Protocol summary

Study aim
Comparison of the effectiveness of analytical psychotherapy based on object relationships and commitment and acceptance therapy based on personality organization, neuroticism, defensive styles, impulsivity and identity styles of people with borderline personality disorder.
Design
All patients referred to the outpatient department of Zare Psychiatric Hospital in Sari city and the treatment clinic of Maneh House in Sari city who have borderline personality disorder. Selected by available sampling. In this way, a structured interview for SCID-5-PD personality disorders was taken among the people who referred to the clinic of Zare Hospital in Sari and the treatment clinic of Maneh House in Sari due to behavioral problems and was confirmed by a psychiatrist. There are 12 people in each group, 6 for object relationship psychotherapy (focus on transfer) and 6 for commitment and acceptance psychotherapy.
Settings and conduct
The study was performed in Shari city clinic and was held once a week
Participants/Inclusion and exclusion criteria
1- Having a diagnosis of borderline personality disorder: a) by a psychiatrist b) by a structured clinical interview questionnaire for personality disorders 2- Being at least 20 and at most 40 years old 3- Having at least a diploma 4 - No serious thoughts of harm to yourself or others 5- Absence of psychosis 6- Absence of restrictive and chronic physical disorders (chronic liver, kidney and heart failure)
Intervention groups
Transference-oriented psychotherapy intervention consists of 50 individual sessions with the aim of transference-oriented TFP psychotherapy. Acceptance and commitment therapy intervention consisted of 40 individual sessions using specific ACT techniques.
Main outcome variables
organization of personality, impulsivity, defensive and mental styles.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131007014928N7
Registration date: 2021-03-23, 1400/01/03
Registration timing: prospective

Last update: 2021-03-23, 1400/01/03
Update count: 0
Registration date
2021-03-23, 1400/01/03
Registrant information
Name
Mehdi Pourasghar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3327 3024
Email address
m.pourasghar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-04, 1399/12/14
Expected recruitment end date
2021-04-03, 1400/01/14
Actual recruitment start date
2021-04-08, 1400/01/19
Actual recruitment end date
2021-04-19, 1400/01/30
Trial completion date
2021-04-19, 1400/01/30
Scientific title
Comparison of the effectiveness of psychoanalytic psychotherapy based on object relationships and Acceptance and commitment therapy (Act) on personality organization, neuroticism, defensive styles and impulsivity of individuals with borderline personality disorder
Public title
Comparison of the effectiveness of psychoanalytic psychotherapy based on object relationships and Acceptance and commitment therapy (Act) on personality organization, neuroticism, defensive styles and impulsivity of individuals with borderline personality disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Having a diagnosis of borderline personality disorder: a) by a psychiatrist b) by a structured clinical interview questionnaire for personality disorders 2- Being at least 20 and at most 40 years old 3- Having at least a diploma 4 - No serious thoughts of harm to yourself or others 5 - No psychosis 6- Absence of restrictive and chronic physical disorders (chronic liver, kidney and heart failure)
Exclusion criteria:
1- The occurrence of thoughts of self-harm or uncontrollable others during treatment 2- Occurrence of delusional disorders or other cognitive disorders during treatment 3- Tendency to leave the plan at any stage of treatment
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: 6
Actual sample size reached: 6
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Accident, By drawing lots, she writes the names of the people on a piece of paper, pours them into two containers, then puts each piece of paper in a treatment, and finally the names are opened and selected for each treatment.
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
birjand university of medical sciences
Street address
South Khorasan, Birjand, Ghaffari St., Central Organization of Birjand University of Medical Sciences
City
birjand
Province
North Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2020-08-16, 1399/05/26
Ethics committee reference number
IR.BUMS.REC.1399.245

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
Personality Organization
Timepoint
Beginning of the study, Session 20, End of the study, Two months follow-up
Method of measurement
Kornberg Personality Organization Questionnaire

2

Description
Impulsivity
Timepoint
Beginning of the study, Session 20, End of the study, Two months follow-up
Method of measurement
Bartlett Impulsivity Questionnaire

3

Description
Defensive Styles
Timepoint
Beginning of the study, Session 20, End of the study, Two months follow-up
Method of measurement
Defense Styles Questionnaire

4

Description
neuroticism
Timepoint
Beginning of the study, Session 20, End of the study, Two months follow-up
Method of measurement
Neo Five Personality Factors Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Transference-oriented psychotherapy intervention group includes 50 individual sessions with the aim of TFP-focused psychotherapy of identity consolidation.(Integrating the relationships of annoying and idealized internal objects isolated in transmission in order to achieve a consistent, realistic, and coherent experience of self and others)This inner state of identity consolidation is associated with the regulation of emotion and positive relationships based on cooperation with others
Category
Treatment - Other

2

Description
Intervention group: The acceptance and commitment therapy intervention group consisted of 40 individual sessions using specific ACT techniques.The main purpose of ACT is to increase psychological flexibility.This implies life skills in the present moment to perform behaviors that fit the patient's values.Psychological flexibility is created through ACT processes.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zare Hospital Sari
Full name of responsible person
Dr Mehdi Pourasghar
Street address
7 km Sari Road to Neka
City
Sari
Province
Mazandaran
Postal code
4816788888
Phone
+98 11 3328 3886
Email
zarehospital@yahoo.com

2

Recruitment center
Name of recruitment center
Khane Mana
Full name of responsible person
Fatemeh Fathi
Street address
Farhang St., 15 Khordad St., Mahtab Alley, above Resalat Bank, 6th floor
City
Sari
Province
Mazandaran
Postal code
4763768897
Phone
+98 11 3325 5178
Email
fatemeh_fathi67@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Aliabadi
Street address
Birjand, at the end of Ayatollah Ghaffari Boulevard
City
Birjand
Province
South Khorasan
Postal code
4763833730
Phone
Email
aliabadi@iaubir.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University Birjand Branch
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahram Vaziri
Position
Associate Professor, Faculty Member, Islamic Azad University, Roodehen Branch
Latest degree
Subspecialist
Other areas of specialty/work
Psychology
Street address
Roodehen - University Complex
City
Rodehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
۰۲۱-۷۶۵۰۵۰۱۵۲۴
Email
shahram.vaziri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Pourasghar
Position
Associate Professor, Faculty of Mazandaran University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Sari, Imam Square, Joybar Three Ways, beginning of Valiasr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
۱-۳۳۰۴۴۰۰۰-۰۱۱
Email
me_pourasghar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Birjand Branch
Full name of responsible person
Fatemeh Fathi
Position
Non-Faculty Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Elegance Street Elegance Street Cheshmeh Alley Second dead end on the Right
City
Ghaemshahr
Province
Mazandaran
Postal code
4763833730
Phone
42076872
Email
fatemeh_fathi67@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
The data is completely personal and contrary to professional ethics
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Statistical documents are available
When the data will become available and for how long
nothing
To whom data/document is available
Statistical data are available but patient records are personal
Under which criteria data/document could be used
Statistical documents are available
From where data/document is obtainable
Receiving the patient's personal file is not available for ethical reasons
What processes are involved for a request to access data/document
nothing
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