Protocol summary

Study aim
Comparison Effectiveness of acceptance and commitment therapy with exposure and response prevention and schema therapy with exposure and response prevention on intensity of obsession, obsession beliefs, experiential avoidance, perfectionism and psychological distress in patients with obsession compulsion disorder.
Design
The present study is a unblinded clinical trial with parallel groups. This research has 2 experimental groups and one control group and will be performed on 54 patients (60 people are selected due to the possibility of dropping out). Patients are selected as available and assigned to three groups by simple random and using a table of random numbers.
Settings and conduct
After summons, a clinical interview will be taken from the patients who are eligible, and a pre-test will be taken. This study will be conducted in Isfahan city, Iran, And the meetings will be held at the Parsian Clinic.
Participants/Inclusion and exclusion criteria
Entry criteria: Female sex; People who have been diagnosed with obsessive-compulsive disorder; People who have low or sufficient insight into their OCD disorder; People whose score in the Yale Brown test is less than 25; People whose onset of OCD symptoms is less than two years; Minimum education is 12th grade Exit criteria: Existence of other coexisting disorder; presence of other parallel psychiatric treatments; People who have delusional belief
Intervention groups
The first experimental group is acceptance and commitment therapy with exposure and response prevention. The second group includes schema therapy with exposure and response prevention. The third group is the control group and does not receive any interventions.
Main outcome variables
Intensity of obsession, obsessive beliefs, experiential avoidance, perfectionism

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230119057157N1
Registration date: 2023-02-15, 1401/11/26
Registration timing: prospective

Last update: 2023-02-15, 1401/11/26
Update count: 0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Mahnaz Ghatreh Samani
Name of organization / entity
The University of Semnan
Country
Iran (Islamic Republic of)
Phone
+98 31 3780 3703
Email address
mahnaz.samani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Effectiveness of acceptance and commitment therapy with exposure and response prevention and schema therapy with exposure and response prevention on obsession, experiential avoidance, perfectionism and psychological distress in patient with obsession and compulsion disorder
Public title
The Comparison Effectiveness of acceptance and commitment therapy with exposure and response prevention and schema therapy with exposure and response prevention on obsession compulsion disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of obsessive-compulsive disorder Minimum education is12th grade People whose insight into their disorder is good or sufficient, and low People whose score in the Yale Brown Questionnaire is less than 25 People whose duration of obsessive-compulsive disorder is less than 2 years People whose obsessive-compulsive disorder is not so severe as to impair their cognition
Exclusion criteria:
The presence of other coexisting disorders Other parallel psychiatric treatments People whose disorder is so severe that their cognition is impaired People who have no insight into their disorder or have delusional beliefs
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning people to groups is simple random. After selecting people as samples, a list of them is prepared (For example, 01,02, … ,60), Then, in the random number table, a row and a column are randomly selected and their intersection is determined as the starting point. It is predetermined whether the direction of reading the numbers is left, right, up or down and which two digits of the number in the random number table determine each person's number (for example, the middle two digits). After selecting 20 people for the first group, 20 people for the second group, and 20 people for the third group, the next step is assigning the groups. First, the names of the groups are written on 3 separate papers and they are folded 4 times so that there is no view of the writings. The papers are put in a container and place them randomly in separate folders with three different colors, green, yellow and red. At this stage, the researcher does not know what group is inside each folder. Green, yellow and red colors are written on the other three papers and they are folded 4 times. they are put into a container and the papers are randomly selected and the groups are determined. For example, if the first lottery was green and in the green folder was schema therapy with exposure and response prevention, the people who were selected in the first group with random number table will be placed in the schema therapy with exposure and response prevention group.
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 Committees of Semnan University Of Medical Sciences and Health Services
Street address
Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.SEMUMS.REC.1401.254

Health conditions studied

1

Description of health condition studied
obsession compulsion disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
severity of obsession compulsion disorder
Timepoint
before and after intervention
Method of measurement
Yale Brown Questionnaire

Secondary outcomes

1

Description
Obsessive Beliefs
Timepoint
before and after intervention
Method of measurement
The Obsessive Beliefs Questionnaire

2

Description
Perfectionism
Timepoint
before and after intervention
Method of measurement
Frost Multidimensional Perfectionism Scale

3

Description
Experiential Avoidance
Timepoint
before and after intervention
Method of measurement
Acceptance and Action Questionnaire-II

4

Description
psychological distress
Timepoint
before and after intervention
Method of measurement
Depression Anxiety and Stress Scale

Intervention groups

1

Description
The first intervention group: acceptance and commitment therapy with exposure and response prevention. This treatment consists of 8 sessions and is held every week for 45 minutes. The goals of this therapy include increasing psychological flexibility, Decreased experiential avoidance, Teaching mindfulness exercises to observe thoughts and anxiety, Non-judgment to inner experiences, Creating a hierarchy of compulsive activities and tendency to experience discomfort, Clarification and classification of values ​​and exposure and response prevention based on values, Removing barriers to exposure and response prevention, Practicing uncertainty and incompleteness and creating meaningful moments and daily commitment to values, Increasing the quality of life and preventing relapse and modifying lifestyle.
Category
Other

2

Description
The second intervention group: schema therapy with exposure and response prevention, This treatment consists of 8 sessions and is held every week for 45 minutes. The treatment will include three parts: introduction and familiarization, change and the final part. Treatment goals include identifying primary maladaptive schemas, Creating a hierarchy of obsessions and hierarchical exposure and response prevention during treatment, Adjustment of primary maladaptive schemas, Transferring new learned skills from the treatment to the home environment, Prevent recurrence. In order to achieve the therapeutic goals, the technique of empty chair, the technique of rewriting painful images and memories and schematic notes are used.
Category
Other

3

Description
Control group: At first This group completes the pre-test and does not receive any intervention and remains on the waiting list. After the end of the sessions of the experimental groups, post-test will be taken from this group. In order to comply with research ethics, After completing the intervention in the experimental groups, the control group will receive intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Parsian Clinic
Full name of responsible person
Mahnaz Ghatreh Samani
Street address
Before Malek Ave. ,Sharif vaghfi Ave.
City
Isfahan
Province
Isfehan
Postal code
8154714461
Phone
+98 913 007 7181
Email
mahnaz.samani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of Semnan
Full name of responsible person
Mohammad Hossein Ehsani
Street address
Central Organization of Semnan University, across from Sokan Park
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3365 4138
Email
ehsani@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Semnan
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
The university of Semnan
Full name of responsible person
Mahnaz Ghatreh Samani
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 33, Golshan Ave., Golzar 3 Ave., Zobahan Highway
City
Isfahan
Province
Isfehan
Postal code
8178677553
Phone
+98 31 3780 3703
Email
mahnaz.samani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The university of Semnan
Full name of responsible person
Mahnaz Ghatreh Samani
Position
Ph. D. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 33, Golshan Ave., Golzar Ave., Zobahan Highway
City
Isfahan
Province
Isfehan
Postal code
8178677553
Phone
+98 31 3780 3703
Email
mahnaz.samani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The university of Semnan
Full name of responsible person
Mahnaz Ghatreh Samani
Position
Ph. D. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 33, Golshan Ave., Golzar 3 Ave., Zobahan Highway
City
Isfahan
Province
Isfehan
Postal code
8178677553
Phone
+98 31 3780 3703
Email
mahnaz.samani@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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Title and more details about the data/document
All participant's information will be shared but their names will be removed.
When the data will become available and for how long
The access starts one year after the publication of the results
To whom data/document is available
Only faculty members in psychology
Under which criteria data/document could be used
Meta-analysis is allowed
From where data/document is obtainable
Send request to this email: mahnaz.samani@gmail.com
What processes are involved for a request to access data/document
Data will be sent within two weeks after request
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