Protocol summary

Study aim
The purpose of this study was to compare the effectiveness of emotion regulation skills training based on Gross Model and Linehan Model on emotion regulation strategies, emotional cascade and suicidal thoughts in adolescents with borderline personality disorder
Design
In this study, 45 adolescents with borderline personality disorder with inclusion criteria who were referred to counseling and psychology centers, psychiatric services as well as suicide emergency centers in Tehran, were selected. Participants were randomly divided into two experimental and one control groups.
Settings and conduct
The place of study was two psychological clinics in Tehran. After the random allocation of experimental groups, training was carried out in these two clinics.
Participants/Inclusion and exclusion criteria
Age between 15 and 19 years, Lack of comorbid mood disorders (bipolar, major depression), Minimum First Level Education, Having at least one suicide attempt, With clinical symptoms of borderline personality disorder criteria based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, At the time of entering the program, A year earlier the disorder is diagnosed. Conditions of failure to enter: substance abuse, psychotic disorders, under other psychological treatments and under medication.
Intervention groups
Includes two experimental groups; one of them received Linehan's Model Emotion Regulation skills training , and the other group received Gross's Model Emotion Regulation skills training. The control group did not receive any intervention.
Main outcome variables
Preventing self-harming behaviors, such as suicide and self-harm, in adolescents with borderline personality disorder, helping clinicians and mental health professionals to get conceptualization of the patient's problem.

General information

Reason for update
Acronym
BPD
IRCT registration information
IRCT registration number: IRCT20171225038062N1
Registration date: 2018-02-13, 1396/11/24
Registration timing: retrospective

Last update: 2018-02-13, 1396/11/24
Update count: 0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Seyede Samera Hoseini Omam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7763 9333
Email address
samera.hoseini@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-08, 1396/04/17
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
2017-07-08, 1396/04/17
Actual recruitment end date
2017-10-22, 1396/07/30
Trial completion date
empty
Scientific title
Compare the Effectiveness of Emotion Regulation Skills Training based on Gross Model and Linehan Model on Emotion Regulation Strategies, Emotional Cascade and Suicidal Toughts in Adolescents with Borderline Personality Disorder
Public title
The Effectiveness of Two Models Emotion Regulation Skills Training in Adolescents with Borderline Personality Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum First Level Education Lack of comorbid mood disorders (bipolar, major depression) Having at least one history of suicide attempt With clinical symptoms of borderline personality disorder It's been a year since the disorder diagnosis
Exclusion criteria:
Substance abuse Psychotic disorders Under other psychological treatments Under medication
Age
From 15 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
In this study has been used Random allocation rule. 45 adolescents who referred to counseling and psychology centers, psychiatric services as well as suicide emergency centers in Tehran were randomly entered to experimental and control groups using a draw container.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants who were adolescents with borderline personality disorder did not know about the allocation of study groups.
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
Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
99951 35198
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.SEMUMS.REC.1396.168

Health conditions studied

1

Description of health condition studied
Borderline Personality Disorder
ICD-10 code
F60.3
ICD-10 code description
اختلال شخصیت ناپایدار هیجانی

Primary outcomes

1

Description
Score of Emotion regulation strategies in Cognitive Emotion Regulation Questionnaire (CERQ)
Timepoint
Before the intervention begins and after the end of the intervention
Method of measurement
Cognitive Emotion Regulation Questionnaire (CERQ)

2

Description
Score of Emotional Cascade in Distress Tolerance Scale and Thought Suppression Questionnaire
Timepoint
Before the intervention begins and after the end of the intervention
Method of measurement
Distress Tolerance Scale and Thought Suppression Questionnaire

3

Description
Score of suicidal thoughts in Beck Scale for Suicide Ideation
Timepoint
Before the intervention begins and after the end of the intervention
Method of measurement
Beck Scale for Suicide Ideation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Includes experimental group ( 15 in the emotion regulation skills training based on Linehan model). For the purposes of research before the intervention begins, the subjects were given Cognitive Emotion Regulation Questionnaire, Beck Scale for Suicide Ideation, Distress Tolerance Scale, Thought Suppression Questionnaire a questionnaire. After the end of the intervention, the questionnaires were again given to the participants.
Category
Behavior

2

Description
Intervention group 2: Includes experimental group ( 15 in the emotion regulation skills training based on Gross model). For the purposes of research before the intervention begins, the subjects were given Cognitive Emotion Regulation Questionnaire, Beck Scale for Suicide Ideation, Distress Tolerance Scale, Thought Suppression Questionnaire a questionnaire. After the end of the intervention, the questionnaires were again given to the participants.
Category
Behavior

3

Description
Control group: The control group received no intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialist Psychology and Consultation Center Rahaee
Full name of responsible person
Mojgan Salavati
Street address
No. 16, Ketabi Ave., Ketabi Sq., Qitariye., Specialist Psychology and Consultation Center Rahaee
City
Tehran
Province
Tehran
Postal code
1938813870
Phone
+98 21 2221 7904
Email
mojgansalavati47@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Psychology & Educational sciences Mahdishahr
Full name of responsible person
Isaac Rahimian Boogar
Street address
Faculty of Psychology & Educational sciences Mahdishahr , Semnan University , Darband, Mehdishahr, Semnan, Iran
City
Mehdishahr
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 3300
Email
e_rahimian@sun.semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Psychology & Educational sciences Mahdishahr
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
Faculty of Psychology & Educational sciences Mahdishahr
Full name of responsible person
Mahmood Najafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology & Educational sciences Mahdishahr , Semnan University , Darband, Mehdishahr, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 3300
Fax
Email
m_najafi@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyede Samera Hoseini Omam
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 18, Hoghoghi Ave., Shariati Ave., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1611994111
Phone
+98 21 7763 9333
Fax
Email
samera.hoseini@semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Seyede Samera Hoseini Omam
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 18, Hoghghi Ave, Shariari Ave, Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1611994111
Phone
+98 21 7763 9333
Email
samera.hoseini@semnan.ac.ir

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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Information on the main outcomes of the study is available for sharing.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Mental health therapists
Under which criteria data/document could be used
Psychologists
From where data/document is obtainable
Seyede Samera Hoseini Omam
What processes are involved for a request to access data/document
A clear explanation of why the documentation is needed. Because the principle of confidentiality is very important in cases of suicide, therefore, caution will be given in certain circumstances.
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