Evaluation of efficacy for group-therapy of a package based on Goal Management Training and Metacognitive Therapy among patients with obsessive-compulsive disorder for improving cognitive functions and reducing symptoms severity
Comparison of efficacy for group-therapy of a package based on Goal Management Training and Metacognitive Therapy among patients with OCD for improving cognitive functions and reducing symptoms severity with wait-list
Design
Two arm parallel group randomized trial (group-therapy intervention and wait-list). Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks.To do study with concealment, table of block will be used by one of researchers, other than interviewer, to write number of each participants in an envelope.
Settings and conduct
OCD outpatients from clinics of IUMS will be recruited. Patients who meet DSM-5 criterion for OCD and they achieve more than 17 for Y-BOCS Scale.
Participants/Inclusion and exclusion criteria
18-65yo old patients with OCD and they achieve more than 17 for Y-BOCS Scale are suitable for study.They have been on a stable dose of OCD medication for a minimum of 8 weeks before the study, if applicable.
Exclusion criteria:(1)concurrently meet DSM-5-TR criteria for a severe mood disorder, substance abuse/dependence(other than nicotine and caffeine), schizophrenia, or other psychotic disorders;(2)have a organic impairment or suspected organic pathology;(3)have active medical comorbidity that might require necessary intervention during the trial;(4)have a history of medical disorders known to significantly affect cognition (such as heart disease) in the past year; (5)have a history of traumatic brain injury, loss of consciousness, or concussion; (6)receive treatments known to significantly affect cognition (such as anticholinergic agents or receiving ECT in the past 6 months)
Intervention groups
The initial three of the eight sessions will focus on metacognitive therapy, and the last five will focus on goal management training. Each session will last two hours.
Main outcome variables
Severity of OCD and cognitive functions
General information
Reason for update
Acronym
OCD
IRCT registration information
IRCT registration number:IRCT20170123032145N8
Registration date:2025-01-19, 1403/10/30
Registration timing:prospective
Last update:2025-01-19, 1403/10/30
Update count:0
Registration date
2025-01-19, 1403/10/30
Registrant information
Name
Mohammadreza Shalbafan
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1665
Email address
shalbafan.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-05, 1404/01/16
Expected recruitment end date
2026-03-19, 1404/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy for group-therapy of a package based on Goal Management Training and Metacognitive Therapy among patients with obsessive-compulsive disorder for improving cognitive functions and reducing symptoms severity
Public title
Cognitive rehabilitation for patients with OCD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who meet DSM-5 criterion for OCD and they achieve more than 21 for Yale-Brown Obsessive Compulsive Scale are suitable for study.They should be 18-65 year old. They should sign the consent form. have been on a stable dose of OCD medication for a minimum of 8 weeks before the study, if applicable.
Exclusion criteria:
(1) concurrently meet DSM-5-TR criteria for a severe mood disorder, substance abuse/dependence (other than nicotine and caffeine), schizophrenia, or other psychotic disorders; (2) have a organic impairment or suspected organic pathology; (3) have active medical comorbidity that might require necessary intervention during the trial; (4) have a history of medical disorders known to significantly affect cognition (such as heart disease) in the past year; (5) have a history of traumatic brain injury, loss of consciousness, or concussion; (6) receive treatments known to significantly affect cognition (such as anticholinergic agents or receiving electroconvulsive therapy within the past 6 months)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks. Therefore, a table including 4: 1 blocks with random allocation of 2 numbers for each group will be given to a person other than recruiter/ evaluator and they will mark the medication box based on this numbers.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-04-22, 1403/02/03
Ethics committee reference number
IR.IUMS.FMD.REC.1403.025
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
Severity of obsessive-compulsive disorder
Timepoint
Months: 0,2,5
Method of measurement
Yale-Brown Obsessive Compulsive Scale(YBOCS)
2
Description
Neurocognitive Functions
Timepoint
Months: 0,2,5
Method of measurement
Conners’ Continuous Performance Task , The Stroop Color and Word Test , The Tower of London, The California Verbal Learning Test , The Wechsler Test of Adult Reading
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The initial three of the eight sessions will focus on metacognitive therapy, and the last five will focus on goal management training. Each session will last two hours.
Category
Treatment - Other
2
Description
Control group:Patients in waiting list.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Dr Mohammadreza Shalbafan
Street address
Tehran- Karaj Highway 7 km
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3395
Email
Shalbafan.mr@iums.ac.ir
Web page address
http://iph.iums.ac.ir/
2
Recruitment center
Name of recruitment center
Brain and Cognition Clinic
Full name of responsible person
Dr Mohammadreza Shalbafan
Street address
No 33, E. Zartosht, Valiasr St.
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8880 2065
Email
Shalbafan.mr@iums.ac.ir
Web page address
https://bcclinic.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Reza Falak
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mhrc@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Cognitive Sciences and Technologies Council
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Shalbafan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hemmat Exp. way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
shalbafan.mr@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Shalbafan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hemmat Exp. way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
shalbafan.mr@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Shalbafan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hemmat Exp. way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
shalbafan.mr@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data about main outcome of study will be published
When the data will become available and for how long
2027
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
For scientific goals
From where data/document is obtainable
shalbafan.mr@iums.ac.ir Dr Mohammadreza Shalbafan
What processes are involved for a request to access data/document