Determining the effect of the Logo therapy on depression and hope of female prisoners
Design
In this research, 90 inmate women with symptoms of depression and prison conditions, Association were chosen purposefully and were randomly divided into two groups of control and intervention. Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
The venue for training sessions is for women prisoners. Which will be held in groups.
Participants/Inclusion and exclusion criteria
Entry criterion (female prisoners with symptoms of depression and frustration)
Exit criteria (presence of psychotic symptoms and reluctance to participate in the study)
Intervention groups
The intervention group (the intervention group participates in 10 sessions of therapeutic intervention, each session being 90 minutes long)
Control group (do not receive any intervention)
Main outcome variables
Improve symptoms of depression; increase hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023279N12
Registration date:2018-02-27, 1396/12/08
Registration timing:retrospective
Last update:2018-02-27, 1396/12/08
Update count:0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Shahrzad Yektatalab
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
yektash@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Shiraz University of Medical Sciences.
Expected recruitment start date
2017-12-16, 1396/09/25
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
2017-12-16, 1396/09/25
Actual recruitment end date
2017-12-26, 1396/10/05
Trial completion date
empty
Scientific title
The effect of Logo therapy on the rate of depression and hope for prisoner women
Public title
Effect of Logo therapy on depression and hope
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write
Age range 18 to 60 years
Having symptoms of depression
Exclusion criteria:
Learning and cognitive problems
Psychiatric Disorders
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
A two-digit code is allocated to each participant who has the criteria for entering the study. The codes are entered into the system of numbered finishes. Then the first row or the first column of sampling will begin. Among the two-digit codes that are smaller than the highest number of participants, 90 will be selected. Then again, 90 randomly selected individuals will be randomly assigned to the intervention and control groups using the random numbers table. Thus, the pair numbers in the intervention group and the individual numbers in the control group will be placed
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 Shiraz University of Medical Sciences
Street address
Imam Hossein Square., Zand Avenue., Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2017-12-06, 1396/09/15
Ethics committee reference number
IR.SUMS.REC.1396.141
Health conditions studied
1
Description of health condition studied
Moderate Depressive
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
2
Description of health condition studied
Major depressive disorder, recurrent severe without psychotic features
ICD-10 code
F33.2
ICD-10 code description
Major depressive disorder, recurrent severe without psychotic features
3
Description of health condition studied
Other recurrent depressive
ICD-10 code
F33.8
ICD-10 code description
Other recurrent depressive disorders
Primary outcomes
1
Description
Improve depression
Timepoint
Before intervention - Immediately after intervention - One month after intervention.
Method of measurement
Beck Depression Scale
2
Description
Increase hope
Timepoint
Before intervention - Immediately after intervention - One month after intervention
Method of measurement
Hope Miller's Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (intervention consists of 10 sessions of semantic intervention in group therapy. Each session will be 90 minutes long, and the first 30 minutes will be devoted to the discussion of the basic principles of therapeutic meaning. 30 minutes
Category
Behavior
2
Description
Control group (control group will not receive any intervention during the study period)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Adel Abad Prison
Full name of responsible person
Zakiye Ghelbash
Street address
No.5 , Ave., Boulevard of Edalat., Adel Abad Prison
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 2458 9127
Email
farsprisons@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Central Building Of Shiraz University Of Medical Sciences., Zand St.
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Fax
+98 71 3233 6858
Email
poshtoff@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Shiraz 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
Shiraz University Of Medical Sciences
Full name of responsible person
Zakiye Ghelbash
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz- Rudaki Avenue
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 7282
Fax
+98 71 3233 6858
Email
z.ghelbashp@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Shahrzad Yektatalab
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz-Namazai Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 7282
Fax
Email
shahrzadyekta@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zakiye Ghelbasg
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Street address
Shiraz-Namazai Square
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
00
Fax
Email
z.ghelbashp@yahoo.com
Web page address
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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
In this study only general data including depression score and hope are published. The data in the thesis are accessible through the Shiraz Nursing Faculty
When the data will become available and for how long
After the registration and publication of the dissertation
To whom data/document is available
Institutes and scientific and research organizations
Under which criteria data/document could be used
By obtaining permission from the researcher by sending an email
From where data/document is obtainable
School of Nursing and Midwifery of Shiraz
What processes are involved for a request to access data/document