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The applicability and efficacy of Transdiagnostic cognitive behavior therapy on reducing signs and symptoms of Borderline Personality Disorder with co-occuring emotional disorders

Protocol summary

Summary
The aim of this study, as an outcome/process research, is to examine the applicability and efficacy of Transdiagnostic Cognitive Behavior Therapy on reducing signs and symptoms of Iranian patients with BPD and co-occurring emotional disorders. Inclusion criteria are: a) age above 18, b) Borderline Personality disorder (BPD), and c) another emotional disorder as a comorbid disorder. Exclusion criteria are: a) presence of diagnostic criteria for psychotic disorder/bipolar disorder/ drug abuse or dependency in the time of research, b) risk of imminently suicidal attempt. By purposeful sampling method, six volunteer patients with Borderline Personality Disorder who met in/exclusion criteria, will participate in a multiple baseline experimental single case study. Participants are recruited from Clinical Psychology and Psychiatry Clinics of Taleghani Hospital and Counselling Center of Tehran University, Tehran, Iran. Each participant will complete the Borderline Personality Inventory (BPI), the Difficulties in Emotion Regulation Scale (DERS), the Positive and Negative Scale (PANAS), the Work and Social Adjustment Scale (WASA), the Affective Lability Scale (ALS), the Toronto Alexithymia Scale (TAS) during 3 baseline, 8 treatment modules and 1 follow up assessments sessions. The unified protocol will be carried out for 16-20 weekly 50 minute sessions. The expected conclusion is deduction of BPD and comorbid disorders symptoms and improvement of emotion regulation skills.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110524899N1
Registration date: 2016-11-10, 1395/08/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-10, 1395/08/20
Registrant information
Name
Farzane Mohamadi
Name of organization / entity
Shahid Beheshti University of Medical Sciences (SBMU)
Country
Iran (Islamic Republic of)
Phone
+98 93038129162
Email address
fmohammadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
This research is funded by Shahid Beheshti University of Medical Sciences (SBMU).
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The applicability and efficacy of Transdiagnostic cognitive behavior therapy on reducing signs and symptoms of Borderline Personality Disorder with co-occuring emotional disorders
Public title
Unified protocol for the transdiagnostic treatment of borderline personality disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: a) age above 18, b) Borderline Personality disorder (BPD) based on psychiatric diagnostic interview by psychiatrist and SCID-II by clinical psychologist, and c) another emotional disorder as a comorbid disorder based on psychiatric diagnostic interview by psychiatrist and SCID-I by clinical psychologist. Exclusion criteria are: a) presence of diagnostic criteria for psychotic disorder/bipolar disorder/ drug abuse or dependency in the time of research, b) risk of imminently suicidal attempt.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 6
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
IR.SBMU.SM.REC.1394.
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.SBMU.SM.REC.1394.26

Health conditions studied

1

Description of health condition studied
Borderline personality disorder
ICD-10 code
F60.3
ICD-10 code description
Emotionally unstable personality disorder

2

Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode

3

Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
Diagnostic Recovery
Timepoint
pre-post treatment
Method of measurement
SCHID-II

2

Description
Emotion Regulation
Timepoint
pre-post treatment & after each module
Method of measurement
Difficulties in Emotion Regulation Scale(DERS)

3

Description
Alexithymia
Timepoint
pre-post treatment
Method of measurement
Toronto Alexithymia Scale (TAS-20)

4

Description
General function
Timepoint
pre-post treatment
Method of measurement
Work and Social Adjustment Scale (WSAS)

5

Description
Depression
Timepoint
pre-post treatment & after each module
Method of measurement
Depression Anxiety Stress Scale -42

6

Description
Anxiety
Timepoint
pre-post treatment & after each module
Method of measurement
Depression Anxiety Stress Scale -42

7

Description
Affect Intensity
Timepoint
pre-post treatment
Method of measurement
Affect Intensity Measure (AIM)

8

Description
Affective Lability
Timepoint
pre-post treatment
Method of measurement
Affective Lability Scale (ALS)

Secondary outcomes

empty

Intervention groups

1

Description
Patients will participate in 16-20 weekly transdiagnostic cognitive behavior treatment sessions.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinical Psychology and Psychiatry Clinics of Taleghani Hospital
Full name of responsible person
Mrs. Mohammadi
Street address
Clinical Psychology Clinic, Taleghani Hospital, Evin Squ, Tehran, Iran.
City
Tehran

2

Recruitment center
Name of recruitment center
Counselling center of Tehran University
Full name of responsible person
Mrs. Issac
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research of Medicine School of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mrs Khateri
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Medicine School of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Mohamadi
Position
Ph.D Candidate of Clinical Psychology
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 903 812 9162
Fax
Email
farzanehmohammadi86@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences(SBMU)
Full name of responsible person
Dr. Maryam Bakhtiari
Position
Associate of Clinical Psychology
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 912 277 7387
Fax
Email
dr.m.bakhtiari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Mohamadi
Position
Ph.D Candidate of Clinical Psychology
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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