psychological services or medication
Intervention groups
Intervention group 1: All individuals who will receive compassion-based therapy. Control group: All individuals who will not receive any intervention.
Main outcome variables
Internalized Shame, Social Anxiety, Body Dysmorphic Disorder Syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260510069338N1
Registration date: 2026-05-14, 1405/02/24
Registration timing: prospective

Last update: 2026-05-14, 1405/02/24
Update count: 0
Registration date
2026-05-14, 1405/02/24
Registrant information
Name
Atefeh Shomalzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3333
Email address
atefehshomalzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-26, 1405/03/05
Expected recruitment end date
2026-06-10, 1405/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Compassion-Based Therapy (CFT) on Internalized Shame and Social Anxiety in Female Students with Body Dysmorphic Disorder in Azad University
Public title
Investigating the effectiveness of compassion-based therapy on internalized shame and social anxiety in female students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Score above the cut-off point on the Body Dysmorphic Disorder Questionnaire Girls aged 18 to 30 Being a student at Ahvaz Azad University.
Exclusion criteria:
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population of the present study consists of all female students at different educational levels of Islamic Azad University, in the second semester of the 2025–2026 academic year who exhibit body dysmorphic symptoms. In this type of effectiveness study, a two-stage approach is typically used: in the sample selection stage, convenience sampling is employed. After selecting the sample to a size of 30 participants based on the study’s inclusion and exclusion criteria, the participants will be randomly assigned to two groups: Compassion-Based Couple Therapy (intervention group) and waiting list (control group). Randomization will be carried out using variable block randomization with block sizes of 4 and 6 by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Microsoft Excel and then placed in opaque, sealed, and numbered envelopes so that neither the researcher nor the participants will be aware of the allocation sequence (allocation concealment). The envelopes will be opened, and the assigned group will be revealed only at the time each participant enters the study. To ensure the equality of baseline variables, such as anxiety level and age, their distribution across the two groups will be examined during the statistical analysis phase.
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
2026-04-11, 1405/01/22
Ethics committee reference number
IR.IAU.AHVAZ.REC.1405.024

Health conditions studied

1

Description of health condition studied
Body Dysmorphic Disorder Syndrome
ICD-10 code
F45.22
ICD-10 code description
Body Dysmorphic Disorder

Primary outcomes

1

Description
Internalized Shame
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 was David R. Cook's (1987) Internalized Shame Scale.

2

Description
Social Anxiety
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 SPIN questionnaire by Kathleen Connor et al. (2000).

3

Description
Body dysmorphic disorder syndrome
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 revised Yale-Brown Obsessive-Compulsive Scale for Body Dysmorphic Disorder by Katherine Phillips et al. (1997).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Compassion-Focused Therapy. Session Duration: 60 minutes.Total Sessions: 8 sessions. Session Frequency: Twice per week.Therapeutic Tools Used.This intervention focuses on activating internal compassion resources and reducing self-criticism, incorporating guided therapeutic dialogue, mindfulness exercises, self-compassion imagery, soothing breathing techniques, and compassionate writing exercises.Summary of Session Content: Session 1: Introduction to the therapy, explanation of compassion and shame concepts, pre-test administration. Session 2: Identification of thoughts and behaviors associated with internalized shame and social anxiety. Session 3: Training in compassionate imagery and soothing breathing techniques. Session 4: Mindfulness practice and non-judgmental acceptance of emotions. Session 5: Compassionate letter writing and strengthening self-compassion. Session 6: Examination of factors contributing to self-criticism and shame. Session 7: Training in coping strategies and relaxation techniques. Session 8: Conclusion, review of learned material, post-test administration, and scheduling of follow-up assessment.
Category
Treatment - Other

2

Description
Control group: The control group will not receive any intervention during the research, but will receive the intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Ahvaz Branch
Full name of responsible person
Atefeh Shomalzadeh
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
info@iauahvaz.ac.ir

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
Atefeh Shomalzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 7, 7th Street, Sadeghieh Alley
City
Ahvaz
Province
Khouzestan
Postal code
6177944466
Phone
+98 61 3228 0798
Email
atefehshomalzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atefeh Shomalzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 7, 7th Street, Sadeghieh Alley
City
Ahvaz
Province
Khouzestan
Postal code
6177944466
Phone
+98 61 3228 0798
Email
atefehshomalzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atefeh Shomalzadeh
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 7, 7th Street, Sadeghieh Alley
City
Ahvaz
Province
Khouzestan
Postal code
6177944466
Phone
+98 61 3228 0798
Email
atefehshomalzadeh@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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