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The efficiency of emotion regulation on Gross model on Illogical Believes on Patient at risk of suicide: Clinical trial with control group

Protocol summary

Study aim
Investigating the The efficiency of emotion regulation on Gross model on Illogical Believes on Patient at risk of suicide
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, was used on 30 patients. Each participant is given a unique code. People who have an even code are classified in the control group (15 people) and people who have an odd code in the test group (15 people). The tester has no role in dividing them.
Settings and conduct
The participants were 30 patients who had a high score on the suicidal ideation scale based on the screening done at Ibn Sina Hospital in Shiraz, and Gross and John's emotional regulation questionnaire, Beck's suicidal ideation scale, and Jones' 40-question irrational beliefs. , Beck's frustration scale and Beckham et al.'s cognitive triangulation, before the intervention, after the intervention and one month after the intervention, will be completed by both groups and will be analyzed with SPSS software. To check the efficiency of the Gross model in emotion regulation, group therapy sessions were designed for the experimental group. The control group receives education related to public health and has no knowledge of the intervention of the experimental group.
Participants/Inclusion and exclusion criteria
The main conditions for entering the study before randomization: 1) Have a high score on the suicide scale. 2) Have a stable mood؛ The main conditions of not entering the study before randomization: Patients who are not interested in participating in the plan.
Intervention groups
The experimental group is the group for whom group therapy sessions are conducted using the Gross model method. The control group is the group that receives education related to public health.
Main outcome variables
Emotion regulation, Gross model, Irrational beliefs, Suicide risk

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131130015589N4
Registration date: 2023-07-01, 1402/04/10
Registration timing: prospective

Last update: 2023-07-01, 1402/04/10
Update count: 0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Arash Mani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 3070
Email address
mania@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-04, 1402/04/13
Expected recruitment end date
2023-07-14, 1402/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficiency of emotion regulation on Gross model on Illogical Believes on Patient at risk of suicide: Clinical trial with control group
Public title
The efficiency of emotion regulation on Gross model on Illogical Believes on Patient at risk of suicide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have a high score on the suicide scale. Have a stable mood.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The current research will be conducted as a single-blind clinical trial, and the sample members will be 30 patients who, based on screening, had a high score on the suicidal ideation scale upon entering Ibn Sina Hospital in Shiraz. Each participant is given a unique code. People who have an even code are classified in the control group (15 people) and people who have an odd code are classified in the experimental group (15 people).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University, Shiraz Branch
Street address
Islamic Azad University Pardis, km 5 Sadra City road, Shiraz
City
Shiraz
Province
Fars
Postal code
71993
Approval date
2023-06-19, 1402/03/29
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1402.026

Health conditions studied

1

Description of health condition studied
Emotion regulation
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Gross model
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Illogical Believes
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Risk of suicide
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Up-regulation (proper regulation) or down-regulation of positive or negative emotions. Also emotional re-evaluation and emotional suppression of the studied subjects
Timepoint
Before the intervention, After the intervention and one month after the intervention
Method of measurement
Emotional Regulation Questionnaire (EPQ) Gross and John (2003)

2

Description
Irrational beliefs of the studied people such as: helplessness against change, expecting approval from others, avoiding problems and emotional irresponsibility.
Timepoint
Before the intervention, After the intervention and one month after the intervention
Method of measurement
Standard questionnaire of irrational beliefs Jones (1969) version 40 questions

3

Description
The severity of suicidal thoughts in the studied subjects
Timepoint
Before the intervention, After the intervention and one month after the intervention
Method of measurement
Beck Suicidal Ideation Scale (BSS)

4

Description
Measuring the intensity of negative attitude, pessimism and hopelessness towards the future
Timepoint
Before the intervention, After the intervention and one month after the intervention
Method of measurement
Beck Hopelessness Scale (BHS)

5

Description
Evaluation of three cognitive dimensions of attitude in the studied subjects based on attitude towards self, attitude towards the world, attitude towards the future
Timepoint
Before the intervention, After the intervention and one month after the intervention
Method of measurement
Beckham et al. Cognitive Triad Inventory (CTI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 15 of the patients who, based on the screening, had a high score on the scale of suicidal thoughts upon entering the Ibn Sina Hospital in Shiraz, and were assigned an individual code in the classification, are included in this group (the examiner has no role in their classification). First, an explanatory meeting is held for sample people. Then, for this group, eight group therapy sessions of Grass's emotion regulation model with specific topics will be provided for two hours and within a month. For each session, a task is determined that is close to the topic. The topics of the sessions include: 1) introduction, 2) selection of the situation, 3) selection of the situation, 4) modification of the situation, 5) expansion of attention, 6) cognitive evaluation, 7 ) response adjustment and 8) application evaluation.
Category
Other

2

Description
Control group: 15 patients who, based on the screening, had a high score on the suicidal ideation scale upon entering the Ibn Sina Hospital in Shiraz, and received an even code in the division, are included in this group (the examiner has no role in their division).This group receives education related to public health.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina Psychiatry Training Hospital, Shiraz
Full name of responsible person
Maryam Amiry
Street address
Next to Bostan 13 Aban, Hafez St.
City
Shiraz
Province
Fars
Postal code
7199896376
Phone
+98 917 301 4295
Fax
Email
mania@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Mani Kazeron
Street address
Hafez Medical Education Hospital, Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7199896376
Phone
+98 917 301 4295
Email
mania@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Shiraz branch
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
Islamic Azad University
Full name of responsible person
Arash Mani Kazeron
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Hafez Medical Education Hospital, Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7199896376
Phone
+98 71 3627 9319
Email
mania@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Mani Kazeron
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Hafez Educational Hospital, Shahid Chamran Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
7199896376
Phone
+98 71 3627 9319
Fax
+98 71 3627 9319
Email
mania@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Amiry
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Amiri House, third door from the right, NO. 5, Javamanardi Alley, NO. 7, Molana Street, Phase 1, Sadra New City, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
7199896376
Phone
+98 71 4260 0078
Email
DonyAmiry91@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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