Determining the effectiveness of psychodynamic psychotherapy of depression on the severity of symotoms, dsability, and object representation
Design
A clinical trial with a single-case design, multiple baselines (different people), without a control group, without randomization and without blinding, on five purposefully selected patients.
Settings and conduct
intervention is performed for patients with major depressive disorder at Shahid Dr. Beheshti Hospital in Zanjan city on an individual basis and in 24 sessions. Also, patients will be evaluated by at least two people.
Participants/Inclusion and exclusion criteria
inclusion: patients aged 18 to 40 who have received a diagnosis of major depressive disorder; If he receives medicine, the dose of medicine should be fixed; Not participating in other psychotherapy in the last month and during treatment.
exclusion: existence of bipolar, psychotic, personality and substance abuse disorders; suicidal tendencies; Physical illness
Intervention groups
The intervention group consists of five patients with major depressive disorder. The logic of the design is that every patient in the baseline and follow-up phase who does not receive intervention is compared with himself; In other words, each person is his own control group.
The intervention consists of short-term psychodynamic treatment for 24 sessions according to the treatment manual of Bush et al.
This treatment is performed twice a week, each session lasts 45 minutes. In this treatment, the main focus is on the narcissistic vulnerability. The unconscious substrates of vulnerabilities are interpreted in treatment sessions.
Depression symptoms are assessed for comparison with the intervention phase one month before the treatment (baseline phase) and one month after the termination of the treatment (follow-up phase).
Main outcome variables
Severity of major depressive disorder symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230228057566N1
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Mazaher Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4001
Email address
mazrez@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The mediating role of object representation transformation for improvement of depression in short-term psychodynamic psychotherapy
Public title
The effectiveness of short-term psychodynamic psychotherapy in major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 40 who have been diagnosed with depression
Proficiency in Persian language
If they receive medication, the dose of medication should be fixed
Willingness to treat with a psychodynamic approach
Not receiving other psychotherapy in the last month and during treatment
Ability to fully attend 20 to 40 treatment sessions
Patients' satisfaction and interest in participating in the study
Exclusion criteria:
Existence of bipolar, psychotic, personality and substance abuse disorders
Suicidal tendencies
Physical illness
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:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Shahid Dr. Beheshti Educational, Therapeutic and Psychiatric Center, Ark Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Approval date
2023-02-14, 1401/11/25
Ethics committee reference number
IR.ZUMS.REC.1401.345
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Severity of major depressive disorder symptoms
Timepoint
Depression symptoms during the treatment phase and also for comparison with the intervention phase, one month before the treatment (baseline phase) and one month after the end of the treatment (follow-up phase) are evaluated once a week.
Method of measurement
beck depression scale, hamilton depression scale
Secondary outcomes
1
Description
Disability due to major depressive disorder
Timepoint
Disability due to major depressive disorder during the treatment phase and also for comparison with the intervention phase is assessed once a month one month before the treatment (baseline phase) and one month after the end of the treatment (follow-up phase).
Method of measurement
Sheehan Disability Scale
2
Description
object relation
Timepoint
Object relations during the treatment phase and also for comparison with the intervention phase is assessed once a month one month before the treatment (baseline phase) and one month after the end of the treatment (follow-up phase).
Method of measurement
Bell Object Relations and Reality Testing Inventory (BORRTI)
Intervention groups
1
Description
The intervention group consists of five patients with major depressive disorder. The logic of the design is that every patient in the baseline and follow-up phase who does not receive intervention is compared with himself; In other words, each person is his own control group.The intervention consists of short-term psychodynamic treatment for 24 sessions according to the treatment manual of Bush et al.This treatment is performed twice a week, each session lasts 45 minutes. In this treatment, the main focus is on the narcissistic vulnerability. The unconscious substrates of vulnerabilities are interpreted in treatment sessions.Depression symptoms are assessed for comparison with the intervention phase one month before the treatment (baseline phase) and one month after the termination of the treatment (follow-up phase).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dr. Beheshti Hospital
Full name of responsible person
Dr Mazaher Rezaei
Street address
Shahid Dr Beheshti Educational, Therapeutic and Psychiatric Center, Ark Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
mazrez@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Samad Nadri
Street address
Zanjan University of Medical Sciences , Dr.Sobouti Blvd. Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8671
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr Mazaher Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Dr. Beheshti Educational, Therapeutic and Psychiatric Center, Ark Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Email
mazrez@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Mazaher Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Dr. Beheshti Educational, Therapeutic and Psychiatric Center, Ark Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Email
mazrez@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Mazaher Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Dr. Beheshti Educational, Therapeutic and Psychiatric Center, Ark Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Email
mazrez@zums.ac.ir
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