Protocol summary

Study aim
Determining the effect of the program based on Logotherapy on the motives of committing suicide and tolerance of distress in patients attempting suicide
Design
This study is a clinical trial with a control group and it is performed on 70 samples. Randomization in this study is done using a table of random numbers
Settings and conduct
The research environment, is Khorshid and Farabi hospitals in Isfahan.The sample of our study will be composed of suicidal patients hospitalized in these centers.The sessions of the logotherapy program will be conducted in six 45-minute sessions and in the form of groups of eight to ten patients for the intervention group and three times a week, by the student and with the supervision and accompaniment of the supervisor in the department's classroom.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized with a diagnosis of suicide by a psychiatrist, at least 18 years old, the patient has not been admitted to the ward with a diagnosis of schizophrenia, schizoaffective, schizophrenic form, delusions and substance use disorder. Non-entry criteria: the patient has psychiatric disorders such as schizophrenia, schizoaffective, schizopherniform, substance use disorder. The patient's suffering from mental retardation or diagnosed cognitive problems such as dementia according to the documentation of the patient's file, which distorts the patient's learning.
Intervention groups
Intervention group: The sessions of the logotherapy program will be conducted in 6 sessions of 45 minutes for the intervention group and three times a week in the classroom of the department.Control group:They will not receive any training program and at the end, the content of the sessions will be provided to the members of the control group
Main outcome variables
Motivations for suicide attempts; Distress tolerance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180416039321N4
Registration date: 2023-05-23, 1402/03/02
Registration timing: registered_while_recruiting

Last update: 2023-05-23, 1402/03/02
Update count: 0
Registration date
2023-05-23, 1402/03/02
Registrant information
Name
sima ghezelbash
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7607
Email address
ghezelbash@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the Logotherapy based program on motivations for suicide attempts and distress tolerance in suicidal patients
Public title
Investigating the effect of the Logotherapy based program on motivations for suicide attempts and distress tolerance
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient should be interested and consent to participate in the study Being diagnosed with suicide by a psychiatrist and admitted to one of the departments of Khorshid or Farabi hospitals The patient must be at least 18 years old Have the ability to read, write and speak Persian
Exclusion criteria:
The patient has previously received interventions similar to this study The patient has psychiatric disorders such as schizophrenia, schizoaffective, schizophreniform, delirium and substance use disorder
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
70 patients who meet the conditions for entering the study will be selected, then they will be randomly assigned into two groups of 35 people, intervention and control. Random allocation of samples in two intervention and control groups is done using a table of random numbers. A table of random numbers is a collection of numbers that are generated completely randomly without a specific pattern or order and are made into a table.To use the table of random numbers, the researcher first determines the direction of reading the numbers in the table (for example, up, down, left or right). Also, numbers are considered for the studied groups (for example, even numbers are considered for the intervention group and odd numbers are considered for the control group). For this purpose, the researcher selects one of the digits of the random number table with his eyes closed, Then, by moving in one of the predetermined directions in the table of random numbers, chooses 35 even numbers and 35 odd numbers and writes them down on paper. All selected numbers are placed in a box. Each participant in the study takes a piece of paper from the box and depending on whether the number written on it is even or odd, they are placed in one of the two test or control groups.
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 Isfahan University of Medical Sciences
Street address
Iran, Isfahan, Hazar Jarib St., Isfahan University of Medical Sciences, Research Assistant
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.174

Health conditions studied

1

Description of health condition studied
Suicidal patients
ICD-10 code
T14.91
ICD-10 code description
Suicide attempt

Primary outcomes

1

Description
Motivations for suicide attempts in suicidal patients
Timepoint
At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention
Method of measurement
May and Klonsky Inventory of Motivations for Suicide Attempts

2

Description
Distress tolerance in suicidal patients
Timepoint
At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention
Method of measurement
Simons and Gaher Distress Tolerance Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Sessions of the meaning therapy program during 6 sessions of 45 minutes and 3 times in each week and in the form of groups of eight to ten patients by researcher for the intervention group in the classroom will be conducted. The educational content of the sessions will be prepared based on the existing texts and Viktor Frankl's semantic therapy theory and Hotzel plan. The titles of the sessions include familiarity with logo therapy and the need for meaning in life, belief and acceptance of oneself and recognition of one's own characteristics, attention to spiritual freedom as one of the dimensions of human existence, awareness of responsibility, recognition of stress and its factors and ways Reducing and dealing with it, recognizing existential anxiety, the importance of communicating with others and maintaining it, examining the meaning of suffering, overcoming despair and hopelessness, and recognizing values.
Category
Other

2

Description
Control group: It should be noted that no special intervention will be implemented for the control group. At the end of the program, in order to comply with ethics in research we will provide them with the content of the training sessions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Mahgol Nasr Esfahani
Street address
Farabi Specialized and Subspecialized Hospital, Arghwaniye Blvd., Mushtaq 3rd St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
81551-13153
Phone
+98 31 3795 2000
Fax
+98 31 3531 1460
Email
farabi@mui.ac.ir

2

Recruitment center
Name of recruitment center
Noor and Ali Asghar Hospital
Full name of responsible person
Mahgol Nasr Esfahani
Street address
Noor and Ali Asghar Hospital, Governorate Street, Esfahan
City
Esfahan
Province
Isfehan
Postal code
81458-33117
Phone
+98 31 3222 2127
Email
Nour@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Nursing and Midwifery Faculty., Isfahan University of Medical Sciences., Hezerjerib Ave
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Mahgol Nasr Esfahani
Position
Master's student in psychiatry
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7565
Email
mahgolnasrr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahgol Nasr Esfahani
Position
Master's student in psychiatry
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University Of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7565
Fax
Email
mahgolnasrr@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sima Ghezelbash
Position
Faculty member- instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University Of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7565
Fax
Email
ghezelbash@nm.mui.ac.ir

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
Not applicable
Data Dictionary
Not applicable
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