Protocol summary

Study aim
The present study aims to investigate the effectiveness of emotion regulation training in reducing high-risk behaviors of depressed adolescents.
Design
Clinical trial with control group, single-blind, randomized, on 30 depressed teenagers. A lottery is used for randomization.
Settings and conduct
A semi-experimental research conduct on depressed teenage girls in Isfahan city in 1401. single-blind
Participants/Inclusion and exclusion criteria
Entry requirements: 1. Age range of 13-17 years, 2. Having literacy, 3. Not suffering from acute or chronic mental disorders in the past week (confirmed by a psychiatrist or clinical psychologist), 4. Not using From concurrent psychological treatments, 5. not taking psychiatric drugs for the past 3 months (by asking the clients) and 6. not suffering from physical diseases (diagnosed by a doctor and acknowledged by the client) that prevent them from participating in the plan be research Non-entry conditions: 1. Unwillingness to continue research; 2. Failure to do the assignments given in the sessions and 3. Absence of more than 2 sessions during the treatment.
Intervention groups
The experimental group undergoes eight training sessions on emotion regulation strategies. and the control group that does not receive any intervention.
Main outcome variables
Improving high-risk behaviors including drug addiction and abuse, high-risk sexual behaviors, smoking, violence, alcohol consumption, and unhealthy eating patterns

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230116057137N1
Registration date: 2023-04-03, 1402/01/14
Registration timing: registered_while_recruiting

Last update: 2023-04-03, 1402/01/14
Update count: 0
Registration date
2023-04-03, 1402/01/14
Registrant information
Name
Nooshin Salahi Esfahani
Name of organization / entity
Safahan Institute of Higher Education
Country
Iran (Islamic Republic of)
Phone
+98 31 3628 3309
Email address
r.izady@safahan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-16, 1401/12/25
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of emotion regulation training on reducing high-risk behaviors in depression adolescents
Public title
Effect of emotion regulation training in depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 13-17 years Being able to read and write Not suffering from acute or chronic mental disorders during the past week (confirmed by a psychiatrist or clinical psychologist) Not using simultaneous psychological treatments Not taking psychiatric drugs for the past 3 months (by asking clients) Not suffering from physical diseases (diagnosed by a doctor and acknowledged by the client)
Exclusion criteria:
Unwillingness to continue the research Failure to complete the assignments presented in the meetings Absence of more than 2 sessions during treatment
Age
From 13 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 65
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: simple random draw Randomization Unit: Individual Randomization tool: Lottery
Blinding (investigator's opinion)
Single blinded
Blinding description
Single-blind: In a single-blind study, only the participants are unaware of the study group assignment.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University
Street address
Isfahan University, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Approval date
2022-11-30, 1401/09/09
Ethics committee reference number
IR.UI.REC.1401.098

Health conditions studied

1

Description of health condition studied
High-Risk Behaviors
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
People who, in addition to having files in counseling centers with a diagnosis of depression, scored more than 20 in Beck's depression questionnaire.
Timepoint
Examination of depression at the beginning of the study, immediately after the training sessions and two months later
Method of measurement
Beck depression questionnaire

Secondary outcomes

1

Description
Reducing High_Risk behaviors
Timepoint
At the beginning of the study, immediately after the training sessions and two months after that
Method of measurement
Questionnaire of risky behaviors

Intervention groups

1

Description
Intervention group: The experimental group is subjected to eight weekly sessions of 60 minutes of emotion regulation strategies training using Grass's Emotion Regulation Strategies book.
Category
Treatment - Other

2

Description
Control group: They dont not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Safahan Counseling Center
Full name of responsible person
Raziyeh Izadi
Street address
Maher Alley, Janbazan street
City
Isfahan
Province
Isfehan
Postal code
8174743431
Phone
+98 31 3777 6556
Email
r.izady@safahan.ac.ir
Web page address
https://safahanpsy.ir

2

Recruitment center
Name of recruitment center
Pardis counseling center
Full name of responsible person
Hamed Jafari
Street address
Bozor Mehr Building, Bozor Mehr Street
City
Isfahan
Province
Isfehan
Postal code
8171857175
Phone
+98 31 3268 7064
Email
info@pardis.ir
Web page address
https://padideyehemayat.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Safahan Institute of Higher Education
Full name of responsible person
Dr. Mohammad Javad Liaqtdar
Street address
Maher Alley, Janbazan Ave
City
Isfahan
Province
Isfehan
Postal code
8174743431
Phone
+98 31 7777 6556
Email
edu@safahan.ac.ir
Web page address
https://safahan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Safahan Institute of Higher Education
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
Safahan Institute of Higher Education
Full name of responsible person
Nooshin Salahi Esfahani
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8, Afshin Alley, Khaghani Street
City
Esfahan
Province
Isfehan
Postal code
8175857174
Phone
+98 31 3628 3309
Email
nse1375@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Safahan Institute of Higher Education
Full name of responsible person
Nooshin Salahi Esfahani
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8, Afshin Alley, Khaghani Street
City
Isfahan
Province
Isfehan
Postal code
8175857174
Phone
+98 31 3628 3309
Email
nse1375@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Safahan Institute of Higher Education
Full name of responsible person
Nooshin Salahi
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8, Afshin Alley, Khaghani Street
City
Isfahan
Province
Isfehan
Postal code
8175857174
Phone
+98 31 3628 3309
Email
nse1375@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
There is no further information.
Study Protocol
No - There is not 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
No - There is not 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
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