Protocol summary

Summary
This is a quasi experimental study with pre-post test and control group design. Study population is women supported by Petroleum Industry Health Organization (PIHO) in Mohajeran city in Arak. They are invited to participate in the study via an announcement. Inclusion criteria are willingness to participate and accessibility to Telegram. Exclusion criterion is refusing to continue participation. Then, participants are allocated to study groups including short message, Telegram and control via systematic randomization. Instruments are DASS_21 Questionnaire and the Crandell Cognition Inventory (CCI) which are going to be filled before and immediately after the intervention and also two months later to assess long term learning. Validity and reliability of DASS_21 has been proofed before. We are going to assess the validity and reliability of CCI. After obtaining the subjects’ consent forms and completing the pretest, we would give all participants a compact disk (CD) containing a multimedia e-content about reducing negative thoughts. Then short message group would receive weekly messages for five weeks. Telegram group would participate in a discussion once a week for five weeks. There would be no follow up for control group. Finally, we compare the effect of short message, social network and not following up on women's negative thinking and mental health.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091223982N1
Registration date: 2015-12-03, 1394/09/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-03, 1394/09/12
Registrant information
Name
Rita Mojtahedzadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8088
Email address
r_mojtahedzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Tehran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of using social network, sending short messages and not using these tools on negative thinking status regarding women’s mental health
Public title
The impact of social network and Short message on negative thinking status in women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; Telegram accessibility Exclusion criterion: refusing to continue participation
Age
From 18 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants are allocated to the groups using random number table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Qods St, Keshavarz BLVD, Tehran
City
Tehran
Postal code
Approval date
2015-09-08, 1394/06/17
Ethics committee reference number
IR.Tums.REC.1394.732

Health conditions studied

1

Description of health condition studied
Negative Thinking
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder

Primary outcomes

1

Description
Negative Thinking
Timepoint
Pre intervention, post intervention and two months after intervention
Method of measurement
Crandell Cognitions Inventory

Secondary outcomes

1

Description
Anxiety, depression and stress
Timepoint
Pre intervention, post intervention and two months after intervention
Method of measurement
DASS-21 questionnaire

Intervention groups

1

Description
Not sending short messages or using social network
Category
Other

2

Description
Group discussion in Telegram social network
Category
Other

3

Description
Sending follow up short messages
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh Clinic
Full name of responsible person
Parvin Razmgah (Nurse)
Street address
gholha Square, Mohajeran, Arak
City
Mohajeran

2

Recruitment center
Name of recruitment center
Hazrat Valiasr Clinic
Full name of responsible person
Parvin Razmgah (Nurse)
Street address
Refinery Area, Mohajeran, Arak
City
Mohajeran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Yunesian
Street address
Qods St, Keshavarz BLVD
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hazrat Fatemeh Clinic
Full name of responsible person
Parvin Razmgah
Position
Nurse
Other areas of specialty/work
Street address
Golha Sq., Mohajeran, Arak
City
Mohajeran
Postal code
Phone
+98 86 3862 4189
Fax
Email
p_razmgah@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Virtual School of Tehran University of Medical Sciences
Full name of responsible person
Rita Mojtahedzadeh
Position
MD, PhD
Other areas of specialty/work
Street address
Dolatshahi Alley, Naderi St., Keshavarz BLVD
City
Tehran
Postal code
Phone
+98 21 8897 8088
Fax
Email
r_mojtahedzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Virtual School of Tehran Univercity of Medical Sciences
Full name of responsible person
Rita Mojtahedzadeh
Position
MD, PhD
Other areas of specialty/work
Street address
Dolatshahi Alley, Naderi St., Keshavarz BLVD
City
Tehran
Postal code
Phone
+98 21 8897 8088
Fax
Email
r_mojtahedzadeh@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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