Investigating the effect of spiritual intelligence with heart intelligence training on the psychological well-being of people who attempted suicide
Investigating the effect of spiritual intelligence with heart intelligence training in preventing suicide re-attempts after intervention
Design
Controlled single center clinical trial, with parallel groups, not blinded, randomized, phase I on 60 patients with a history of suicide attempt. A random number table will be used for randomization
Settings and conduct
This study will be performed in Loghman Hakim Educational and Medical Center. The control group will undergo routine psychiatric consultation and the intervention group will undergo routine psychiatric consultation plus online training course for spiritual intelligence based on heart intelligence for two month (three times a week). Patients mental health status will be examined by standard questionnaire (before and after the intervention) and the results of control and intervention groups will be compared. Furthermore, suicide re-attempt will be evaluated in two groups during six month follow-up.
Participants/Inclusion and exclusion criteria
The inclusion criteria include committing suicide and the patient's consent to participate in the study, and the exclusion criteria include not participating in three consecutive training sessions and unwillingness to continue participating in the study.
Intervention groups
Control group: Patients in this group will only undergo routine psychiatric consultation at the hospital before discharge.
Intervention group: In addition to receiving routine psychiatric counseling in the hospital, the patients of this group will also be trained in spiritual intelligence based on heart intelligence.
Main outcome variables
Mental health status of patients and suicide re-attempt during six month follow-up
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230221057474N1
Registration date:2023-02-23, 1401/12/04
Registration timing:prospective
Last update:2023-02-23, 1401/12/04
Update count:0
Registration date
2023-02-23, 1401/12/04
Registrant information
Name
Haleh Talaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 8175
Email address
dr.talaie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual intelligence based on heart intelligence training on the well-being of people who attempted suicide.
Public title
The effect of spiritual intelligence in preventing suicide attempt
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A history of suicide attempts
The patient's consent to participate in the study
Exclusion criteria:
Failure to participate in three consecutive training sessions
Unwillingness to continue participating in the study
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A table of random numbers will be used. Random number tables are generated by computers that randomly set the numbers. First, a two-digit code (according to the number of volunteers, which is 60) is given to each candidate , and after creating the table, a random selection of numbers is made. To select sample people from the table, randomly start from a point in the table moving in the direction of the row or column. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. Moving in the direction of the row or column does not make any difference and this is optional. After this, the path numbers are controlled, which will be dealt with two types of numbers, one of which is smaller than the volume of the population of the study and the other is larger than the number of the population. Only smaller numbers should be considered and selected. The selected number is actually the individual code that is selected as the sample. This should be continued until enough small number can be selected based on the number of volunteers. The first 30 numbers are patients who assigned to the control group and the second 30 numbers are patients who assigned to the intervention 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 Shahid Beheshti University of Medical Science
Street address
7th Floor, Building Number 2, Shahid Beheshti University of Medical Science , Arabi Avenue, Daneshjoo Boulevard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2023-02-20, 1401/12/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.756
Health conditions studied
1
Description of health condition studied
Suicide
ICD-10 code
T14.91
ICD-10 code description
Suicide attempt
Primary outcomes
1
Description
The mental health status of patients before and after the intervention according to the standard questionnaires
Timepoint
The mental health status of the patients will be checked at the beginning of the study and after the completion of the training course (two-month period).
Method of measurement
Ryff scales of psychological well-being, King’s Spiritual Intelligence Scale (SISRI), Beck Scale for Suicidal Ideation (BSSI)
2
Description
Suicide re-attempts during the 6-month period of follow-up
Timepoint
Re-attempting suicide will be investigated during the six-month follow-up period after the completion of the training course.
Method of measurement
Observation and contact with patients and family member
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to receiving routine psychiatric counseling in the hospital, the patients of this group will also be trained in spiritual intelligence based on heart intelligence.
Category
Other
2
Description
Control group: Patients in this group will only undergo routine psychiatric consultation at the hospital before discharge.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Haleh Talaie
Street address
Toxicological Research Center, Loghman Hakim Hospital, Kamali Ave, South Kargar St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
13336311510
Phone
+98 21 5541 8175
Email
dr.talaie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Toxicological Research Center
Full name of responsible person
Haleh Talaie
Street address
Toxicological Research Center, Loghman Hakim Hospital, Kamali Avenue, South Kargar Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 8175
Fax
+98 21 5540 8847
Email
dr.talaie@gmail.com
Web page address
https://trc.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Toxicological Research Center
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Haleh Talaie
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Toxicological Research Center, Loghman Hakim Hospital, Kamali Avenue, South Karegar Street
City
Tehran
Province
Tehran
Postal code
13336311510
Phone
+98 21 5541 8175
Fax
Email
dr.talaie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Haleh Talaie
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Toxicological Research Center, Loghman Hakim Hospital, Kamali Avenue, South Karegar Street
City
Tehran
Province
Tehran
Postal code
13336311510
Phone
+98 21 5541 8175
Fax
Email
dr.talaie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Haleh Talaie
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Toxicological Research Center, Loghman Hakim Hospital, Kamali Avenue, South Karegar Street
City
Tehran
Province
Tehran
Postal code
13336311510
Phone
+98 21 5541 8175
Fax
Email
dr.talaie@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of the data, such as the information related to the main result can be shared.
When the data will become available and for how long
The access period starts after the publication of the last results
To whom data/document is available
University researchers
Under which criteria data/document could be used
The only criterion will be citing the name of principal investigators in resultant academic works
From where data/document is obtainable
By contacting principal investigators via this email: dr.talaie@gmail.com
What processes are involved for a request to access data/document
Sending the email by the requester including their academic position or business information