IRCT | A Comparison of the Effectiveness of Dialectical Behavior Therapy (DBT) With and Without Eye Movement Desensitization and Reprocessing (EMDR) on Mentalization, Emotion Regulation, Psychological Distress, and Suicidal Ideation in Individuals with Borderline Personality Disorder (BPD)

Protocol summary

Study aim: A Comparison of the Effectiveness of Dialectical Behavior Therapy (DBT) With and Without Eye Movement Desensitization and Reprocessing (EMDR) on Mentalization, Emotion Regulation, Psychological Distress, and Suicidal Ideation in Individuals with Borderline Personality Disorder (BPD)
Design: The clinical trial will have two experimental groups and a control group, a blind and randomized strain on 60 patients.
Settings and conduct: After announcing the call, the qualified patients will undergo a clinical interview and pre-test, then the intervention and finally the post-test. This research will be carried out in Iran and the city of Mashhad in the clinic of Ibn Sina Hospital.
Participants/Inclusion and exclusion criteria: Entry criteria include age range of 20-40, at least having a diploma level of education, living in Mashhad, desire and informed consent to participate in the research, the presence of borderline personality symptoms based on the structured clinical interview of personality disorders and Exclusion criteria also include 1- suffering from other psychological and psychiatric disorders such as mood disorders, psychotic disorders and substance use disorder, which will be evaluated through a structured clinical interview for DSM-5. 2- Simultaneously receiving psychological interventions or other drug treatments. 3- Suffering from medical disorders
Intervention groups: Participants of Experimental group 1, dialectical behavior therapy intervention and participants of experimental group 2, DBT-EMDR intervention and the control group will not receive any intervention during the treatment, however, they will have the opportunity to receive one of the therapeutic interventions similar to the intervention groups after the completion of the research.
Main outcome variables: Mentalization, Emotion Regulation, Psychological Distress, and Suicidal Ideation

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20250116064396N1

Registration date: 2025-01-22, 1403/11/03

Registration timing: prospective

Last update: 2025-01-22, 1403/11/03

Update count: 0
Registration date: 2025-01-22, 1403/11/03

Registrant information: Name

Leila Hefazi Torghabeh

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 23 3362 3300

Email address

leila_hefazi@semnan.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-02-19, 1403/12/01
Expected recruitment end date: 2025-03-21, 1404/01/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: A Comparison of the Effectiveness of Dialectical Behavior Therapy (DBT) With and Without Eye Movement Desensitization and Reprocessing (EMDR) on Mentalization, Emotion Regulation, Psychological Distress, and Suicidal Ideation in Individuals with Borderline Personality Disorder (BPD)

Public title: A Comparison of the Effectiveness of Dialectical Behavior Therapy (DBT) With and Without Eye Movement Desensitization and Reprocessing (EMDR) in Individuals with Borderline Personality Disorder (BPD)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age range 20-40 Having at least a diploma level of education Willingness and informed consent to participate in research The presence of borderline personality symptoms based on the structured clinical interview of personality disorders Living in Mashhad

Exclusion criteria:

Suffering from other psychological and psychiatric disorders such as mood disorders, psychotic disorders and substance abuse disorders Simultaneously receiving psychological interventions or other drug treatments suffering from medical disorders
Age: From 20 years old to 40 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

Allocating people to two intervention groups and one control group will be done based on simple random sampling method and using a table of random numbers. First, a list of qualified people is prepared.Then, by assigning numerical ranges for each group (numbers 01-20 for intervention group 1, 20-40 for intervention group 2, 40-60 for control group), the random order of assigning people to groups is determined. This process will continue by randomly selecting one of the numbers in the table and moving from top to bottom to register the numbers.

Blinding (investigator's opinion)

Single blinded

Blinding description

Considering that the researcher wants to implement the intervention, she will know how to implement the intervention and the participants are unaware of the information and the intervention method of the other group.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Semnan University of Medical Sciences

Street address

Iran-Semnan-Basij Boulevard-Administrative headquarters of University of Medical Sciences and Health Services

City

Semnan

Province

Semnan

Postal code

35147-99442
Approval date: 2025-01-15, 1403/10/26
Ethics committee reference number: IR.SEMUMS.REC.1403.258

Health conditions studied

1

Description of health condition studied: Borderline Personality Disorder
ICD-10 code: F60.3
ICD-10 code description: Borderline personality disorder

Primary outcomes

1

Description: Severity of borderline personality disorder
Timepoint: Before and after the intervention
Method of measurement: Structured clinical personality interview

Secondary outcomes

1

Description: Mentalization
Timepoint: Before and after the intervention
Method of measurement: Dimitrijević et al.'s mentalization questionnaire

2

Description: Emotion regulation
Timepoint: Before and after the intervention
Method of measurement: Garnefski & Kraaij 's emotion regulation questionnaire

3

Description: psychological distress
Timepoint: Before and after the intervention
Method of measurement: Lovibond & Lovibond 's psychological distress questionnaire

4

Description: suicidal ideation
Timepoint: Before and after the intervention
Method of measurement: Beck & Steer 's suicidal ideation questionnaire

Intervention groups

1

Description: First intervention group: This group will receive dialectical behavior therapy intervention in the form of 12 one-hour sessions once a week. The goals of therapy sessions include teaching basic skills of mindfulness and practicing being in a wise mind, teaching advanced skills of mindfulness, getting to know the basic skills of coping with chaos, which includes basic acceptance and its methods, returning attention and its methods, self-soothing. Teaching advanced skills to tolerate disturbance such as acceptance by changing the direction of the mind, accepting reality with one's body, getting familiar with the fundamental skills of emotion regulation, which includes recognizing the main emotions, reducing physical vulnerability to disturbing emotions, the difference between emotion, thought, behavior and event, creating a balance between Thoughts and feelings, creating and recording enjoyable activities and continuing to teach advanced emotional regulation skills.Teaching basic effective communication skills and then advanced effective communication skills such as saying no, maintaining and improving self-esteem and self-love.
Category: Treatment - Other

2

Description: The second intervention group: 20 one-hour sessions once a week will receive the combination of dialectical behavior therapy intervention and desensitization with eye movements and reprocessing. The goals of therapy sessions include teaching relaxation techniques and basic skills of awareness, practice of achieving complete focus on the present moment, identifying thoughts in the continuation of practicing advanced skills of attention, familiarization with basic and advanced skills of tolerating disturbance,Community Verified icon, Necessary training on how to treat eye desensitization through eye movement and reprocessing and recalling relaxation techniques, using appropriate metaphors, for example, imagining seeing traumatic scenes like watching them through a television or seeing these scenes through a train window that The client sits in it and looks at the scenery outside the train.In the continuation of the desensitization stage, which includes helping the clients to focus on the mental images of disturbing scenes, negative beliefs and emotions and bodily feelings, and bilateral stimulation of the brain through the client's eye movements in following the therapist's movements, in the continuation of the coding and training stage Physical examination, the next steps include basic and advanced skills of emotion regulation as well as basic and advanced skills of effective communication.
Category: Treatment - Other

3

Description: For the control group, a pre-test will be performed at first, but they will not receive any intervention during the treatment, however, to respect their rights, they will remain on the waiting list, and at the end of the study and after the final evaluations, they will have the opportunity to receive one of the similar treatment interventions. Intervention groups will be provided for them.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Clinic of Ibn Sina Hospital

Full name of responsible person

Laila Hafazi Torghabeh

Street address

Horameli St., next to Astan Quds Razavi

City

Mashhad

Province

Razavi Khorasan

Postal code

919583134

Phone

+98 51 3711 2701

Email

leilahefazi68@gmail.com

1

Sponsor: Name of organization / entity

Semnan University Research Assistant

Full name of responsible person

Mohammad Hossein Ehsani

Street address

Facing Sokan Park - Central Organization of Semnan University

City

Semnan

Province

Semnan

Postal code

3513119111

Phone

+98 23 3383 1456

Email

ehsani@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Semnan University Research Assistant
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

Semnan University

Full name of responsible person

Laila Hafazi Torghabeh

Position

PhD student Psychology

Latest degree

Master

Other areas of specialty/work

Psychology

Street address

Ahmedabad, between three ways of guidance and Shirin alley, Mir building, unit 118

City

Mashhad

Province

Razavi Khorasan

Postal code

9351914953

Phone

+98 51 3841 5553

Email

leilahefazi68@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Semnan University

Full name of responsible person

Mahmoud Najafi

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Psychology

Street address

Semnan- Mahdishahr, Darband, Mahdishahr Faculty of Psychology and Educational Sciences, Semnan University

City

semnan

Province

Semnan

Postal code

3564111556

Phone

+98 915 323 5160

Email

m_najafi@semnan.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Semnan University

Full name of responsible person

Leila Hefazi Torghabeh

Position

PhD student Psychology

Latest degree

Master

Other areas of specialty/work

Psychology

Street address

Ahmedabad, between three ways of guidance and Shirin alley, Mir building, unit 118

City

Mashhad

Province

Razavi Khorasan

Postal code

9351914953

Phone

+98 518415553

Email

leilahefazi68@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: All data can be shared after de-identifying people, provided that the people who want the data give a letter of introduction to the university.
When the data will become available and for how long: Starting to be able to access the data 6 months after the results are published
To whom data/document is available: The data will be available to researchers working in scientific and academic institutions
Under which criteria data/document could be used: All data can be shared after de-identifying people, provided that the people who want the data give a letter of introduction to the university.
From where data/document is obtainable: All data can be shared after de-identifying people, provided that the people who want the data give a letter of introduction to the university.
What processes are involved for a request to access data/document: The introduction letter will be submitted by the university to the Ethics Committee of the University of Medical Sciences and will be made available to the individuals if the data is approved
Comments

A Comparison of the Effectiveness of Dialectical Behavior Therapy (DBT) With and Without Eye Movement Desensitization and Reprocessing (EMDR) on Mentalization, Emotion Regulation, Psychological Distress, and Suicidal Ideation in Individuals with Borderline Personality Disorder (BPD)