Protocol summary

Summary
The present study is a clinical trial with a pretest-posttest design. After random selection and assignment of samples to control and 2 intervention groups( intervention groups-I and intervention groups-II). Interventions: intervention groups-I: para-cognitive therapy performs on the first intervention group during ten 1-hour sessions (a new method of psychotherapy that is mostly concerned with the effect of depression on thinking process than its content) , In this model, depression is associated with some kinds of Mal-adaptive thinking styles, known as Cognitive-Attention Syndrome. This syndrome is characterized by repetitive thought in the form of anxiety or rumination on a threat and Mal-adaptive coping behaviors. Intervention groups-II: 10-60 mg citalopram ( a standard and widely used antidepressant from SSRI group of antidepressants) will be administer in a daily single dose, the drug will be started 10 mg/day and then will be increased weekly to optimum dose ( 20-60 mg/day). Control group: do not receive any interventions and they will be place on waiting list. All the groups will be evaluate twice (pre-test, post-test ). We invite volunteers to participate in the study from outpatients diagnosed with depression in treatment centers and clinics of Isfahan. Thereafter, the volunteers will be interviewed by psychologists and psychiatrists based on the symptoms proposed by Diagnostic and Statistical Manual of Mental Disorders(DAM-IV-TR) to reach a definitive diagnosis of major depression disorder. The eligible patients randomly divide into three groups of citalopram (n=15), para-cognitive intervention (n=15), and control (n=15). A demographic form, which included items on age, gender, educational level, and occupation, will be used to gather demographic information. The following three questionnaires will be employed in this study, as well. Beck depression inventory-II, para-cognition questionnaire-30, Cognitive emotion regulation questionnaire.

General information

Acronym
Depression and Para-cognition therapy
IRCT registration information
IRCT registration number: IRCT201602012266N5
Registration date: 2016-04-11, 1395/01/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-11, 1395/01/23
Registrant information
Name
Gholamreza Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2135
Email address
kheirabadi@bsrc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2015-08-01, 1394/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of effect of Citalopram and Para-cognition therapy on severity of depression in major depressive disorder
Public title
Effect of para-cognition therapy on depression
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 18-60 years; mild-moderate depression; no psychotic symptoms; no history of mania and hypo-mania; no other axis-I Disorders; completing of consent form Exclusion criteria: Desire to exit from study; increasing the severity of depression and needing to complementary treatments; including to any other treatment modality during study.
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: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
simple (alternate) randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jerib St., Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
394225

Health conditions studied

1

Description of health condition studied
Major Depression
ICD-10 code
f32
ICD-10 code description

Primary outcomes

1

Description
severity of depression
Timepoint
before and after of intervention
Method of measurement
Quwstionair

Secondary outcomes

1

Description
Cognitive emotion regulation
Timepoint
before and after the intervention
Method of measurement
Questionair

Intervention groups

1

Description
intervention groups-I: para-cognitive therapy performs on the first intervention group during ten 1-hour sessions (a new method of psychotherapy that is mostly concerned with the effect of depression on thinking process than its content) ,
Category
Behavior

2

Description
Intervention groups-II: 10-60 mg citalopram ( a standard and widely used antidepressant from SSRI group of antidepressants) will be administer in a daily single dose, the drug will be started 10 mg/day and then will be increased weekly to optimum dose ( 20-60 mg/day(
Category
Treatment - Drugs

3

Description
Control group: do not receive any interventions and they will be place on waiting list.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
khorshid hospital
Full name of responsible person
Gholam Reza Kheirabadi
Street address
behavioral Sciences Resaerch Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
isfsshsn

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Nematbakhsh
Street address
Vice chancellor for research of Isfahan University of Medical Sciences
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza kheirabadi
Position
Assiciate Professor of psychiatry
Other areas of specialty/work
Street address
Behaviora Siecnces Research center, Isfahan University of Medical Sciences
City
Isfahn
Postal code
Phone
+98 31 3222 2135
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Kheirabadi
Position
Associate professor of psychiatry
Other areas of specialty/work
Street address
Behavioral Sciences Research Centre, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3222 2135
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahn University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Kheirabadi
Position
Associate Professor
Other areas of specialty/work
Street address
Behavioral Sciences Resaerch Centre, Isfahn University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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