Protocol summary

Study aim
Comparison of the effect of schema therapy, emotional schema therapy and exposure and prevention of response to rumination, irrational beliefs, guilt, distress tolerance, extreme responsibility, perfectionism, emotion regulation and clinical symptoms in people with obsessive-compulsive symptoms
Design
In this randomized controlled clinical trial, first 60 people with obsessive-compulsive disorder eligible to participate in the study will be selected by available method. Then they will be assigned to three intervention groups and the control group by simple randomization method using a table of random numbers.
Settings and conduct
This study will be performed in Himan counseling and psychological services center in Mashhad. People with obsessive-compulsive disorder who are eligible to enter the study will be invited to study after obtaining written consent. Then, they will be assigned to the three intervention and control groups by simple randomization using a random number table.
Participants/Inclusion and exclusion criteria
Inclusion criteria include obtaining a score of 11 and above from the Maudsley obsessive-compulsive disorder questionnaire and lack of comorbidity with other psychiatric disorders. Exclusion criteria included having a history of substance abuse and having suicidal thoughts and and history of doing so.
Intervention groups
Intervention group 1 received schema therapy based on the treatment protocol of Yang et al. (2003). Intervention group 2 received emotional therapy schema based on Leahy et al. (2016) treatment protocol. Intervention group 3 received exposure and response prevention based on the treatment protocol of Jones et al. (1998). The control group received routine care.
Main outcome variables
Ruminant, irrational beliefs, guilt, distress tolerance, extreme responsibility, perfectionism, emotion regulation and clinical symptoms of obsessive-compulsive disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210511051261N1
Registration date: 2021-07-10, 1400/04/19
Registration timing: registered_while_recruiting

Last update: 2021-07-10, 1400/04/19
Update count: 0
Registration date
2021-07-10, 1400/04/19
Registrant information
Name
Masood Ahowan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3731 6126
Email address
masood.ahvan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-14, 1400/01/25
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of schema therapy, emotional schema therapy and exposure and prevention of response to rumination, irrational beliefs, guilt, distress tolerance, extreme responsibility, perfectionism, emotion regulation and clinical symptoms in people with obsessive-compulsive disorder
Public title
Comparison of the effect of schema therapy, emotional schema therapy and exposure and prevention of response in obsessive-compulsive clinical disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Diagnosis of Obsessive-Compulsive Disorder Based on Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition Obtaining a score of 11 and above from the Maudsley obsessive-compulsive disorder questionnaire Have at least a third level of secondary education Lack of comorbidity with other psychiatric disorders Lack of having other physical diseases Not receiving psychotherapy and medication for obsessive-compulsive disorder before entering the research
Exclusion criteria:
Having a history of substance abuse Having suicidal thoughts and and history of doing so
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The sample will be selected from the members of the statistical community using the available sampling method based on inclusion and exclusion criteria. Then, they will be assigned to three intervention groups and one control group based on simple randomization sampling method using a random number table. Thus, first, a list of people eligible to participate in the study will be prepared. Then by considering the numbers for different groups (15-00 for intervention group 1, 16-30 for intervention group 2, 31-45 for intervention group 3 and 46-60 numbers for control group) and for moving up and down , Is placed on one of the numbers in the table and the numbers are recorded and the random order of people entering one of the groups will be determined.
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
Research Ethics Committee of Islamic Azad University, Lahijan Branch
Street address
Islamic Azad University of Lahijan, End of Shaghayegh St., East Kashif St.
City
Lahijan
Province
Razavi Khorasan
Postal code
013-41228701
Approval date
2021-04-14, 1400/01/25
Ethics committee reference number
IR.IAU.LIAU.REC.1400.006

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
Rumination
Timepoint
Before intervention, after intervention, six months after intervention
Method of measurement
Ruminant Response Style Questionnaire (RRS)

Secondary outcomes

1

Description
Irrational beliefs
Timepoint
Before intervention, after intervention, one month after intervention, three months after intervention
Method of measurement
Jones Irrational Beliefs Questionnaire (IBT)

2

Description
guilty
Timepoint
Before intervention, after intervention, one month after intervention, three months after intervention
Method of measurement
Kugler & Jones Guilty Questionnaire

3

Description
Tolerance of distress
Timepoint
Before intervention, after intervention, one month after intervention, three months after intervention
Method of measurement
Simons and Gaher Distress Scale (DTS)

4

Description
Extreme responsibility
Timepoint
Before intervention, after intervention, one month after intervention, three months after intervention
Method of measurement
California Accountability Questionnaire

5

Description
Perfectionism
Timepoint
Before intervention, after intervention, one month after intervention, three months after intervention
Method of measurement
Hill et al. Perfectionism Scale (2004)

6

Description
Emotion Regulation
Timepoint
Before intervention, after intervention, one month after intervention, three months after intervention
Method of measurement
Jahn & Gross Emotion Regulation Questionnaire

7

Description
Clinical syndrome of obsessive-compulsive disorder
Timepoint
Before intervention, after intervention, one month after intervention, three months after intervention
Method of measurement
Structured clinical interview for Axis Disorders 1

Intervention groups

1

Description
Intervention group 1: They will receive the therapy schema individually according to the treatment protocol of Young et al. (2003) for 20 sessions, each session lasting 45 minutes.
Category
Treatment - Other

2

Description
Intervention group 2: They will receive emotion therapy schema individually based on Leahy et al. (2016) treatment protocol for 15 sessions, each session lasting 45 minutes.
Category
Treatment - Other

3

Description
Intervention group 3: They will receive exposure and response prevention individually based on the treatment protocol of Jones et al. (1998) for 10 sessions, each session lasting 45 minutes.
Category
Treatment - Other

4

Description
Control group: They will not receive treatment during research.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Himan Counseling and Psychological Services Center
Full name of responsible person
Hossein Haji Baba Kashani
Street address
Himan Counseling and Psychological Services Center, second floor, No. 300, between Piroozi 34 and 36, Piroozi Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9193974364
Phone
+98 51 3884 6116
Email
Himan.Counseling@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamreza Vaghar Lahiji
Street address
Islamic Azad University of Lahijan, End of Shaghayegh St., East Kashif St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9193974364
Phone
+98 13 4122 2602
Email
gholamreza.vaghar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masood Ahovan
Position
PhD in Counseling
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Himan Counseling and Psychological Services Center, second floor, No. 300, between Piroozi 34 and 36, Piroozi Boulevard
City
Mahhad
Province
Razavi Khorasan
Postal code
9193974364
Phone
+98 51 3844 6116
Email
Masood.ahvan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masood Ahovan
Position
PhD in Counseling
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Himan Counseling and Psychological Services Center, second floor, No. 300, between Piroozi 34 and 36, Piroozi Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9193974364
Phone
+98 51 3844 6116
Email
Masood.ahvan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masood Ahovan
Position
PhD in Counseling
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Himan Counseling and Psychological Services Center, second floor, No. 300, between Piroozi 34 and 36, Piroozi Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9193974364
Phone
+98 51 3844 6116
Email
Masood.ahvan@gmail.com

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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Clinical outcomes of the study will be published in the form of a paper.
When the data will become available and for how long
The results of the study will be published at the earliest opportunity after data collection.
To whom data/document is available
Data documentation will be shared in the form of an article.
Under which criteria data/document could be used
The data will be provided to researchers working in academic institutions and counseling centers and psychological services with the permission of the Islamic Azad University of Lahijan.
From where data/document is obtainable
The data will be provided to researchers working in academic institutions and counseling centers and psychological services after receiving permission from the Islamic Azad University of Lahijan.
What processes are involved for a request to access data/document
Researchers must obtain written permission from the Vice Chancellor for Research, Islamic Azad University, Lahijan Branch.
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