The aim of this study was to compare the efficacy of metacognitive therapy (MCT) and Cognitive-Behavior therapy in treating Iranian patients with MDD. Method: Thirty-Three outpatients meeting DSM-IV-TR criteria for MDD without any other axis I and II disorder will randomly assigned to one of three treatment conditions: MCT, CBT and Pharmacotherapy treatment. The Beck Depression Inventory-II-Second Edition (BDI-II), Beck Anxiety Inventory (BAI), Metacognitions Questionnaire-Short Form (MCQ-30), Ruminative Response Scale (RRS) and Dysfunctional Attitude Scale (DAS) will administered at pre-treatment, post-treatment and Follow-up. Data were analyzed by repeated measure ANOVA
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108147328N1
Registration date:2011-12-24, 1390/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-24, 1390/10/03
Registrant information
Name
Ahmad Ashouri
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1585
Email address
ahmad.ashouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran university of medical science-Tehran psychiatric institute and ,mental health research center
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Metacognitive Therapy (MCT) Effectiveness and Cognitive-Behavioral Therapy (CBT) in Patients with Major Depressive Disorder (MDD)
Public title
Comparison of Metacognitive Therapy (MCT) Effectiveness and Cognitive-Behavioral Therapy (CBT) in Patients with Major Depressive Disorder (MDD)
Purpose
Treatment
Inclusion/Exclusion criteria
]Inclusion criteria: Having diagnosis criteria for MDD based on the psychiatrist and psychologist ;diagnoses through diagnostic interview and results of the SCID-I/CV test;Receiving no psychological therapies during six months before participation in the study; Being at least 18 aged to 50; Having at least third level of guidance school; Signing the letter of satisfaction by the patients for participating in the study;
Exclusion criteria:
Having psychotic symptoms; drug abuse and other psychological disorders placed at Axis I plus having serious suicidal thought as they could not receive and maintain medications; Having complete criteria of personality disorder at Axis II by psychiatrist and psychologist diagnoses through diagnostic interview and results of the SCID-II test.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
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
Tehran University of Medical Science/Ethics Committee
Street address
Ghods St, Keshavarz Bvd, Tehran, Iran, I. R.
City
Tehran
Postal code
Approval date
2011-07-02, 1390/04/11
Ethics committee reference number
130/727/90/D
Health conditions studied
1
Description of health condition studied
Major Depression Disorder
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Depression Severity
Timepoint
pre-test-post-test-follow-up
Method of measurement
BDI-II
2
Description
Anxiety
Timepoint
pre-test-post-test-follow-up
Method of measurement
BAI
3
Description
Rumination
Timepoint
pre-test-post-test-follow-up
Method of measurement
ruminative response scale (RRS)
4
Description
Metacognitive Beliefs
Timepoint
pre-test-post-test-follow-up
Method of measurement
Metacognitions Questionnaire-Short Form (MCQ-30),
5
Description
Dysfunctional Attitde
Timepoint
pre-test-post-test-follow-up
Method of measurement
Dysfunctional Attitude Scale (DAS)
Secondary outcomes
empty
Intervention groups
1
Description
exprimental groups
1- metacognitive therapy
8 session
Category
Treatment - Other
2
Description
control : pharmachotherapy
Category
Treatment - Drugs
3
Description
Experimental Group 2
Cognitive Behavior Therapy
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Psychiatric Institue
Full name of responsible person
Maryam AliMohammadi
Street address
Tehran Psychiatric Institue, Niayesh St, Sattarkhan Ave, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Taban Health & Diabet Clinic
Full name of responsible person
Street address
Taban Health & Diabet Clinics, Derakhti Blvd, Tehran, Iran
City
Tehran
3
Recruitment center
Name of recruitment center
Private Office of Psychiatry and Clinical Psychology