Investigating the effectiveness of unified transdiagnostic treatment on emotional disturbance, emotion regulation, distress tolerance, and suicidal tendencies in patients with a history of suicide attempts.
Investigating the effectiveness of unified transdiagnostic treatment on emotional disturbance, emotion regulation, distress tolerance, and suicidal tendencies in patients with a history of suicide attempts.
Design
A clinical trial with a community-based control group, with parallel groups
Settings and conduct
A consent form, a package of measurement tools with brief explanations to introduce the research plan, how to use the data in line with ethical codes, before the intervention are provided to the participants in Tehran's neuropsychiatric hospitals.
Participants/Inclusion and exclusion criteria
log in:
• Having at least one diagnosis in the field of emotional disorders based on DSM-5 diagnostic criteria
• Patient's consent to participate in the research
Exit:
• Having any type of psychotic disorder
• History of substance abuse and addiction to any other specific substance that shows tolerance and withdrawal symptoms.
• Receiving any type of psychological treatment at the same time
• The patient's unwillingness to continue the treatment process.
• Use of medication with variable doses prescribed by a psychiatrist
Intervention groups
On the control group, only the usual interventions are performed in the treatment center. At the end of the intervention, the post-test will be performed on both experimental and control groups.
Main outcome variables
Emotional turmoil؛ Excitement regulation؛ Tolerate distress؛ Desire to commit suicide again
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230627058601N1
Registration date:2023-07-08, 1402/04/17
Registration timing:registered_while_recruiting
Last update:2023-07-08, 1402/04/17
Update count:0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
Afsaneh Amiri
Name of organization / entity
Semnan Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 6657 3924
Email address
afsaneamiri320@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-08, 1402/04/17
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
Investigating the effectiveness of unified transdiagnostic treatment on emotional disturbance, emotion regulation, distress tolerance, and suicidal tendencies in patients with a history of suicide attempts.
Public title
Investigating the effectiveness of unified transdiagnostic treatment on emotional disturbance, emotion regulation, distress tolerance, and suicidal tendencies in patients with a history of suicide attempts.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having attempted suicide at least once and wanting to commit suicide again
Having at least one diagnosis in the field of emotional disorders
The stability of the patient's medication dose according to the psychiatrist's order
Patient's consent to participate in the research
Exclusion criteria:
Having any type of psychotic disorder
Receiving any type of psychological treatment at the same time
A history of substance abuse and addiction to any other type of substance in which symptoms of tolerance and withdrawal appear
Use of drugs with variable doses prescribed by a psychiatrist
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
Randomization description
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
Unit 1, Block 4, Kashani Dead End, Salim Bayat Alley, western pastor St., Pasteur Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1318864791
Approval date
2023-07-02, 1402/04/11
Ethics committee reference number
IR.IAU.SEMNAN.REC.1402.005
Health conditions studied
1
Description of health condition studied
Suicidal tendencies again
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Emotional disturbance; Emotion regulation; Tolerance of distress; Suicidal tendencies again
Timepoint
Two months
Method of measurement
Questionnaires; DASS-21, Gratz and Roemer (DERS2004), Distress Tolerance Simmons and Gaher, Beck Suicidal Ideation Scale
Secondary outcomes
1
Description
Emotional disturbance, Emotion regulation, Distress tolerance, Suicidal tendencies again
Timepoint
Two months
Method of measurement
Questionnaires; DASS-21, Gratz and Roemer (DERS2004), Distress Tolerance Simmons and Gaher, Beck Suicidal Ideation Scale
Intervention groups
1
Description
Intervention group: In addition to the usual interventions in the treatment center, the experimental group is subjected to transdiagnostic treatment intervention.
Category
Treatment - Other
2
Description
Control group: The control group receives only the usual interventions in the treatment center.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Neuropsychiatric hospitals
Full name of responsible person
Asaneh Amiri
Street address
Unit 1, Block 4, Kashani Dead End, Salim Bayat Alley, western pastor St., Pasteur Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1318864791
Phone
+98 21 6657 3924
Email
AfsaneAmiri320@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afsaneh Amiri
Street address
Unit 1, Block 4, Kashani Dead End, Salim Bayat Alley, western pastor St., Pasteur Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1318864791
Phone
+98 21 6657 3924
Email
AfsaneAmiri320@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afsaneh Amiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Block 4, Kashani Dead End, Salim Bayat Alley, western pastor St., Pasteur Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1318864791
Phone
+98 21 6657 3924
Email
AfsaneAmiri320@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afsaneh Amiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Block 4, Kashani Dead End, Salim Bayat Alley, western pastor St., Pasteur Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1318864791
Phone
+98 21 6657 3924
Email
AfsaneAmiri320@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afsaneh Amiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Block 4, Kashani Dead End, Salim Bayat Alley, western pastor St., Pasteur Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1318864791
Phone
+98 21 6657 3924
Email
AfsaneAmiri320@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Having at least one diagnosis in the field of emotional disorders according to DSM-5
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
Dr. Izadi's supervisor
Under which criteria data/document could be used
In order to guide the research process
From where data/document is obtainable
Afsaneh Amiri
What processes are involved for a request to access data/document