Comparison of the effect of Cognitive behavioral therapy and Emotion-based therapy on reducing the reliance on self-injurious functions in adolescents with self-injurious behavior.
Design
The clinical trial has two treatment groups and a control group with parallel, unblinded, randomized groups on 45 patients and outcome assessment.
Settings and conduct
To carry out the research, it will be referred to the second secondary schools of Semnan city. The sample size in this research will include 45 people who will be randomly divided into three groups of 15 people. In the next stage, these 3 groups of 15 people will be randomly assigned as the Emotion-focused experimental group, the Cognitive-behavioral experimental group, and the control group. 11group (45-minute) intervention sessions (2 sessions per week) will be held for the emotional-focused testing group. Also, 15 group intervention sessions will be held for the Cognitive behavioral testing group. The research will be carried out at the Empathy Counseling Center of Azad University, Semnan.
Participants/Inclusion and exclusion criteria
Entry requirements: Teenagers between the ages of 14 and 18 who have harmed their body for 5 days or more in the past year.
Injuring the body without suicidal intent.
Conditions of non-entry: no other mental illness
No drug addiction
Intervention groups
The sample size in this research will include 45 people who will be randomly divided into three groups of 15 people and will also be randomly assigned. A group of 15 people from Emotion-focused intervention, a group of 15 people from Cognitive behavioral intervention and a group of 15 people will be considered as the control group.
Main outcome variables
Independent variable: cognitive behavioral therapy and emotional therapy
Dependent variable: self-injury and self-injury functions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220705055377N1
Registration date:2022-08-13, 1401/05/22
Registration timing:retrospective
Last update:2022-08-13, 1401/05/22
Update count:0
Registration date
2022-08-13, 1401/05/22
Registrant information
Name
kiana kheirkhah
Name of organization / entity
The azad university of semnan
Country
Iran (Islamic Republic of)
Phone
+98 21 3344 8679
Email address
k.kheirkhah74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-25, 1401/05/03
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Cognitive-behavioral therapy and Emotion-focused therapy on reducing self-injury function in adolescents
Public title
Comparison of the effect of Cognitive-behavioral therapy and Emotion-focused therapy on reducing self-injury function in adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents between the ages of 14 and 18 who have harmed their body in 5 days or more in the last year.
Injuring the body without suicidal intent.
This behavior has resulted in clinically significant distress in interpersonal and academic functioning and other important areas.
Exclusion criteria:
Not having any other mental illness other than non-suicidal self-harm.
Not taking medicine during the research period
No drug addiction
Absence of acute and chronic diseases or events such as parental divorce in the previous year
No death of loved ones in the last 6 months
Age
From 14 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomness is done by lottery method. In this method, a code or number is prepared for each member of the sample, then the numbers are written on pieces of paper. The pieces of paper are placed in a container and mixed well, then 15 people are selected for the first treatment, 15 people for the second treatment and 15 people for the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan Azad University
Street address
Islamic Azad University, University Town, Semnan, Iran
City
semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.IAU.SEMNAN.REC.1401.007
Health conditions studied
1
Description of health condition studied
Non-suicidal self-injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of people who have self-harmed at least 5 times in the past year.
Timepoint
Measuring self-injury at the beginning of the study and after receiving interventions at the end of the study
Method of measurement
Self-injury questionnaire of Sanson (SHI)
2
Description
The percentage of people who have self-harm functions
Timepoint
Measuring self-injury at the beginning of the study and after receiving interventions at the end of the study
Method of measurement
Klonsky and Glenn self-injury functions questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group1: Intervention group 1: The program of cognitive behavioral therapy of self-injury is presented based on a flexible system and model. The treatment techniques of this treatment are effective on teenagers and young people who self-injure. This treatment has 13 sessions of 45 minutes and 51 pages of worksheets are considered for assignments (Tyler et al., 2015). First session :Educating teenagers about what self-injury is (first component: What is self-injury?) and providing the necessary information regarding the functions of self-injury and the timeline of self-injury behaviors (second component: the function of self-injury)second session:Identifying specific treatment problems and goals (third component: problems and goals). Introducing cognitive behavioral therapy and explaining how this therapy can be useful for self-harm (fourth component: What is cognitive behavioral therapy and how can it help my self-harm). Empowering teenagers to identify and understand their feelings (the fifth component: recognizing feelings).third session:Adolescents come to understand how self-harm has dominated their lives (sixth component: relationships and strengths). We prepare the teenager to be motivated to change (seventh component: Are you ready to change?) .Second stage: treatment planThe second stage of treatment has two main parts. In the first part, the thoughts, feelings and behaviors of the patient are discussed, and in the second part, the focus of the treatment is on solutions.fourth Session:This meeting has two parts. First, a review of the emotional memories of the fifth component is done, then if the teenager is in a depressed mood, activity planning is done. If activity planning is not necessary because the teenager has engaged in healthy activities during the week or the lack of activity is not the cause of depression, then the ninth component, the help triangle, can be used.By examining the emotional memories, we deal with the adolescent's feelings and examine the intensity and frequency of the feeling and discuss it (Eighth Component). We identify and examine the relationship between lack of feeling of success and lack of activity, contempt and lack of pleasure. We want fun activities to be done by examining the lost feelings during the week (continuation of component 8).fifth meeting:Introducing the help triangle (ninth component). Introduction and identification of negative spontaneous thoughts like help (tenth component).The sixth session:To identify negative spontaneous thoughts, two-dimensional thinking (black and white) and cognitive petrification, we use challenging thoughts and finding evidence for and against thoughts (11th component).The seventh session:Identification of fundamental beliefs (the twelfth component).The eighth session:Through cognitive-behavioral formula, we make teenagers understand their behavioral patterns. We use the collection of past and present experiences, fundamental beliefs and current maintaining factors for this purpose (the 13th component).The ninth session:A decision is made about what coping strategy is suitable for the teenager (fourteenth component). Introducing the concept of problem solving (15th component).Tenth session:Three techniques that help to manage tension and positive interaction are discussed (components 16, 17, and 18: self-expression training, anger management, and self-care).The eleventh session:Training to deal with fear and situation (19th component).The second meeting:Teaching emotions control (riding waves), self-awareness and self-acceptance and self-soothing to teenagers (components 20, 21 and 22).Thirteenth session:Considering coping alternatives for self-harm and summarizing the coping strategies that have been discussed during the previous sessions (component 23).
Category
Treatment - Other
2
Description
Intervention group2: Intervention group 2: In this research, emotion-oriented therapy means the number of nine intervention sessions (Greenberg, 2015). Intervention group 2: In this research, emotion-oriented therapy means the number of nine intervention sessions (Greenberg, 2015). The first session: introducing and presenting the concepts of emotion-oriented therapy. Making the clients aware of their emotions according to the physical sensations and the conceptualization of the case done by the therapist. The second session: the client welcomes and accepts his emotional experience. If necessary, emotion regulation is done by the therapist. The third session: description of feelings in the form of words by the client and presentation of emotional notebook assignment. The fourth session: discovery of primary and secondary emotions by the client with the help of the therapist. The second stage of treatment: quitting. They can trust the feeling they have reached as a good source of information or not, whether this feeling is useful or not, finally whether it is necessary to change this feeling or not (Greenberg, 2015). Fifth session: Evaluation Regarding whether the primary emotion is a healthy or unhealthy response. The sixth session: Helping the client to identify the negative voice associated with unhealthy emotion. Access to alternative healthy emotional responses Session 9: Creating a new narrative to challenge destructive beliefs and opinions about self becoming
Category
Treatment - Other
3
Description
Control group: Control group: A group of 15 people will be considered as a control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Education of Semnan City
Full name of responsible person
Kiana Kheirkhah
Street address
Basij Blvd, Next to Basij Crossing, Semnan
City
Semnan
Province
Semnan
Postal code
1234567892
Phone
+98 23 3344 8679
Email
k.kheirkhah74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan Islamic Azad University
Full name of responsible person
Shahab moradi
Street address
Islamic Azad University, University Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Phone
+98 23 3365 4040
Email
shahabmoradi66@gmail.com
Web page address
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan Islamic Azad University
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
Semnan Azad University
Full name of responsible person
kiana kheirkhah
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan, Iran
City
semnan
Province
Semnan
Postal code
۰۲۳۳۳۶۵۴۰۳۶
Phone
۰۲۳-۳۳۶۵۴۰۴۰-۹
Email
k.kheirkhah74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan Islamic Azad University
Full name of responsible person
kiana kheikhah
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan, Iran
City
semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Phone
۰۲۳-۳۳۶۵۴۰۴۰-۹
Email
k.kheirkhah74@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan Islamic Azad University
Full name of responsible person
kiana kheirkhah
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
University town - Islamic Azad University, Semnan branch
City
semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Phone
۰۲۳-۳۳۶۵۴۰۴۰-۹
Email
k.kheirkhah74@gmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as information on the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the announcement of the results
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.