Determining the effectiveness of metacognitive therapy on psychological flexibility and rumination in people with obsessive-compulsive disorder.
Design
Unblinded, randomized, controlled clinical trial on 30 patients.
Settings and conduct
First, after obtaining the necessary permits from the university and submitting them to the relevant centers, from the statistical population, those who met the criteria for entering the study will enter the pre-test stage and in this stage will answer the psychological flexibility questionnaire and the rumination questionnaire. From among the people who participated in the pre-test stage, 30 people will be selected purposefully and randomly placed in two experimental groups (15 people) and control groups (15 people). The experimental group will be trained in 8 120-minute sessions twice a week for 1 month, and the control group will not receive any training. After the end of the treatment sessions in the post-test stage, the subjects will answer the research questionnaires and the results obtained from the research questionnaires in the pre-test and post-test stages will be delivered to the statistician for statistical analysis and examination of the research hypotheses.
Participants/Inclusion and exclusion criteria
All people with obsessive-compulsive disorder who referred to psychological clinics in Semnan in the second half of 1403
Intervention groups
The experimental group will receive metacognitive therapy training based on the Wells Protocol (2009) in 8 120-minute sessions, twice a week, for 1 month.
The control group will not receive any intervention.
Effectiveness of metacognitive therapy on psychological flexibility and rumination in people with obsessive-compulsive disorder.
Public title
Effectiveness of metacognitive therapy on psychological flexibility and rumination in people with obsessive-compulsive disorder.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not participating in any psychological intervention at the same time
Having symptoms of obsessive-compulsive disorder for at least 6 months
Willingness to collaborate in research
Minimum literacy
Age range 25 to 60
Exclusion criteria:
Participation in other psychological interventions
Age range: less than 25 years and more than 60 years
Having other psychological illnesses
Age
From 25 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Among the people who participated in the pre-test phase, 30 people were selected using purposive sampling (gender-equality was considered) from among those whose scores were one standard deviation lower than the mean scores on the Psychological Flexibility Questionnaire and one standard deviation lower than the mean scores on the Rumination Questionnaire and were randomly assigned to two experimental groups (15 people) and control groups (15 people).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Semnan Branch
Street address
5th kilometer of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
35131337111
Approval date
2024-07-30, 1403/05/09
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.071
Health conditions studied
1
Description of health condition studied
obsessive-compulsive disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
psychological flexibility
Timepoint
Before the intervention (pre-test) and after the intervention (post-test)
Method of measurement
Ben-Itzhak, Blevstein, and Moore's Psychological Flexibility Questionnaire (2014)
2
Description
rumination
Timepoint
Before the intervention (pre-test) and after the intervention (post-test)
Method of measurement
Nolen Hoeksma and Maru's Rumination Questionnaire (1991)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group will receive metacognitive therapy training based on the Wells Protocol (2009) in 8 120-minute sessions, twice a week, for 1 month.
Category
Rehabilitation
2
Description
Control group: will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Empathy Counseling Center
Full name of responsible person
Islamic Azad University, Semnan Branch
Street address
5th kilometer of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3165 6565
Email
Esmaeilzadeh50@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Esmaeilzadeh Barzi
Street address
5th kilometer of Semnan-Damghan road
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3165 6565
Email
Esmaeilzadeh50@gmail.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
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
Islamic Azad University
Full name of responsible person
Kosar Alizade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 15, Negin 19 Ave., Sanaati saz Modiran Khalegh 2 St.
City
Semnan
Province
Semnan
Postal code
3514433673
Phone
+98 23 3349 2476
Email
kosar.alizade.kosar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kosar Alizade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 15, Negin 19 Ave., Sanaati saz Modiran Khalegh 2 St.
City
Semnan
Province
Semnan
Postal code
3514433673
Phone
+98 23 3349 2476
Email
kosar.alizade.kosar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kosar Alizade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 15, Negin 19 Ave., Sanaati saz Modiran Khalegh 2 St.
City
Semnan
Province
Semnan
Postal code
3514433673
Phone
+98 23 3349 2476
Email
kosar.alizade.kosar@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
Only the results obtained from data and statistical analysis can be shared.
When the data will become available and for how long
From 1404 for one year
To whom data/document is available
Psychologists, psychiatrists, people with obsessive-compulsive disorder, their caregivers, and clinics and counseling and psychology centers
Under which criteria data/document could be used
To expand research on the presented topic.
From where data/document is obtainable
Kosar Alizade: kosar.alizade.kosar@gmail.com
What processes are involved for a request to access data/document
After sending an email to the email address provided, describing the data requirement and reviewing it, it will be sent to the requester within 2 to 4 weeks and if approved by the responsible person.