Protocol summary

Study aim
The aim of this study is to evaluate the effectiveness of Mentalization-Based Therapy on metacognitive beliefs, rejection sensitivity, shame, and psychosocial flexibility in individuals with avoidant personality Syndrome.
Design
The research method in this study follows an experimental design, including a pre-test, post-test, and a two-month follow-up with a control group. Group assignment is done randomly.
Settings and conduct
The intervention was conducted at Didar Clinic in Isfahan. Sessions were held twice a week. Participants were randomly assigned to groups.
Participants/Inclusion and exclusion criteria
Entry Criteria: Having symptoms of avoidant personality disorder, being aged between 20-40 years, and possessing at least a high school diploma. Exclusion Criteria: Presence of psychological disorders such as bipolar disorder with manic or hypomanic episodes or a history of schizophrenia diagnosis; substance use disorders (abuse or dependence) in the past 6 months; active suicidal thoughts or suicide attempts in the past 6 months; intellectual disability or borderline intelligence (IQ < 70 or clinical diagnosis); inability to read, write, or complete questionnaires; receiving individual psychotherapy during the screening period; unwillingness or inability to provide informed and voluntary consent.
Intervention groups
Intervention Group Participants undergo mentalization-based treatment. The treatment consists of 8 to 10 weekly group sessions, focusing on improving the ability to understand one’s own and others’ mental states, emotion regulation, and reducing avoidance patterns and shame-based behaviors. Control Group Participants in this group do not receive any active therapeutic intervention during the study period. They are only assessed during the pre-test and post-test phases.
Main outcome variables
Severity of Avoidant Personality Disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251020067691N1
Registration date: 2025-11-19, 1404/08/28
Registration timing: prospective

Last update: 2025-11-19, 1404/08/28
Update count: 0
Registration date
2025-11-19, 1404/08/28
Registrant information
Name
Farid Manouchehry
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 294 4969
Email address
farid.manouchehry97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of mentalization therapy on metacognitive beliefs, rejection sensitivity, emotion of shame, and psycho-social flexibility between the individuals with avoidant personality syndrome.
Public title
The effectiveness of mentalization therapy on improving negative metacognitive beliefs, rejection sensitivity, and feelings of shame in individuals with avoidant personality traits
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
including avoidant personality syndrome Age between 20-40 y.o. Having at least a high school diploma
Exclusion criteria:
Presence of psychological disorders such as bipolar disorder with manic or hypomanic episodes, or a history of schizophrenia diagnosis. Presence of substance use disorder (abuse or dependence) within the past six months. Presence of active suicidal ideation or a suicide attempt within the past six months. Presence of intellectual disability or borderline intellectual functioning (IQ < 70 or clinical diagnosis). Inability to read, write, or complete self-report questionnaires. Receiving individual psychotherapy at the time of screening. Lack of willingness or inability to provide voluntary and informed consent.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to either the intervention or control group using simple randomization. After confirming eligibility and obtaining informed consent, each participant will be assigned a random number between 0 and 1 generated by a computer program (Excel) . Participants with a number ≤ 0.5 will be placed in the intervention group, and those with a number > 0.5 in the control group. To ensure unbiased allocation, the randomization sequence will be generated by an independent researcher not involved in recruitment. The sequence will be stored in a coded list to maintain allocation concealment. The principal investigator responsible for participant enrollment will remain unaware of group assignments until allocation. Whenever possible, the post-test outcome assessor will be blinded to group allocation to minimize assessment bias.
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 Najafabad
Street address
Islamic Azad University of Najafabad., Daneshgah Blvd., Najafabad., Isfahan., Iran.
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2025-07-31, 1404/05/09
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1404.177

Health conditions studied

1

Description of health condition studied
Avoidant Personality Syndrome
ICD-10 code
F60.6
ICD-10 code description
Avoidant personality disorder

Primary outcomes

1

Description
Severity of Avoidant Personality Disorder
Timepoint
Before the intervention, immediately after the intervention, and two months after the intervention
Method of measurement
Avoidant Personality Disorder Severity Index

Secondary outcomes

1

Description
Metacognitive Beliefs
Timepoint
Before, immediately after, and two months after the intervention
Method of measurement
Meta-Cognition Questionnaire(MCQ-30)

2

Description
Rejection Sensitivity
Timepoint
Before, immediately after, and two months after the intervention
Method of measurement
Interpersonal sensitivity Questionnaire( IPSM-32)

3

Description
Shame Emotion
Timepoint
Before, immediately after, and two months after the intervention
Method of measurement
Guilt and Shame Proneness scale(GASP)

4

Description
Psycho-Social Flexibility
Timepoint
Before, immediately after, and two months after the intervention
Method of measurement
Multidimensional Psychological Flexibility Inventory-24

Intervention groups

1

Description
Intervention group: Mental Reconstruction-Based Therapy Group: The goal of mental reconstruction-based therapy is to establish balance in addressing the issues of individuals with avoidant personality disorder symptoms by enhancing their capacity for awareness of mental states influenced by dysfunctional metacognitive beliefs, sensitivity to rejection, feelings of shame, and their level of psychological-social flexibility. The interventions lasted for 8 weeks. Sessions were held twice a week, each lasting two hours. The sessions included the following topics: the concept of mental reconstruction, understanding problems related to mental reconstruction, why we have emotions and their basic types, how to record and regulate emotions, the relationship between mental reconstruction and emotions, the importance of mental reconstruction, the concept of personality disorders and avoidant personality disorder, and the application of mental reconstruction-based therapy.
Category
Treatment - Other

2

Description
Control group: No psychotherapy intervention: Subjects in this group did not receive individual or group psychological interventions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Didar Psychological Clinic
Full name of responsible person
Dr. Gholamreza Talebi
Street address
2nd floor,. No.44,. Amin Alley,. In front of Seyyed al-shohada Hospital,. Shiri Bridge
City
Isfahan
Province
Isfehan
Postal code
8179983675
Phone
+98 31 3237 1672
Email
farid.manouchehry@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Iman Sadeghkhani
Street address
Islamic Azad University of Najafabad., Daneshgah Blvd., 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
Farid Manouchehry
Position
M.A. Student in Clinical Psychology, Department of Psychology, Najafabad Branch, Islamic Azad Univer
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Najafabad., Daneshgah Blvd., Najafabad., Isfahan., Iran.
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 913 294 4969
Email
farid.manouchehry97@gmail.com

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,, Department of Medicine, Na.C., Islamic Azad University, N
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Najafabad., Daneshgah Blvd., Najafabad., Iran.
City
Najafabad
Province
Isfehan
Postal code
8514143131
Phone
+98 913 317 0681
Email
rezatalebi@iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farid Manouchehry
Position
. M.A. Student in Clinical Psychology, Department of Psychology, Najafabad Branch, Islamic Azad Uni
Latest degree
Bachelor
Other areas of specialty/work
Psychiatrics
Street address
Islamic Azad University of Najafabad., Daneshgah Blvd., Najafabad., Isfahan., Iran.
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 913 294 4969
Email
farid.manouchehry97@gmail.com

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 primary outcome results of the study can be shared after anonymization and ensuring individuals' privacy.
When the data will become available and for how long
Data can be made available 4 months after publication of the results and after the removal of personal identifying information.
To whom data/document is available
Data and study 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 are available for scientific and research purposes. Users must commit to keeping non-identifiable data confidential.
From where data/document is obtainable
For data inquiries, please contact via email at farid.manouchehry97@gmail.com.
What processes are involved for a request to access data/document
After receiving the request and reviewing it by the researcher, a response will be provided as soon as possible.
Comments
Loading...