Protocol summary

Summary
The present research aimed to analyze the efficacy of Metacognitive group therapy (MCT) on self-esteem and Mental Health of those who suffer from Major depressive Disorder (MDD). The study population is MDD patients who refer to Ibn-e-Sina and Ghaem hospital of Mashhad. In a clinical trial, available Sampling method was taken to choose 30 patients randomly allocated in two groups (experiment and Control). Two groups took SSRIs (Citalopram or Sertraline) as standard treatment. Experiment group patients went under MCT Treatment. Eysenck Self-esteem and Mental Health Checklist (MHC) were used in pre-test, post-test and 2-month follow-up as the study instrument.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201162611N3
Registration date: 2012-02-10, 1390/11/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-10, 1390/11/21
Registrant information
Name
Mohammad Reza Fayyazi Bordbar
Name of organization / entity
Psychiatry and Bahavioral Sciences Research Center, Psychiatry group, Mashhad University of Medical
Country
Iran (Islamic Republic of)
Phone
00985117112721 , 00985117002306
Email address
fayyazimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Sari Branch
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-10-15, 1390/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Group Metacognitive therapy on self-esteem & mental health of the patients suffering from major depression disorder
Public title
The efficacy of Group Metacognitive therapy on self-esteem & mental health of the patients suffering from major depression disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Meeting DSM-IV-TR criteria's of MDD; informed consent; Diploma or higher education; No any other psychological therapy at least during the 2 previous years. Exclusion criteria: borderline personality disorder; receiving any other simultaneous psychological intervention; psychosis; drug abuse or dependency.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Islamic Azad University Sari Branch
Street address
Islamic Azad University Sari Branch, 25 kilometers sea street
City
Sari
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
25/05/1389

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms

Primary outcomes

1

Description
Self esteem
Timepoint
Before the intervention, after intervention, 2 months after of intervention
Method of measurement
Eysenck Self esteem Test

2

Description
Mental health
Timepoint
Before the intervention, after of intervention, 2 months after of intervention
Method of measurement
Mental health Checklist

Secondary outcomes

empty

Intervention groups

1

Description
Pharmacotherapy (Citalopram: starting dose of 10 mg and increased to the maximum 40 mg per day, and sertraline: starting dose 50 mg and increased to a maximum of 150 mg.)
Category
Treatment - Drugs

2

Description
Metacognitive Group therapy (5 weeks)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn-e-Sina Hospital
Full name of responsible person
Vahid Farahmand
Street address
Ibn-e-Sina Hospital, Hor-e-Ameli Blvd.
City
Mashhad

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Vahid Farahmand
Street address
Ghaem Hospital, Ahmedabad AV.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Sari Branch
Full name of responsible person
Vahid Farahmand
Street address
Islamic Azad University Sari Branch, 25 kilometers sea street
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Sari Branch
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
Islamic Azad University Sari Branch
Full name of responsible person
Vahid Farahmand
Position
Master of Clinical psychology
Other areas of specialty/work
Street address
Islamic Azad University Sari Branch, 25 kilometers sea street
City
Sari
Postal code
Phone
+98 15121333794
Fax
Email
v.farahmand_psy@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Fayyazi Bordbar
Position
Associate Professor of Psychiatry
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Hor-e-Ameli Blvd.
City
Mashhad
Postal code
Phone
+98 51 1700 2306
Fax
Email
fayyazimr@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Fayyazi Bordbar
Position
Associate Professor of Psychiatry
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Hor-e-Ameli Blvd.
City
Mashhad
Postal code
Phone
Fax
Email
fayyazimr@mums.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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