Determine the Effect of Positive Psychology on Depression in Patients with Depression
Design
In this study, 100 patients with major depressive disorder who are eligible to enter the study are selected. Participants are randomly assigned to two intervention and control groups, each assigned a code.
Settings and conduct
The venue for the training sessions will be the Neuroscience Classroom. Group-based teaching is accompanied by lectures and group discussions, and at the end of each session, the assignments will be reviewed.
Participants/Inclusion and exclusion criteria
Entry criterion (patients with major depressive disorder)
Exit criteria (presence of psychotic symptoms and reluctance to participate in the study)
Intervention groups
The intervention group (the intervention group participates in 8 sessions of therapeutic intervention, each session being 90 minutes long)
Control group (do not receive any intervention)
Main outcome variables
Change the Beck Depression Inventory Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180311039044N1
Registration date:2019-03-16, 1397/12/25
Registration timing:retrospective
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Sohaila Shaibanynejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 0116
Email address
khabar15172@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of positive psychotherapy on the symptoms of depression, hopelessness and suicide in patients with major depressive disorder
Public title
Positive Psychotherapy on Depression Symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Have reading and writing skills
Patients with major depressive disorder with psychiatrist diagnosis
Exclusion criteria:
Having other psychiatric disorders simultaneously
Substance Abuse
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Participants with initial entry criteria based on a computerized random number table will be allocated to intervention and control groups. In this way, from the first row, the number of pairs smaller than the total number of samples will be allocated to the intervention group and the individual numbers smaller than the whole sample will be assigned to the control 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 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
2018-08-01, 1397/05/10
Ethics committee reference number
IR.SUMS.REC.1397.148
Health conditions studied
1
Description of health condition studied
Major depressive disorder, recurrent severe without psychotic features
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
Primary outcomes
1
Description
Change in depression score
Timepoint
Before intervention - Immediately after intervention - Three month after intervention.
Method of measurement
Beck Depression Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention consists of 8 groups of positive psychotherapy sessions. Each session will be 90 minutes long, with the first 30 minutes being devoted to discussions on the principles of positive psychotherapy. 30 minutes to group discussion and exchange of comments and 30 minutes to review assignments.
Category
Behavior
2
Description
Control group: Participate in eight free sessions
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Psychiatry, Dr. Ali Shariati Hospital, Fasa
Full name of responsible person
Soheila Sheybani
Street address
Shariati Street, Dr. Ali Shariati Hospital
City
Fasa
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3575 4443
Email
khabar15172@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Deputy of Research of Shiraz University of Medical Sciences
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
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
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
Soheila Sheybani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz- Zand Avenue
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 7282
Email
khabar15172@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soheyla Sheybani
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
Email
khabae15172@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
SoheylaSheybani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz- Rudaki Avenue
City
Shiraz
Province
Fars
Postal code
32357282 71
Phone
+98 71 3234 5432
Email
khabar151373@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available