The effectiveness of metacognitive therapy on dysfunctional attitude, cognitive regulation of emotion and cognitive flexibility in patients with generalized anxiety disorder
The purpose of the present study is to determine the effectiveness of metacognitive therapy on dysfunctional attitude, cognitive regulation of emotion and cognitive flexibility in patients with generalized anxiety disorder
Design
A clinical trial with a control group, with parallel, blinded, randomized groups, on 32 patients, was selected to randomize the control group and the control group as one among the participants
Settings and conduct
This study will be conducted in Zare Hospital in Sari. Before the study and immediately after the intervention, the control and experimental groups will complete the questionnaires of believability of anxious thoughts and feelings, tolerance of emotional distress and medication adherence
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1 having informed consent and the ability to participate in treatment sessions 2 having generalized anxiety disorder (getting a score higher than the cut-off point on the generalized anxiety disorder scale (GAD 7) and initial clinical interview) 3 having literacy and writing 4 having Being between the ages of 18 and 50 years old 5 In need of drug treatment Exclusion criteria: 1 People with a history of psychotic and psychotic symptoms diagnosed by a psychiatrist 2 A history of hospitalization in a psychiatric hospital 2 Simultaneous alcohol consumption and substance abuse disorder 3 Major psychiatric disorders such as depression basic, bipolar disorder, major cognitive disorders 4 suffering from a significant physical illness 5 participating in psychotherapy sessions at the same time
Intervention groups
The experimental group will receive metacognitive therapy in 8 sessions and the control group will not receive training
Main outcome variables
Dysfunctional attitude, cognitive regulation of emotion and cognitive flexibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231211060334N1
Registration date:2024-03-17, 1402/12/27
Registration timing:registered_while_recruiting
Last update:2024-03-17, 1402/12/27
Update count:0
Registration date
2024-03-17, 1402/12/27
Registrant information
Name
Maedeh Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 3556
Email address
maedehrezaeii1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-04-08, 1403/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of metacognitive therapy on dysfunctional attitude, cognitive regulation of emotion and cognitive flexibility in patients with generalized anxiety disorder
Public title
Investigating the effect of metacognitive therapy on patients with generalized anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent and the ability to participate in treatment sessions
Having generalized anxiety disorder
Being literate in reading and writing
Having the age of 18 to 50 years
Exclusion criteria:
People with a history of psychotic and psychotic symptoms as diagnosed by a psychiatrist
Simultaneous consumption of alcohol and substance abuse disorder
Major psychiatric disorder such as major depression, bipolar disorder, major cognitive impairment
Suffering from a significant physical illness
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:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 32 people are selected using GPOWER software in an accessible way. Then random replacement is done by lottery method (one number is assigned to each sample). We write down the numbers on the paper, fold them and put them in the container. We mix and stir the papers completely. Then we take out the papers one by one and put one number in the first group and one number in the second group. Then random application will be done. In this way, one group is known as "control group" and the other group is known as "intervention group". The lottery will be done by putting the two groups obtained from the previous step (random replacement step) into two separate envelopes and placing them in a container.Then we randomly take out an envelope that contains 16 numbers from the container and assign it to the "intervention group" and the other envelope that also contains 16 numbers to the "control group". Finally, the intervention group receives 8 sessions of 120 minutes of metacognitive therapy for generalized anxiety disorder and the second group, as a control group, does not receive any psychological treatment
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 Sari Azad University of Medical Sciences
Street address
Km 7 Darya Road, Sari
City
Sari
Province
Mazandaran
Postal code
48164194
Approval date
2023-11-14, 1402/08/23
Ethics committee reference number
IR.IAU. SARI.REC .1402. 261
Health conditions studied
1
Description of health condition studied
Patients with generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Dysfunctional Attitude
Timepoint
Before the study and immediately after the intervention
Method of measurement
The dysfunctional attitude variable that was used to measure Iseman and Beck-26 dysfunctional attitude questionnaire
2
Description
Cognitive regulation of emotion
Timepoint
Before the study and immediately after the intervention
Method of measurement
The variable of cognitive regulation of emotion which was used to measure this variable from the short form questionnaire of Garnevsky's cognitive regulation Graij
3
Description
Cognitive flexibility
Timepoint
Before the study and immediately after the intervention
Method of measurement
Cognitive flexibility variable that was used to measure the flexibility questionnaire of Dennis and Nedroval
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In this plan, there is an experimental group and a control group. Before the intervention, pre-tests of dependent variables of believability of anxious thoughts and feelings, tolerance of emotional distress and adherence to medication will be performed on the research participants. After this stage, the participants of the experimental group will receive 8 120-minute sessions of metacognitive therapy for generalized anxiety, and the control group will not receive any training. Then, the participants of the test groups and the post-test certificate will be done. The content of the sessions is as follows: 1: conducting the pre-test, preparing and introducing metacognitive therapy, presenting the logic of metacognitive therapy. 2: Familiarizing with attentional cognitive syndrome and how it affects the persistence of mental disorders, questioning about the effectiveness of self-regulatory (adversarial) behaviors, testing suppression of thoughts3: Challenge with negative metacognitive beliefs related to the uncontrollability of ruminations, negative thoughts and emotions, teaching dissociative mindfulness practice, dissociative mindfulness practice about neutral thoughts. 4: Continuing the challenge with uncontrollability belief (examination of contrary evidence), conducting experiments to Postponing ruminations, performing the test of loss of control in the treatment session. 5: Challenge with metacognitive beliefs related to the uncontrollability of risk and harm, familiarization with verbal methods and behavioral tests. 6: Challenge with positive metacognitive beliefs, presenting a mismatch strategy. and dissonance, performing a rumination moderation test.7: Presenting a new processing program including: identifying the process of ruminations, anxieties, stresses, emotions and worries, emphasizing the use of detached awareness for stimulating thoughts, allowing emotions and ruminations to rise and fall without trying to investigate them, repeated implementation New styles of thinking. 8: Monitoring progress, providing a summary of the techniques presented in all therapy sessions, answering questions and problems in applying these techniques, getting feedback from all sessions, performing post-tests
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare burn and psychiatric hospital
Full name of responsible person
Amirkeivan Maroufi
Street address
Zare Psychiatry and Burns Hospital, km 3 of Sari Neka Road, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3328 3886
Email
zarehospital@mazums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abdullah Mirghiyashi
Street address
5th floor-Humanities Buildin-Farah Abad Road, Azad University-Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3303 2891
Email
h_kermanian@sbu.ac.ir
Web page address
https://sari.iau.ir/fa
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
90
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghodrat aloha Abbasi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
5th floor-Humanities Buildin-Farah Abad Road, Azad University-Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3303 2891
Email
gh_abbasi@iausari.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Godrato lah Abbasi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
5th floor-Humanities Buildin-Farah Abad Road, Azad University-Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3303 2891
Email
gh_abbasi@iausari.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghodratolah Abbasi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
5th floor-Humanities Buildin-Farah Abad Road, Azad University-Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3303 2891
Email
gh_abbasi@iausari.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
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
No - There is not 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
The main results will be shared after the end of the study
When the data will become available and for how long
6 months
To whom data/document is available
Upon request, the study results will be made available to other academic researchers
Under which criteria data/document could be used
The collected data is confidential and will not be shared with others
From where data/document is obtainable
To receive documents, send an email to the person responsible for updating gh_abbasi@iausari.ac.ir
What processes are involved for a request to access data/document
Within 15 days, the documents will be sent by email