Protocol summary

Study aim
Effectiveness of group therapy based on mentalization and dialectical behavior on attachment styles, mentalization, social cognition, and clinical symptoms in patients with borderline personality disorder
Design
The research method in this study is pre-test type, post-test and two-month follow-up true experimental design with control group. Placing in groups is random.
Settings and conduct
The intervention was carried out at Hafez Hospital. The intervention was performed in the daily hospital. Meetings were held twice a week. Participants were randomly assigned to groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1) age range 18 to 25 2) having at least primary school education 3) having received diagnosis of borderline personality disorder based on DSM5 4) get diagnosis of borderline personality disorder as a primary diagnosis; Exclusion criteria 1)substance dependency (but not substance abuse) 2)psychiatric admission during treatment 3)receive any other psychotherapy
Intervention groups
All three groups receive drug therapy. Interventtion group 1: In addition to medication, receives a group therapy based on mentalization. Interventions lasted 10 weeks. sessions were held twice a week and every session last two hours. Interventtion group 2: In addition to medication, receives group therapy based on dialectical behavioral. Interventions lasted 10 weeks. sessions were held twice a week and every session last two hours. Control group: Just receive drug therapy. No individual or group psychotherapy intervention.
Main outcome variables
borderline personality disorder severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190417043303N1
Registration date: 2019-06-08, 1398/03/18
Registration timing: retrospective

Last update: 2019-06-08, 1398/03/18
Update count: 0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Leila Khabir
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 71 3822 9388
Email address
l.khabir@shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-07, 1396/12/16
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
2018-03-07, 1396/12/16
Actual recruitment end date
2018-06-21, 1397/03/31
Trial completion date
2019-02-19, 1397/11/30
Scientific title
Group therapy based on mentalization and dialectical behavior on attachment styles, mentalization, social cognition, and clinical symptoms in patients with borderline personality disorder
Public title
Group therapy based on mentalization and dialectical behavior in patients with borderline personality disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age range 18 to 25 having at least primary school education having received diagnosis of borderline personality disorder based on DSM5 get diagnosis of borderline personality disorder as a primary diagnosis
Exclusion criteria:
substance dependency (but not substance abuse) psychiatric admission during treatment receive any other psychotherapy
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
To perform the division (conventionally) the intervention groups and control group were named A, B and C. Then, 60 numbers of the random numbers table were selected by computer; if the first number was between 1 to 3 it was identified as A (MBT intervention group), first numbers from 4 to 6 were identified as B (DBT intervention group), and first numbers from 7 to 9 were identified as C (control 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
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.SUMS.REC.1397.639

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
borderline personality disorder severity
Timepoint
before, immediately and two month after the intervention
Method of measurement
borderline personality disorder severity index

Secondary outcomes

1

Description
attachment styles
Timepoint
before, immediately and two month after the intervention
Method of measurement
Revised Adult Attachment Scale

2

Description
mentalization
Timepoint
before, immediately and two month after the intervention
Method of measurement
Reflective Functioning Questionnaire

3

Description
social cognition
Timepoint
before, immediately and two month after the intervention
Method of measurement
‘Reading the Mind in the Eyes’’ Test Revised Version

Intervention groups

1

Description
First intervention group: group therapy based on mentalization: The aim of treatment based on mentalization is to establish balance in problems of patients with borderline personality disorder by enhancing the ability to be aware of mental status under anxiety conditions and to activ their secure attachment style. Interventions lasted 10 weeks. sessions were held twice a week and every session last two hours. Sessions contain: Concept of mentalization, The concept of problems with mentalizing, Why do we have emotions and what are the basic types?, How do we register and regulate emotions? Relationship between mentalising and emotions., The significance of attachment relationships?, Relationship between attachment and mentalization, The concept of personality disorder and borderline personality disorder, Mentalization-based treatment. Relationship among Anxiety, attachment and mentalizing, Relationship among Depression, attachment and mentalizing.
Category
Treatment - Other

2

Description
Second intervention group: group therapy based on dialectical behavior: This treatment was developed to work with patients with borderline personality who had a history of suicide and not improved by conventional cognitive behavioral therapy. This treatment is based on the acquisition of skills and behavioral shaping. Interventions lasted 10 weeks. sessions were held twice a week and every session last two hours. Session contain some skills in domain mindfulness, emotion regulation, distress tolerance and relationship effectiveness. Mindfulness skills such as: training state of mind, paying attention to what the world, body and mind is doing, paying all of your attention to one thing at a time. Distress tolerance skills such as: explain about distress tolerance goals, use of distracting, calming yourself and thinking about your choices for surviving bad times, use of breathing, smiling and focusing in accepting reality. Emotion regulation skills such as: explain about emotion regulation, identifying emotions, benefit of emotions, keeping control of your emotions, change how you feel by acting differently. Relationship effectiveness skills such as: explain about goals of relationship effectiveness, the reason of use relationship effectiveness skills, keeping good relationships.
Category
Treatment - Other

3

Description
Control group: no psychological intervention: Subjects in this group did not receive psychological interventions individually or in groups.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Leila Khabir
Street address
Hafez hospital., Chamran Blv
City
Shiraz
Province
Fars
Postal code
71946-34786
Phone
+98 71 3647 9203
Email
hafezhospt@sums.ac.ir

2

Recruitment center
Name of recruitment center
Ebnesina hospital
Full name of responsible person
Leila Khabir
Street address
Ebnesina hospital, Hafez street
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3228 9600
Email
info@ebnesinahospital.com

3

Recruitment center
Name of recruitment center
Center of Shiraz University Counseling and Psychotherapy
Full name of responsible person
Leila Khabir
Street address
Center of Shiraz University Counseling and Psychotherapy, Neshat street
City
Shiraz
Province
Fars
Postal code
71964-84334
Phone
+98 71 3647 3398
Email
shirazcounseling@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University
Full name of responsible person
Seyed Mojtaba Zebarjad
Street address
Dept. of Clinical Psychology, Faculty of Education and Psychology, Shiraz University, Eram square
City
Shiraz
Province
Fars
Postal code
71964-84334
Phone
+98 71 3628 6426
Email
mojtabazebarjad@shirazu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University
Full name of responsible person
Leila Khabir
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Dept. of Clinical Psychology, Faculty of Education and Psychology, Shiraz University
City
Shiraz
Province
Fars
Postal code
71964-84334
Phone
+98 71 3822 9388
Email
leilakhabir@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Leila Khabir
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Education and Psychology, Shiraz University, Eram Square
City
Shiraz
Province
Fars
Postal code
۷۱۹۶۴-۸۴۳۳۴
Phone
+98 6134653
Email
l.khabir@shirazu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Leila Khabir
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Education and Psychology, Shiraz University, Eram Square
City
Shiraz
Province
Fars
Postal code
۷۱۹۶۴-۸۴۳۳۴
Phone
+98 71 3613 4653
Email
l.khabir@shirazu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
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
No - There is not 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
Loading...