Comparison of the efficacy of schema therapy with mentalization in patients with borderline personality disorder
Design
Clinical trial, parallel groups, phase three, unblinded, randomized, which will be conducted on 40 patients.
Settings and conduct
The studied population is 40-18 years old patients with borderline personality disorder referring to affiliated clinics of the University of Medical Sciences. The patients will be randomly entered into the study by the random number table method by the computer and the intervention will be performed on them.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: patients with borderline personality disorder; At least sixth grade education; Age 18 to 40 years
Exclusion Criteria: patients with psychotic and organic brain disorders; participation in other psychotherapy programs; intellectual disability; Cognitive disorders; Bipolar disorder; Drug use during intercourse
Intervention groups
Mentalization based treatment (MBT) group: treatment sessions according to the treatment protocol of Batman and Fonagy to 12 sessions of preliminary mindfulness-based therapy (MBT-I) and then 8 sessions of group mindfulness-based therapy (MBT-G) on a weekly basis Each session will last 75 minutes.
Group therapy based on schema therapy (ST): according to the protocol, 15 sessions of 60-120 minutes will be conducted weekly.
Main outcome variables
Total score of borderline personality disorder index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230130057281N1
Registration date:2023-07-19, 1402/04/28
Registration timing:prospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Alireza Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4719
Email address
a.azizi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of schema therapy with mentalization in patients with borderline personality disorder
Public title
Effectiveness of schema therapy with mentalization in patients with borderline personality disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with borderline personality disorder
At least sixth grade education
Age 18 to 40 years
Exclusion criteria:
Patients with psychotic and organic brain disorders
Participation in other psychotherapy programs
Intellectual disability
Cognitive disorders
Bipolar disorder
Drug use at the time of the interview
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using permutation blocks of size 4. Patients will be randomly assigned to two groups of 15 using 10 blocks of size 4 and 1:1 ratio. Creation of random allocation sequence in blocks will be done by statistician.
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 Babol University of Medical Siences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.MUBABOL.REC.1402.027
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
Total score of borderline personality disorder index
Timepoint
Before starting the treatment, immediately after the end of the sessions and 2 months after the end of the sessions
Method of measurement
Borderline personality disorder questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mentalization based treatment (MBT) group treatment sessions according to the treatment protocol of Batman and Fonagy to 12 sessions of preliminary mindfulness-based therapy (MBT-I) and then 8 sessions of group mindfulness-based therapy (MBT-G) on a weekly basis Each session will last 75 minutes.
Category
Treatment - Other
2
Description
Intervention group: Group therapy based on schema therapy (ST) according to the protocol, 15 sessions of 60-120 minutes will be conducted weekly..
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Alireza Azizi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
nedafathi@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Yahyanezhad Hospital
Full name of responsible person
Alireza Azizi
Street address
Shahid Yaheinejad Hospital, Shahid Mustafa Khomeini Street, Modares Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3222 3594
Email
nedafathi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
m.rajabnia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Babol University of Medical Sciences
Full name of responsible person
Alireza Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
nedafathi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Alireza Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3233 8301
Email
nedafathi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Alireza Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3233 8301
Email
nedafathi@yahoo.com
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
There is still no plan for its publish.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available