Protocol summary

Summary
The aim of this study was to compare the effectiveness of metacognitive therapy, fluvoxamine and the combination of metacagnitive therapy with fluvoxamine in treatment of patients with OCD. Inclusion criteria were as follows: (1) diagnosis of OCD according to DSM-IV-TR, (2) age between 18 to 50. Patients were excluded if they had a personality disorder, substance abuse problem and other comorbid axis I disorders. Twenty-one outpatients meeting criteria for OCD without any other axis I and II disorder were randomly assigned to one of three treatment conditions: MCT, fluvoxamine and combined group for 10 weeks of treatment. The demographic Questionnaire, Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Beck Depression Inventory-II-Second Edition (BDI-II), Beck Anxiety Inventory (BAI), Depression Anxiety Stress Scale-21 (DASS-21), Subjective Units of Distress (SUDs), Global Assessment of Functioning (GAF), Metacognitions Questionnaire-Short Form (MCQ-30), Thought Control Questionnaire (TCQ), and Stop Signals Questionnaire (SSQ) were administered blindly at pre-treatment and post-treatment. Y-BOCS, BDI-II, BAI, DASS-21, SUDs and GAF also were administered after session 2, 4, 6 and 8. Nineteen patients completed this study and two patients dropped out from the study. ANCOVA, repeated measure ANOVA, pre- to post improvement percentage, Kruskal Wallis and mann Withney U-test are used to analyze data.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811303372N1
Registration date: 2010-04-26, 1389/02/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-04-26, 1389/02/06
Registrant information
Name
Hossein Shareh
Name of organization / entity
Iran University of Medical Sciences, Tehran Psychiatric Institute; Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1655
Email address
h.shareh@stu.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of the Iran University of Medical Sciences
Expected recruitment start date
2009-09-06, 1388/06/15
Expected recruitment end date
2009-10-07, 1388/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Metacognitive Therapy, Fluvoxamine, or Combination Treatment in Obsessive-Compulsive Disorder: A randomized clinical trial
Public title
Metacognitive Therapy, Fluvoxamine, or Combination Treatment in Obsessive-Compulsive Disorder: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (1) diagnosis of OCD according to DSM-IV-TR, (2) duration of the illness for at least 1 year, (3) age between 18 to 50. Exclusion criteria: (1) currently suicidal or psychotic, (2)have a personality disorder, neurological disease or substance abuse problem and other comorbid axis I disorders, (3) have been receiving other psychological treatment or pharmacotherapy during the previous month.
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: 19
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
Ethics Committee of the Mental Health Research Center, Tehran Psychiatric Institute
Street address
Tehran Psychiatric Institute and Mental Health Research Centre, Shahid Mansoori Alley, Niayesh St., Sattarkhan Ave., Tehran, Iran, IR
City
Tehran
Postal code
Approval date
2009-08-31, 1388/06/09
Ethics committee reference number
07/09/06/88

Health conditions studied

1

Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
obsessive-compulsive symptoms severity
Timepoint
before treatment, every two weeks for 3 months, every 6 months for one years in follow up
Method of measurement
scale

2

Description
Depression severity
Timepoint
before treatment, every two weeks for 3 months, every 6 months for one years in follow up
Method of measurement
Inventory

3

Description
Anxiety severity
Timepoint
before treatment, every two weeks for 3 months, every 6 months for one years in follow up
Method of measurement
Inventory

4

Description
Stress severity
Timepoint
before treatment, every two weeks for 3 months, every 6 months for one years in follow up
Method of measurement
Scale

5

Description
Subjective distress
Timepoint
before treatment, every two weeks for 3 months, every 6 months for one years in follow up
Method of measurement
Scale

6

Description
Global functioning
Timepoint
before treatment, every two weeks for 3 months, every 6 months for one years in follow up
Method of measurement
Scale

Secondary outcomes

1

Description
metacognition components
Timepoint
before and after treatment
Method of measurement
inventory

Intervention groups

1

Description
pharmacotherapy(Fluvoxamine 50-300mg, daily, 10 weeks)
Category
Treatment - Drugs

2

Description
Metacognitive Therapy (10 weeks)
Category
Behavior

3

Description
combination of metacognitive therapy and fluvoxamine(50-300ml daily,10 weeks)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Psychiatric Institute, Sobhe Sadegh Clinic, Taban Polyclinic, Sokhane Ashena Clinic, Psychiat
Full name of responsible person
Hossein Shareh
Street address
Tehran Psychiatric Institute and Mental Health Research Centre, Shahid Mansoori Alley, Niayesh St.,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of the Iran University of Medical Sciences
Full name of responsible person
Dr. Motevalian
Street address
Iran University of Medical Sciences, Hemmat Exp., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of the Iran 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
Iran University of Medical Sciences, Tehran Psychiatric Institute
Full name of responsible person
Hossein Shareh
Position
Ph.D.
Other areas of specialty/work
Street address
Tehran Psychiatric Institute and Mental Health Research Centre, Shahid Mansoori Alley, Niayesh St., Sattarkhan Ave., Tehran, Iran, IR
City
Tehran
Postal code
Phone
+98 21 6655 1655
Fax
Email
h.shareh@stu.iums.ac.ir, hsharreh@gmail.com, hsharreh@yahoo.com.au
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, Tehran Psychiatric Institute
Full name of responsible person
Hossein Shareh
Position
Ph.D.
Other areas of specialty/work
Street address
Tehran Psychiatric Institute and Mental Health Research Centre, Shahid Mansoori Alley, Niayesh St., Sattarkhan Ave., Tehran, Iran, IR
City
Tehran
Postal code
Phone
+98 21 6655 1655
Fax
Email
h.shareh@stu.iums.ac.ir, hsharreh@gmail.com, hsharreh@yahoo.com.au
Web page address

Person responsible for updating data

Contact

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
Loading...