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Comparing the effectiveness of cognitive-behavioral therapy with combined cognitive-behavioral therapy (face-to-face + web-based application) university students' maladaptive perfectionism

Protocol summary

Study aim
The purpose of the study is to compare the effectiveness of cognitive-behavioral therapy with combined cognitive-behavioral therapy (in-person+web-based application) on university students' maladaptive perfectionism
Design
Random clinical trial with parallel groups, without blindness, on 46 students with maladaptive perfectionism
Settings and conduct
The location ofstudy,University counseling centers orPublic and private psychological and counseling clinics provide psychological services. Students who have Criteria for entering the research will be randomly placed in one of the two groups of cognitive-behavioral or Combined cognitive-behavioral therapy (face to face+web-based app)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Includes students of 18 to 35 years old, with maladaptive perfectionism, internet access and smartphones. Exclusion criteria include symptoms of psychosis, autism spectrum disorder, bipolar disorders and other related disorders, addictive and Substance-related disorders, Simultaneous participation in other psychotherapies
Intervention groups
Cognitive-Behavioral Therapy Group: They will receive 10 face-to-face individual therapy sessions, once a week, which will last for 45 minutes.Combined Cognitive-Behavioral Therapy Group (face to face+Web-based appication): 1They will receive 10 face-to-face individual therapy sessions, once a week, which will last for 45 minutes. In addition, This group will also receive a self-help training through an application installed on their smartphone.
Main outcome variables
.Maladaptive perfectionism, psychological symptoms (depression, anxiety and stress), psychological well-being, life satisfaction, procrastination.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231018059762N1
Registration date: 2024-02-02, 1402/11/13
Registration timing: retrospective

Last update: 2024-02-02, 1402/11/13
Update count: 0
Registration date
2024-02-02, 1402/11/13
Registrant information
Name
Gelavizh Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6673 5426
Email address
mohammadi.g@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of cognitive-behavioral therapy with combined cognitive-behavioral therapy (face-to-face + web-based application) university students' maladaptive perfectionism
Public title
The effect of cognitive-behavioral therapy with combined cognitive-behavioral therapy and self-help (web-based application) on maladaptive perfectionism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having incompatible perfectionism. Being a student. The minimum age is 18 years and the maximum age is 35 years. Access to the Internet and smart mobile phones in the combined treatment group
Exclusion criteria:
Having symptoms of psychosis Autism spectrum disorder Having bipolar disorder and other related disorders Addictive and substance-related disorders Simultaneous participation in other psychotherapies
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
N/A
Randomization description
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
کمیته اخلاق دانشگاه علوم پزشکی ایران
Street address
Research and Technology Vice-Chancellor, Central Headquarters Building, Hemat Highway, next to Milad Tower
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-09-20, 1402/06/29
Ethics committee reference number
IR.IUMS.REC.1402.571

Health conditions studied

1

Description of health condition studied
maladaptive perfectionism
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Problems of maladaptive perfectionism
Timepoint
Before intervention, Immediately After Intervention, 3 Months after intervention
Method of measurement
Perfectionism Scale

Secondary outcomes

1

Description
Psychological symptoms ( Depression, Anxiety, Stress)
Timepoint
Before intervention, Immediately after intervention, 3 Months after intervention
Method of measurement
Depression Anxiety Stress Scale

2

Description
Psychological well-being
Timepoint
Before intervention, Immediately after intervention, 3 Months after intervention
Method of measurement
Psychological well-being scale

3

Description
Life satisfaction
Timepoint
Before intervention, Immediately after intervention, 3 Months after intervention
Method of measurement
Life satisfaction scale

4

Description
procrastination
Timepoint
Before intervention, Immediately after intervention, 3 Months after intervention
Method of measurement
Procrastination scale

5

Description
Adherence to therapy
Timepoint
Immediately after intervention, 3 Months after intervention
Method of measurement
Adherence to therapy Scale

Intervention groups

1

Description
Intervention group: Intervention group: Intervention group: cognitive-behavioral therapy group: a treatment protocol that includes the combination of Beck's cognitive therapy approach and Ellis' logical-emotional therapy will be used for the intervention. In this way, students with maladaptive perfectionism will receive 10 face-to-face individual treatment sessions once a week, which will last for 45 minutes.
Category
Behavior

2

Description
Intervention group:Description of intervention 2: groups of combined cognitive-behavioral therapy: (face-to-face + web-based application): For the intervention, a treatment protocol that includes the combination of Beck's cognitive therapy approach and Ellis' logical-emotional therapy will be used. Thus, students with maladaptive perfectionism will receive 10 face-to-face individual therapy sessions once a week, which will last for 45 minutes.Application: This self-help psychological training program was designed with the inspiration and use of the content of the perfectionism guide and is based on a cognitive-behavioral approach. This program is presented in the form of an application (based on the web) to the company. The multi-dimensional and audio-visual application is designed and adjusted in the form of videos, photos (diagrams) and written content in 10 sessions. In this intervention group, in addition to face-to-face therapy, the participants will use the training of application materials related to each session in the interval between face-to-face therapy sessions.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Armana Psychology and Counseling Service Center
Full name of responsible person
gelavizh Mohammadi
Street address
Unit 44, 4th flr., no. 12, Behesht-e 1 aly, Shariati st, above Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1458889694
Phone
+98 21 2284 2917
Email
armanapsy@gmail.com
Web page address
https://armanapsy.com/

2

Recruitment center
Name of recruitment center
Counseling Center of Sharif University of Technology
Full name of responsible person
gelavizh Mohammadi
Street address
Tehran, Azadi Street, Sharif University of Technology
City
Tehran
Province
Tehran
Postal code
1458889694
Phone
+98 21 6616 4051
Email
prm@sharif.edu

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences, 5th floor of the central headquarters
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
psy.mohammadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gelavizh Mohammadi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
psy.mohammadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gelavizh Mohammadi
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
psy.mohammadi@gmail.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
It is possible to misuse individual raw data.
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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Results from statistical analysis and reports of clinical outcomes will be available. Also, the informed consent form will be available for the Research Ethics Committee of Iran University of Medical Sciences
When the data will become available and for how long
The beginning of the period of access to the findings is one month after the publication of the data in the form of theses and articles.
To whom data/document is available
All researchers and health policy makers can access clinical findings and statistical analysis results. The informed consent form will only be available to the Research Ethics Committee of Iran University of Medical Sciences.
Under which criteria data/document could be used
The data will be available for stablishing meta-analyses, as well as for developing new protocols and presenting of reports at health-related conferences.
From where data/document is obtainable
Applicants can contact the following email addresses. Name of the respondent: Gulavizh Mohammadi. psy.mohammadi@gmail.com
What processes are involved for a request to access data/document
Answering the requests and sending the desired data will be done by email and will take about a month.
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