Evaluating the effect of emotion regulation training on emotional and cognitive status of adolescent girls attempting suicide referred to Ebne sina hospital in 2017-2018.
Determination the effect of emotion regulation training on emotional and cognitive status of adolescent girls attempting suicide referred to Ebn sina hospital in 2017-2018.
Design
At first, in order to prevent the exchange of information between the groups, the number of samples required for both control and intervention groups will be sampled respectively by convenient sampling method. .
Settings and conduct
Intervention and sampling from patients admitted to Ebn sina Psychiatric hospital will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Teenage girls aged 13 to 18 years, Suicide attempt history, willingness to participate in research.
Exclusion criteria: People attending psychotherapy sessions simultaneously, bipolar patients, having symptoms of psychosis.
Intervention groups
The intervention group will receive 8 sessions of emotion regulation training (twice a week). And the control group will not receive intervention. And questionnaires will be filled by groups at the beginning of the study and one month later.
Main outcome variables
Emotional and cognitive status, depression, anxiety, stress, impulsivity, suicidal thought.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180516039680N1
Registration date:2018-07-27, 1397/05/05
Registration timing:registered_while_recruiting
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Seyedyounes Hosseini sarani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3840 6737
Email address
hoseini_y@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
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
Evaluating the effect of emotion regulation training on emotional and cognitive status of adolescent girls attempting suicide referred to Ebne sina hospital in 2017-2018.
Public title
Evaluating the effect of emotion regulation training on emotional and cognitive status of adolescent girls attempting suicide.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Teenage girls aged 13 to 18 years
Suicide attempt history
Willingness to participate in research
Exclusion criteria:
People attending other psychotherapy sessions simultaneously
Bipolar patients
Having symptoms of psychosis
Age
From 13 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Data will be analyzed without expressing the type of group to the analyst.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences.
Street address
Central building of Shiraz University of Medical Sciences, Zand street.
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.SUMS.REC.1396.148
Health conditions studied
1
Description of health condition studied
Cognitive and emotional status
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Depression
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Stress
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Impulsivity
ICD-10 code
ICD-10 code description
6
Description of health condition studied
Suicidal thought.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cognitive emotion regulation. The cognitive emotion regulation evaluates 9 strategy of self-denial, admission, rumination, positive re-focus, re-focus on planning, positive reappraisal, perceptiveness, disaster, and other people's health.
Timepoint
At the beginning of the study and 1 month after the study
Method of measurement
Cognitive emotion regulation questionnaire (CERQ)
2
Description
Depression. The substage of depression, includes the expressions of unhappy mood, lack of self-esteem, despair, worthlessness of life, lack of interest in conflict, lack of enjoyment of life, and lack of energy and power.
Timepoint
At the beginning of the study and 1 month after the study
Method of measurement
Depression anxiety and stress scale 21 qestionnaire
3
Description
Anxiety. Anxiety subscale has phrases that attempt to assess physiological arousal, fears, and situational anxiety.
Timepoint
At the beginning of the study and 1 month after the study
Method of measurement
Depression anxiety and stress Scale 21 questionnaire
4
Description
Stress. Stress subscale includes phrases such as difficulty in achieving relaxation, nervous tension, irritability and restlessness.
Timepoint
At the beginning of the study and 1 month after the study
Method of measurement
Depression anxiety and stress scale 21 questionnaire
5
Description
Impulsivity. Measures three components of non-planning, motion impulse, and cognitive impulse.
Timepoint
At the beginning of the study and 1 month after the study
Method of measurement
Barratt Impulsiveness Scale, eleventh edition.
6
Description
Suicidal thoughts. Detecting and measuring the severity of attitudes and planning to commit suicide
Timepoint
At the beginning of the study and 1 month after the study
Method of measurement
Beck suicide scal idetion questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: The intervention group will receive 8 sessions of emotion regulation training (twice a week). And questionnaires will be filled by the group at the beginning of the study and one month later.
Category
Treatment - Other
2
Description
Control group:The control group will not receive interventionand and the questionnaires will be filled by the group at the beginning of the study and one month later. And In order to comply with ethical principles, the control group will be given education after the end of the study or instruction booklet.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne sina hospital
Full name of responsible person
Ebrahim Moghimi
Street address
St Hafez, Near Bostan 13th Aban, Ebne sina hospital
City
Shiraz
Province
Fars
Postal code
7146676549
Phone
+98 71 3228 9601
Fax
+98 71 3228 6784
Email
ebnesina@sums.ac.ir
Web page address
http://ebnesina.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sayed Basir Hashemi
Street address
Central building of Shiraz university of medical sciences, Zand street
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Seyedyounes Hosseini sarani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychiatric Nursing
Street address
Floor 2, st10th golmorvarid Next to the left side,Baharstan Town.
City
Shiraz
Province
Fars
Postal code
7169654654
Phone
+98 71 3840 6737
Fax
Email
younes_smile@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedyounes Hosseini Sarani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychiatric Nursing
Street address
Floor 2, st10th golmorvarid Next to the left side,Baharstan Town
City
shiraz
Province
Fars
Postal code
7169654654
Phone
+98 71 3840 6737
Email
hoseini_y@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedyounes Hosseini Sarani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychiatric Nursing
Street address
Floor 2, st10th golmorvarid Next to the left side,Baharstan Town, Shiraz City, Fars Province, IRAN.
City
shiraz
Province
Fars
Postal code
7169654654
Phone
+98 71 3840 6737
Email
hoseini_y@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
The results of data on interventions will be accessible by maintaining ethical principles.
When the data will become available and for how long
After the end of the study, the results of the documentation will be available.
To whom data/document is available
The results of the project will be accessible to educational and research centers.
Under which criteria data/document could be used
Use and expand educational programs for teens to improve the quality of life and improve the mental status of individuals.
From where data/document is obtainable
Shiraz university of medical sciences.
What processes are involved for a request to access data/document
Referring to Shiraz University of Medical Sciences.