Protocol summary

Study aim
Determination of the Effectiveness of Online Psychological Intervention Using Skype on Depression and Anxiety and Quality of Life in Patients
Design
Clinical trials, blind
Settings and conduct
The statistical population consists of all people who contact with the semiarom Online Counseling System and have symptoms of anxiety and depression and The research sample will consist of 12 patients who meet the criteria for entering the research. Subjects are selected through contact with the online counseling system of the semiarom and after then selecting the necessary coordination. All participants of the demographic questionnaires, Beck Depression Index (BDI-II), Beck Anxiety Inventory (BAI), World Health Organization Quality of Life Questionnaire, Initially And complete the treatment at the end of the treatment and 3 months after the completion of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having a higher score than normal depression and anxiety in the anxiety and depression questionnaire Minimum education guidance Age range 18 to 60 And the willingness to attend the courses in the present study Exclusion criteria: Chronic physical illness, such as cancer, chronic glands, MS, and others. Severe psychiatric disorders such as psychosis, dementia and ... Based on SCID 1 Severe personality disorders such as schizotypal and paranoid, schizoid, and frontier based on SCID 11
Intervention groups
Experimental group: A 12-week program, with 45-minute sessions once a week by its contributors, and this cognitive behavioral intervention is done individually and through Skype.
Main outcome variables
Depression-Anxiety-Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141108019855N9
Registration date: 2019-08-02, 1398/05/11
Registration timing: retrospective

Last update: 2019-08-02, 1398/05/11
Update count: 0
Registration date
2019-08-02, 1398/05/11
Registrant information
Name
Samira Masumian
Name of organization / entity
Tehran Psychiatry Institue
Country
Iran (Islamic Republic of)
Phone
+98 21 3349 6990
Email address
samira.masumian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Internet-Based Psychological Intervention in patients with symptoms of depression and anxiety
Public title
The Effectiveness of Internet-Based Psychological Intervention in Reducing Depression and Anxiitey
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include having a higher score than normal depression and anxiety in the Beck anxiety and depression questionnaires, the absence of chronic physical conditions such as cancer, chronic doors, MS
Exclusion criteria:
Thoughts and suicide attempts
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 12
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
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1397.1095

Health conditions studied

1

Description of health condition studied
Anxiety and depression
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Depression
Timepoint
Before and after and 3 months later treatment
Method of measurement
Beck Depression Inventory

2

Description
Anxiety
Timepoint
Before and after and 3 months later treatment
Method of measurement
Beck Anxiety Inventory

3

Description
Quality of Life
Timepoint
Before and after and 3 months later treatment
Method of measurement
Quality of Life Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A 12-week program, with 45-minute sessions once a week, and this cognitive behavioral intervention is done individually and through Skype.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Behavioral Sciences and Mental Health
Full name of responsible person
Samira Masumian
Street address
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1515
Email
samira.masumian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Deputy of Research of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 86709
Email
ivco@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
School of Behavioral Sciences and Mental Health
Proportion provided by this source
70
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
Samira Masumian
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 6655 1515
Email
samira.masumian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
samira masumian
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1515
Email
samira.masumian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1515
Email
samira.masumian@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
In this study Not applicable
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Effectiveness of Online Intervention
When the data will become available and for how long
2019
To whom data/document is available
Therapists
Under which criteria data/document could be used
Therapy
From where data/document is obtainable
articles
What processes are involved for a request to access data/document
Iran University of Medical Sciences
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