Protocol summary
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Study aim
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Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive-Behavioral Group Therapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students.
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Design
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This clinical trial has two intervention groups and one control group, double blind and randomized ones.
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Settings and conduct
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After a diagnostic interview by a psychiatrist, patients who are diagnosed with social anxiety disorder are assigned randomly into intervention1, intervention2 and control groups. Evaluation is also performed three months after the intervention. The place of interview and intervention is the Department of Psychiatry and Clinical Psychology of Zanjan University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Inclusion criteria :
1. Tendency to participate in research;
2. A score of between 21 and 40 (mild to moderate social anxiety) in the SPIN;
3. 18 years and older;
4. Residence in Zanjan during research;
5. Being a student.
Exclusion criteria:
1. At the same time receive psychological treatment;
2. Absence of more than two continuous sessions in therapeutic sessions;
3. Lack of participation in one of the three stages of evaluation;
4. History of psychosis, alcohol related disorders, bipolar disorder and personality disorders;
5.At the same time taking psychiatric medications.
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Intervention groups
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The first group will receive cognitive behavioral group therapy and the second group will receive metacognitive group therapy. The third group will not take any intervention on them.
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Main outcome variables
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Symptoms of social anxiety disorder; social phobia; social interaction; fear of negative evaluation; cognitive-attentional syndrome; negative meta-cognitive beliefs about risk and uncontrolledness; positive beliefs about worry; cognitive confidence; cognitive self-awareness; need for thought control
General information
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Reason for update
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Acronym
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CBT & MCT
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IRCT registration information
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IRCT registration number:
IRCT20190518043626N1
Registration date:
2019-05-23, 1398/03/02
Registration timing:
prospective
Last update:
2019-05-28, 1398/03/07
Update count:
1
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Registration date
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2019-05-23, 1398/03/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-06-01, 1398/03/11
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Expected recruitment end date
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2019-07-17, 1398/04/26
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive - Behavioral GroupTherapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students:Double Blind Randomized Clinical Trial.
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Public title
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Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive - Behavioral GroupTherapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Tendency to participate in research.
A score of between 21 and 40 (mild to moderate social anxiety) in SPIN.
Age of 18 years and older.
Residence in Zanjan city during research.
Being a student.
Exclusion criteria:
At the same time receive psychological treatment.
Absence of more than two continuous sessions in therapeutic sessions.
Lack of participation in one of the three stages of evaluation.
History of psychosis, alcohol related disorders, bipolar disorder and personality disorders.
At the same time taking psychiatric medications.
Score 15 to 25 in BDI-II.
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After diagnosis by a specialist, patients are assigned to treatment groups 1, 2, and control group, regardless of their specific characteristics, by software, so that all participants have the odds of being in groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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After selecting a sample, none of the sample individuals will know about the randomization process and allocation process to the groups. The data analyst is selected outside of the study, and all data will be encoded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-05-15, 1398/02/25
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Ethics committee reference number
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IR.ZUMS.REC.1398.036
Health conditions studied
1
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Description of health condition studied
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social anxiety disorder
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ICD-10 code
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F40.1
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ICD-10 code description
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Social phobias
Primary outcomes
1
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Description
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Symptoms of Social Anxiety Disorder.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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Conver social phobia Questionnaire(SPIN) and social interaction anxiety scale(SIAS).
2
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Description
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social phobia.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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Conver social phobia Questionnaire(SPIN).
3
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Description
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Social interaction.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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social interaction anxiety scale(SIAS).
4
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Description
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Fear of negative evaluation.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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Fear of negative evaluation of short form questionnaire(FNES-B).
5
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Description
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Cognitive-attentional syndrome.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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CAS-1.
6
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Description
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Negative metacognitive beliefs about risk and uncontrollability.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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MCQ-30.
7
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Description
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Positive metacognitive beliefs about worries.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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MCQ-30.
8
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Description
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Cognitive Confidence.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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MCQ-30.
9
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Description
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Cognitive self-awareness.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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MCQ-30.
10
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Description
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Need to control thought.
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Timepoint
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Pre-test, post-test and follow-up (three months after the post-test).
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Method of measurement
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MCQ-30.
Intervention groups
1
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Description
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Intervention group:Cognitive-behavioral group therapy Based on Hoffman model.
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Category
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Behavior
2
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Description
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Intervention group:Metacognitive group therapy.
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Category
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Behavior
3
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Description
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Control group:No intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All information about the original outcome will be published with the likes of it.
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When the data will become available and for how long
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Get started since 1400.
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To whom data/document is available
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Researchers working in academia.
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Under which criteria data/document could be used
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Access to the documentation is possible for other researchers.
Access to the documentation is possible with the researcher.
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From where data/document is obtainable
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Shaheed Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr. Saeedeh Zooszian. Tel: 09032180053 Zanjan Shahid Beheshti Hospital, Department of Clinical Psychology, Fatemeh Rezaei Khodadadi. Tel: 09130514827
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What processes are involved for a request to access data/document
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The required documentation will be shared only by mentioning the reason for the request by email or telephone.
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Comments
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