Protocol summary

Study aim
This research is conducted with the aim of comparing the effectiveness of adolescent-oriented mindfulness therapy and teaching emotion regulation strategies on high-risk behaviors, mind wandering, and adolescent depression.
Design
Randomised clinical trial has a control group, double-blind, on 45 depressed teenagers.
Settings and conduct
A semi-experimental research has been conducted on depressed teenage girls in Isfahan city in 1400. double-blind (experimental group and control group).
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 first experimental group underwent eight weekly sessions of adolescent-oriented mindfulness. The second experimental group underwent eight training sessions on emotion regulation strategies. and the control group that did not receive any intervention.
Main outcome variables
Effective exposure of adolescents to dysfunctional people, events and attitudes Enhancing non-judgmental attention to a specific event in the present

General information

Reason for update
Acronym
MBT
IRCT registration information
IRCT registration number: IRCT20230116057137N2
Registration date: 2023-04-26, 1402/02/06
Registration timing: registered_while_recruiting

Last update: 2023-04-26, 1402/02/06
Update count: 0
Registration date
2023-04-26, 1402/02/06
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
2023-04-09, 1402/01/20
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Adolescent-Centered Mindfulness Treatment and Emotion Regulation Strategies Training on High-Risk Behaviors, Mind Wandering and Symptoms of Depressed Adolescents
Public title
Effect of Adolescent-Centered Mindfulness Treatment and Emotion Regulation on High-Risk Behaviors, Mind Wandering and Symptoms of Depression.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age range 13-17 years 2. Being able to read and write 3. Not suffering from acute or chronic mental disorders during the past week (confirmed by a psychiatrist or clinical psychologist) 4. Not using simultaneous psychological treatments 5. Not taking psychiatric drugs for the past 3 months (by asking clients) 6. Not suffering from physical diseases (diagnosed by a doctor and acknowledged by the client)
Exclusion criteria:
Being over 18 years old Suffering from physical and movement diseases Being illiterate or illiterate Suffering from chronic psychological diseases People undergoing psychological treatment. People who are taking psychiatric medication.
Age
From 12 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: simple random draw Randomization Unit: Individual Randomization tool: Lottery The numbers 1-60 are randomly distributed among 60 subjects, then we put the numbers 1-60 in the box and the first 15 numbers out of the box are in the first test group and the second 15 numbers are in the second test group and the remaining people in the group are under control.
Blinding (investigator's opinion)
Single blinded
Blinding description
Double-blind means that the people in the sample group did not know whether they were in the experimental group or the control group. Therefore, explaining the objectives of the research only for the experimental group and ignorance of the selection in the two groups was the blinding method of the present study, considering that after the work was completed, the treatment was also applied to the control group.
Placebo
Not used
Assignment
Other
Other design features
A factorial trial with a design provides separate assessment of the effects of more than one treatment.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University
Street address
No. 8, Afshin Alley, Khaghani Street
City
Isfahan
Province
Isfehan
Postal code
8175857174
Approval date
2022-12-05, 1401/09/14
Ethics committee reference number
IR.UI.REC.1401.098

Health conditions studied

1

Description of health condition studied
High-Risk Behaviors, Mind Wandering, Depression
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
Investigating depression at the beginning of the study, 60 and 45 days after the intervention
Method of measurement
Beck depression questionnaire

Secondary outcomes

1

Description
Reducing High_Risk behaviors
Timepoint
At the beginning of the study and 60 and 45 days after the intervention
Method of measurement
Questionnaire of risky behaviors

2

Description
Reducing mind wandering
Timepoint
At the beginning of the study and 60 and 45 days after the intervention
Method of measurement
Wandering Mind Scale

Intervention groups

1

Description
Intervention group: First, the first experimental group underwent eight weekly sessions of 60 minutes of adolescent-oriented mindfulness using the manual for teaching mindfulness skills to children and adolescents by Burdick .
Category
Treatment - Other

2

Description
Intervention group: Second, the second experimental group underwent eight weekly sessions of 60 minutes of emotion regulation strategies training using the book Emotion Regulation Strategies by Grass.
Category
Treatment - Other

3

Description
Control group: They did 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
Janbazan street, Maher Alley
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
Masire Zendegi counseling center
Full name of responsible person
Hossein Rahimi
Street address
No. 84, Saadi Hospital Alley
City
Isfahan
Province
Isfehan
Postal code
8171857175
Phone
+98 31 3625 5636
Email
info@masir-zendegi.ir
Web page address
https://masir-zendegi.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
Janbazan Ave, Maher Alley
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?
No
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 higher education institute
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
]sfahan
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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