This study is a pre and post-examination using random sampling method. The statistical population is all the outpatients in Akhavan clinic and private practicing professors’ offices that are diagnosed with major depression disorder based on DMS-IV-TR criteria. The random sampling was done so that 12 people were selected from all the qualified volunteers for the study. The patients are on SSRI pharmaceutical treatment(Tab sertraline 100mg) as well as psychotherapeutic treatment. Another12 people group on SSRI treatment(Tab sertraline 100mg) are selected as the control group.The severity of depression symptoms is measured in session 1;session 6;session 12 with Beck depression inventory(BDI).The efficasy of emotion regulation psychotherapy in major depression symptoms is compared in two groups at the end of research.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102624711N1
Registration date:2016-01-17, 1394/10/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Azad
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
Email address
azad@irimc.org
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2015-11-16, 1394/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of emotion regulation in patient with major depressive disorder on ssri treatment
Public title
Efficacy of emotion regulation in major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 25 to 45؛ minimum high school diploma education؛ Dominate in persian language psychologicall minded؛ diagnosed with major depression disorder based on DSM-IV TR criteria؛ voluntarily agreement on the study participation
Exclusion criteria: symptoms of neuroticism and mania؛ drug abuse history؛ noticeable suicidal thoughts؛ simultaneous symptoms of borderline personality disorder and anti-social disorder؛ reluctance on continuing the treatment؛ receiving other psychotherapeutic treatments as well as current treatment؛ need for hospitalization or ECT while under treatment
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
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
University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave, daneshjo Blvd, Evin
City
Tehran
Postal code
1985713834
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.USWR.REC.1394.29
Health conditions studied
1
Description of health condition studied
major depressive disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
sadness
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
2
Description
paranoia
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
3
Description
last breakage
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
4
Description
anhedonia
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
5
Description
guilt feeling
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
6
Description
sense of punishment
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
7
Description
self dislike
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
8
Description
self criticism
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
9
Description
suicidal idea or tendency
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
10
Description
crying
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
11
Description
unrest
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
12
Description
loss of interest
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
13
Description
undecision
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
14
Description
worthless
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
15
Description
lack of energy
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
16
Description
sleep disturbance
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
17
Description
irritability
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
18
Description
appetite disturbance
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
19
Description
concentration disturbance
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
20
Description
fatigue
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
21
Description
hyposexuality
Timepoint
session1,session 6,session12
Method of measurement
beck depression inventory
Secondary outcomes
1
Description
emotion regulation
Timepoint
session1,session 12
Method of measurement
emotion regulation questionnaire
Intervention groups
1
Description
We use medical therapy(tab sertraline 100mg/daily)and 12 session emotion regulation psychotherapy in intervention group
Category
Treatment - Other
2
Description
We use only medical therapy(tab sertralin 100mg/daily) in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi psychiatry hospital
Full name of responsible person
Dr.Ali nazeri
Street address
Razi hospital, shahid rastegar blvd, shahrerey
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr.Hamidreza Khanke
Street address
Kodakyar Ave, Daneshjo street, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Azad matari
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Razi hospital, shahid rastegar blvd, shahrerey
City
Tehran
Postal code
1985713834
Phone
+98 21 3340 1220
Fax
+98 21 2218 0109
Email
azad7918@yahoo.com
Web page address
http://www.uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Ali nazeri
Position
Psychiatrist
Other areas of specialty/work
Street address
Razi hospital, shahid rastegar street, shahrerey
City
Tehran
Postal code
1985713834
Phone
+98 912 486 9214
Fax
+98 21 2218 0109
Email
alinazeri_76@yahoo.com
Web page address
http://www.uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences