The Effectiveness of Short-Term Dynamic Psychotherapy in the Treatment of Major Depressive Disorders in both sexes
Design
Clinical trial with control group, the research population including male and female students referring to counseling clinic at Hamedan University of Medical Sciences, Samples are selected using diagnostic interview then, they are randomly assigned into two experimental and control groups.
Settings and conduct
Research is interventional type; in counseling clinic at Hamedan university of Medical Sciences; the interviewer is not aware of the purpose of the interview; the data analyzer is not aware of the purpose of the research.
Participants/Inclusion and exclusion criteria
exclusion criteria: having psychotic, obsessive-compulsive, bipolar disorder, organic brain disorders, drug and alcohol dependence, cluster A and B personality disorders
Intervention groups
The therapy sessions are conducted using McCullough's manual. This model utilizes an empathic and collaborative relationship with restructure defenses and anxieties that block feelings relating with self and others. This model retains many fundamental components of prior dynamic psychotherapies. McCullough's manual for short-term dynamic psychotherapy includes three main parts; defense restructuring, affect restructuring and self and other restructuring.
The control group will not receive any treatment then, after the completion of the research, they will be treated.
Main outcome variables
Sings of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160919029874N2
Registration date:2018-10-20, 1397/07/28
Registration timing:retrospective
Last update:2018-10-20, 1397/07/28
Update count:0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Mohammad Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0160
Email address
zarei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of short-term dynamic psychotherapy in treatment of major depressive disorder in students
Public title
Effectiveness of dynamic psychotherapy in treatment of major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Major depressive disorder
Age above 20 years
No history of psychotherapy
Exclusion criteria:
Having personality disorder
A score of less than 40 in the Beck Depression Inventory
Age
From 20 years old to 31 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization; Use the draw method; After the diagnostic interview, the names of the people who have the inclusion criteria are written, then each name is assigned a code. The codes are written on pieces of paper and then the patients are divided into experimental and control groups using lottery.
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 Hamedan University of Medical Sciences
Street address
Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838737
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.UMSHA.REC.1397.140
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32.3
ICD-10 code description
Major depressive disorder, single episode, severe with psychotic features
Primary outcomes
1
Description
Depression score in Beck Depression Inventory
Timepoint
Beginning of research, end of research, two times follow up for a month an two month
Method of measurement
Beck Depression Inventory
2
Description
Defense Styles
Timepoint
Beginning of research, end of research, two times follow up for a month an two month
Method of measurement
Defense Styles Quastionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive 24 sessions with primary and final evaluations. Individual psychotherapy sessions are held per week, each session lasting 45 minutes. Psychodynamic interventions are performed based on McCullough’s treatment Manual. This type of treatment consists of three main parts: defenses restructuring, affect restructuring and restructuring of sense of self/others.
Category
Behavior
2
Description
Control group: The control group receives no intervention for 24 weeks
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
counseling clinic at Hamedan university of medical scienses
Full name of responsible person
Soheila Panahi
Street address
Pazhouhesh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838737
Phone
+98 81 3838 1047
Email
soheilapanahi58@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Famide Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838737
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Saber Esmkhani Akbari Nezhad
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Pazhouhesh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838737
Phone
+98 81 3838 1047
Email
saber.smkhani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehriar Nadder Mohammadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
university Ave
City
Ardabil
Province
Ardabil
Postal code
518985991
Phone
+98 45033522247
Email
m.nadermohammadi@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of Physiology and Neurophysiology Research Center, Faculty of Medicine, Hamadan University of Medical Sciences, Opposite the Mardum Park, Shahid Fahmideh Blvd., Mahdieh Street, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838737
Phone
+98 81 3838 0160
Fax
+98 81 3838 0208
Email
zarei@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Final results will be shared
When the data will become available and for how long
Start the access period 3 months after printing
To whom data/document is available
Academic and non-academic researchers
Under which criteria data/document could be used
Conduct interventional research
From where data/document is obtainable
Academic responsible of research
What processes are involved for a request to access data/document
Sending request for data access
Duration of data sending is 1 month