The comparing the efficacy of Specific Cognitive Behavioral Protocol and Unified Protocol in reducing student׳s anxiety sensitivity, anxiety, depression and negative affect: Double Blind Randomized Clinical Trial
comparing the efficacy of Specific Cognitive Behavioral Protocol and Unified Protocol in reducing student׳s anxiety sensitivity, anxiety, depression and negative affect.
Design
Thos double blind randomized clinical trial have two parallel intervention groups and a control group.
Settings and conduct
The study will be done at Zanjan University of Medical Sciences. Also In this study, participants and data analyzer will not be aware of the randomization process.
Participants/Inclusion and exclusion criteria
The participants must be students of Zanjan University of Medical Sciences, and also residence in Zanjan city and tending to participate in research.
Intervention groups
First group will receive specific cognitive behavioral therapy, second group will receive transdiagnostic therapy and third group will not receive any intervention.
Main outcome variables
Anxiety sensitivity, anxiety, depression and negative affect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180501039497N1
Registration date:2018-06-10, 1397/03/20
Registration timing:prospective
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Reza Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4001
Email address
ahmadi.reza@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparing the efficacy of Specific Cognitive Behavioral Protocol and Unified Protocol in reducing student׳s anxiety sensitivity, anxiety, depression and negative affect: Double Blind Randomized Clinical Trial
Public title
The comparing the efficacy of Specific Cognitive Behavioral Protocol and Unified Protocol in reducing anxiety sensitivity, anxiety, depression and negative affect
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being a student
Residence in the Zanjan city
Tending to participate in research
Exclusion criteria:
Drug abuse
Personality disorders
Cardiovascular diseases
More than two sessions of absenteeism during the intervention
Not attending in any of the evaluation sessions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block; Individual; Stratified; Random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
After sampling, any of participant will not aware from randomization and allocation to groups.
The data analyzer is selected outside of the study and all of datas will be given to him as a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.ZUMS.REC.1396.306
Health conditions studied
1
Description of health condition studied
Panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety] without agoraphobia
2
Description of health condition studied
Major depressive disorder
ICD-10 code
F33.0
ICD-10 code description
Major depressive disorder, recurrent, mild
3
Description of health condition studied
Emotional problems
ICD-10 code
R45
ICD-10 code description
Symptoms and signs involving emotional state
Primary outcomes
1
Description
Anxiety sensitivity
Timepoint
Pre-test, Post-test and follow up (two month after post-test)
Method of measurement
Anxiety Sensitivity Index- 3 (ASI-III)
Secondary outcomes
1
Description
Anxiety
Timepoint
Pre-test, Post-test and Follow up (Two month after post- test)
Method of measurement
Beck Anxiety Inventory (BAI)
2
Description
Depression
Timepoint
Pre-test, Post-test and Follow up (Two month after post-test)
Method of measurement
Beck Depression Inventory-II (BDI-II)
3
Description
Negative afect
Timepoint
Pre-test, Post-test and Follow up (Two month after post- test)
Method of measurement
Positive and Negative Affect Schedule-Negative (PANAS-NA)
Intervention groups
1
Description
First intervention group: Cognitive behavioral Therapy by Margo and Stewart's Protocol
Category
Behavior
2
Description
Second intervention group: Transdiagnostic of emotional disorders by Unified Protocol
Category
Behavior
3
Description
Control group: Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Omid Saed
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Phone
+98 24 3342 0670
Fax
+98 24 3354 2403
Email
ahmadi.reza@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=en&sid=1
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Soghrat Faghihzadeh
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3342 0651
Email
s.faghihzadeh@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Omid Saed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 2403
Email
o.saed@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Reza Ahmadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
Zanjan
Province
Zanjan
Postal code
۱۵۷۸۸-۴۵۱۳۶
Phone
+98 24 3354 2403
Email
ahmadi.reza@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Reza Ahmadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
Zanjan
Province
Zanjan
Postal code
15788-45136
Phone
+98 24 3354 2403
Email
ahmadi.reza@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of information related to main outcome will be published.
When the data will become available and for how long
Start the access period from 2019
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to documents is possible to inform other researchers.
Access to documents is possible to work with the researcher.
From where data/document is obtainable
DR. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Omid Saed, Mobile: 09128425270
Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Reza Ahmadi, Mobile: 09142828221
What processes are involved for a request to access data/document
Documents will be shared only when the reason for the request is announced by phone or e-mail.