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Comparing the Effectiveness of Face-to-face Cognitive Behavioral Therapy and Internet-Based Cognitive Behavioral Therapy in People with Dependent Personality Disorder

Protocol summary

Study aim
Comparing the Effectiveness of Face-to-face Cognitive Behavioral Therapy and Internet-Based Cognitive Behavioral Therapy in Dependent Personality Disorder symptoms
Design
Clinical trial, Randomized, on 30 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In this research, after receiving the code of ethics from Shahid Beheshti University of Medical Sciences ethics committee, the sample people are selected based on the Inclusion criteria and then after the initial interview according to SCID-5-RV, (SCID-5-PD), (SCID 5-SPQ) and declaring their willingness to participate in the meetings, explanations about the research are given to them. All participants complete the (DASS-21) and (IIP-32) questionnaires before starting the treatment during the introductory session and then immediately after the course.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primary diagnosis of Dependent Personality Disorder, Exclusion criteria: had a diagnosis of antisocial, schizotypal, schizoid, and borderline personality disorder, were at high risk of suicide.
Intervention groups
Intervention group 1 and 2: all clients to psychological treatment centers in Tehran, which for 15 sessions once a week for 60 minutes, intervention group 1 underwent face-to-face cognitive behavioral therapy (cbt) and intervention group 2 underwent Internet-Based cbt (according to the book of Cognitive Behavior Therapy of DSM-5 Personality Disorders, Assessment, Case Conceptualization, and Treatment). The content of the sessions: assessment and socialization with therapy, teaching behavioral and cognitive interventions, and teaching the patient to categorize distorted spontaneous thoughts and challenging spontaneous thoughts and related dysfunctional schemas.
Main outcome variables
Depression, Anxiety, Stress ؛Interpersonal Problems

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211223053494N5
Registration date: 2023-06-03, 1402/03/13
Registration timing: prospective

Last update: 2023-06-03, 1402/03/13
Update count: 0
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Jafar Sarani yaztappeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 1334 1894
Email address
sarani.jafar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Face-to-face Cognitive Behavioral Therapy and Internet-Based Cognitive Behavioral Therapy in People with Dependent Personality Disorder
Public title
Effectiveness of Cognitive Behavioral Therapy in Dependent Personality Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age range of 18-65 years, primary diagnosis of Dependent Personality Disorder, were fluent in Persian.
Exclusion criteria:
Having current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia spectrum disorder, bipolar I disorder, neurocognitive disorder, and substance-related disorder had a diagnosis of antisocial, schizotypal, schizoid, and borderline personality disorder were at high risk of suicide had a history of Cognitive behavioral therapy for the last four years
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple randomization. The randomization unit is individual. Excel software is used for randomization. Subjects will be randomly assigned to two groups, intervention group 1 and intervention group 2, based on the randomization part of Excel. In this way, all the names are entered into Excel and we will create a random number in Excel using the Random Number Generation option in the Toolback Analysis section. Even numbers are in intervention group 1 and odd numbers are in intervention group 2.
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
Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, next to the University Headquarters, Shahid Beheshti University of Medical Sciences, Shahid Chamran Evin Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.SBMU.MSP.REC.1402.060

Health conditions studied

1

Description of health condition studied
Dependent personality disorder
ICD-10 code
F60.7
ICD-10 code description
Dependent personality disorder

Primary outcomes

1

Description
Depression, anxiety and stress score in Lovibond and Lovibond scale (DASS-21)
Timepoint
At the beginning of the study (before the intervention), after the intervention
Method of measurement
Depression, Anxiety, Stress Scale (DASS-21)

2

Description
Score of interpersonal problems in Barkham questionnaire
Timepoint
At the beginning of the study (before the intervention), after the intervention
Method of measurement
Inventory of Interpersonal Problems (IIP-32)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: includes all clients to psychological treatment centers in Tehran who received face-to-face cognitive behavioral therapy (according to the book of Cognitive Behavior Therapy of DSM-5 Personality Disorders, Assessment, Case Conceptualization, and Treatment) for 15 sessions once a week for 60 minutes. The content of the first to third sessions: assessment and Socialization with treatment, behavioral and cognitive intervention training, the content of the fourth to eighth sessions of behavioral intervention training, including assertiveness and communication skills training. Cognitive skills include teaching and practicing problem-solving skills, teaching autonomy and self-control, emotional skills-emotional inhibition and division of emotions; Perceptual skills of having a wide view, stopping thinking, distancing emotionally, physiological skills such as relaxation training and meditation. and performing graded tasks, teaching the connection between spontaneous thoughts and the patient's feelings, teaching the patient to categorize distorted spontaneous thoughts and challenging spontaneous thoughts and dysfunctional schemas related to dependency and disability. The content of the 9th to 15th sessions is the continuation of behavioral and cognitive interventions to identify and challenge spontaneous thoughts during the treatment sessions and preparation for the end of the sessions.
Category
Treatment - Other

2

Description
Intervention group 2: includes all clients to psychological treatment centers in Tehran who individually received Internet-Based Cognitive Behavioral Therapy (according to the book of Cognitive Behavior Therapy of DSM-5 Personality Disorders, Assessment, Case Conceptualization, and Treatment) for 15 sessions once a week for 60 minutes. The content of the first to third sessions: assessment and Socialization with treatment, behavioral and cognitive intervention training, the content of the fourth to eighth sessions of behavioral intervention training, including assertiveness and communication skills training. Cognitive skills include teaching and practicing problem-solving skills, teaching autonomy and self-control, emotional skills-emotional inhibition and division of emotions; Perceptual skills of having a wide view, stopping thinking, distancing emotionally, physiological skills such as relaxation training and meditation. and performing graded tasks, teaching the connection between spontaneous thoughts and the patient's feelings, teaching the patient to categorize distorted spontaneous thoughts and challenging spontaneous thoughts and dysfunctional schemas related to dependency and disability. The content of the 9th to 15th sessions is the continuation of behavioral and cognitive interventions to identify and challenge spontaneous thoughts during the treatment sessions and preparation for the end of the sessions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Jafar Sarani Yaztappeh
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1548
Email
sarani.jafar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsin Zarghi
Street address
Vice-Chancellor of Research Affairs,Shahid Beheshti University of Medical Sciences, Next to Taleghani hospital, Erabi Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hoda Doos Ali Vand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2303 1548
Email
doosalivand.h@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hoda Doos Ali Vand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2303 1548
Email
doosalivand.h@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jafar Sarani Yaztappeh
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1548
Email
sarani.jafar@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 no more information.
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
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
No - There is not a plan to make this available
Title and more details about the data/document
The main report will publish in appropriate articles
When the data will become available and for how long
6 Months after Article Publication
To whom data/document is available
Only for Scientific and Academic Researchers
Under which criteria data/document could be used
Only for Analysis and Researches around the main topic of this study
From where data/document is obtainable
Contact with Mr. Jafar Sarani Yaztappeh by this email address: sarani.jafar@yahoo.com
What processes are involved for a request to access data/document
Documents will send to his email address, approximately 2 month after request.
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