Protocol summary

Study aim
Determining the effectiveness of the Reintegration Process (TRP) treatment model on improving executive functions, increasing neurological flexibility, and modifying schemas associated with major depressive disorder and post-traumatic stress in veterans over 25% of psychiatric nerves.
Design
The present research is an applied quasi-experimental study as a pre-test-post-test with a control and follow-up group of 45 days. Regular or systematic random sampling of 20 people in each experimental and control groups will be selected from a total of 80 people from Sadr and Niayesh hospitals.
Settings and conduct
The experimental groups are trained for 12 sessions (reintegration process therapy model) in a group manner. 90-minute sessions once a week. The control group does not receive treatment protocols. Meetings will be held at Niayesh and Sadr Hospital
Participants/Inclusion and exclusion criteria
Veterans over 25% Have the signs and symptoms of major depressive disorder and PTSD - Agree to participate in the research and sign a written consent. No symptoms and psychotic disorders Lack of criteria for personality disorders No symptoms of substance abuse.
Intervention groups
veterans over 25% of psychiatric nerves.
Main outcome variables
Executive functions, - Neurological flexibility - Plans related to major depressive disorder - Post-traumatic stress - Veterans over 25% of psychiatric nerves

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220112053702N1
Registration date: 2023-10-05, 1402/07/13
Registration timing: retrospective

Last update: 2023-10-05, 1402/07/13
Update count: 0
Registration date
2023-10-05, 1402/07/13
Registrant information
Name
reza salmanipour noglebari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 2020
Email address
reza_salmanipoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
2022-01-05, 1400/10/15
Actual recruitment end date
2022-05-20, 1401/02/30
Trial completion date
2022-09-21, 1401/06/30
Scientific title
Evaluation of the effectiveness therapeutic reconsolidation process model (TRP) on executive functions, neuroplasticity and schemas associated with major depressive disorder and post-traumatic stress in veterans over 25% of psychiatric nerves
Public title
therapeutic reconsolidation process model (TRP)
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Veterans over 25% Having the signs and symptoms of major depressive disorder and PTSD - In case of drug use, the possibility of keeping constant the type and amount of drug used during the research
Exclusion criteria:
Having psychotic symptoms and disorders at the discretion of a clinical psychologist or psychiatrist. Having criteria for personality disorders at the discretion of a clinical psychologist or psychiatrist Having symptoms of substance abuse
Age
From 45 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
After compiling the list by regular or systematic random sampling method, using the Kerchsey and Morgan table, 20 people in each experimental and control group, a total of 80 people from Sadr and Niayesh hospitals will be selected.
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
Working Group / Research Ethics Committee of Islamic Azad University - Sanandaj Branch
Street address
7XXQ+33J, Sanandaj, Kurdistan Province
City
Sanandaj
Province
Kurdistan
Postal code
168
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.IAU.SDJ.REC.1400.021

2

Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش بنیاد شهید وامور ایثارگران
Street address
No. 17, Farrokh St., Ardabili moghdasSt
City
Tehran
Province
Tehran
Postal code
4720899511
Approval date
1962-07-03, 1341/04/12
Ethics committee reference number
IR.ISAAR.REC.1401.003

Health conditions studied

1

Description of health condition studied
Post-Traumatic Stress Disorder
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Major Depressive Disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effectiveness of treatment on major depressive disorder
Timepoint
For 12sessions for 3 months
Method of measurement
Beck Depression Inventory, Second Edition: (BDI 2)

2

Description
The effectiveness of treatment on Post traumatic Stress Disorder
Timepoint
For 12 sessions for 3 months
Method of measurement
(The Post Traumatic Stress Disorder CheckList / PCL

3

Description
Effectiveness of treatment on executive function and flexibility and schemas associated
Timepoint
For 12 sessions for 3months
Method of measurement
WCST /Stroop test/Leahy Emotional Schemas

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Other

2

Description
Control group:
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurological Psychiatric Hospital
Full name of responsible person
DR. Danashmand
Street address
No. 1, Golestan St., No. 1, Niayesh Psychiatric Hospital, Baghestan 1st St., Saadat Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1998634313
Phone
+98 21 2207 9738
Fax
+98 21 2207 9739
Email
reza_salmanipoor@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Veterans Engineering and Medical Sciences Research Institute
Full name of responsible person
Dr. Javad Minavi
Street address
No. 17, Farrokh St., Moqaddas Ardabili St., Yemen St., Jamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
4720899511
Phone
+98 21 2217 1010
Fax
+98 21 2241 8180
Email
jminooeefar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Veterans Engineering and Medical Sciences Research Institute
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Veterans Engineering and Medical Sciences Research Institute
Full name of responsible person
Reza salmanipour
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 17, Farrokh St., Moqaddas Ardabili St., Yemen St., Jamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
4720899511
Phone
+212 2172020
Email
reza_salmanipoor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Veterans Engineering and Medical Sciences Research Institute
Full name of responsible person
Reza salmanipour
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 17, Farrokh St., Moqaddas Ardabili St., Yemen St., Jamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
4720899511
Phone
009822172020
Email
reza_salmanipoor@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Institute
Full name of responsible person
reza salmanipour
Position
Expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 17, Farrokh St،Mogadas Ardabili ،StYemen St.Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
4720899511
Phone
009821222020
Email
REZA_SALMANIPOOR@YAHOO.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
Part of the data
When the data will become available and for how long
Six months after printing
To whom data/document is available
For academic researchers
Under which criteria data/document could be used
In PDF format
From where data/document is obtainable
Veterans Engineering and Medical Sciences Research Institute
What processes are involved for a request to access data/document
Administrative correspondence after 15 days
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