Determining the effectiveness of cognitive behavioral therapy on cognitive flexibility, rumination and mindfulness in people with depression
Design
The clinical trial has a control group, community-based and practice-oriented, with parallel groups.
Settings and conduct
A clinical trial has been conducted in the field of depression. The statistical population will include all depressed people who refer to Shana and Aram counseling centers in Karaj, and the statistical sample will be selected using available sampling method, from which 30 people will be randomly replaced in each group of 15 people for testing and control. First, the relevant questionnaires will be completed by all participants, and then the intervention group will receive 13 sessions of cognitive-behavioral therapy, and finally, after training, both groups will complete the relevant questionnaires again, and their scores will be The test is recorded.
Participants/Inclusion and exclusion criteria
The conditions for entering the study are depressed people who are between the ages of 20 and 50, and the conditions for not entering are those who are old and do not have the ability to provide appropriate information.
Intervention groups
In addition to the usual interventions in the treatment center, the experimental group is subjected to cognitive-behavioral therapy intervention.
The control group receives only the usual interventions in the treatment center.
Main outcome variables
Cognitive flexibility, rumination, mindfulness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230708058718N1
Registration date:2023-07-16, 1402/04/25
Registration timing:registered_while_recruiting
Last update:2023-07-16, 1402/04/25
Update count:0
Registration date
2023-07-16, 1402/04/25
Registrant information
Name
Masoumeh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7704 0640
Email address
sadeghi2002@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-13, 1402/04/22
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive behavioral therapy on Cognitive flexibility, rumination and mindfulness in people with depression
Public title
The effect of cognitive behavioral therapy on cognitive flexibility, rumination and mindfulness in depressed people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All depressed people who are between 20 and 50 years old
Exclusion criteria:
People whose age is high and it is difficult to get information from them
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
2
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University, Semnan branch
Street address
Semnan, university campus, Islamic Azad University, Semnan branch
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.IAU.SEMNAN.REC.1402.012
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cognitive flexibility
Timepoint
Before starting the therapeutic intervention on the first day - after completing the therapeutic intervention on the 40th day
Method of measurement
Dennis and Vanderwaal's Cognitive Flexibility Questionnaire (2010)
2
Description
Rumination
Timepoint
Before starting the therapeutic intervention on the first day - after
Method of measurement
Nolen Hoeksma and Maro rumination questionnaire (1991)
3
Description
Mindfulness
Timepoint
Before starting the therapeutic intervention on the first day - after
Method of measurement
Bauer et al.'s five-factor mindfulness questionnaire (2006)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group is subjected to cognitive-behavioral therapy intervention in the treatment center. The treatment is done in 13 sessions. The contents of the treatment sessions in brief are: introducing cognitive behavioral therapy for the participants, assigning tasks according to the training and intervention carried out in each session, reviewing and checking the tasks of the previous sessions at the beginning of each session, teaching the connection between spontaneous thoughts and the feelings of the patient and the group. classifying distorted spontaneous thoughts into them, presenting a cognitive-behavioral model for cognitive distortion and rumination, challenging negative spontaneous thoughts and identifying assumptions and challenging them and applying cognitive techniques to challenge negative spontaneous thoughts, identifying Dysfunctional schemas, examining the origin of schemas and how it affects important life events, mindfulness skill training and mindfulness barriers and mindfulness program solutions for it, defining cognitive flexibility for participants and discussing the individual's ability to adapt and changing demands and responding appropriately to new experiences, helping the patient to review past episodes of depression, and providing strategies to prevent future depression. The duration of each session is 45 minutes and the duration of the course is 40 days.
Category
Treatment - Other
2
Description
Control group: The control group does not receive any intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Meaning and Aram Counseling Center in Karaj
Full name of responsible person
Masoumeh Sadeghi
Street address
No. 50, Unit 17Tehranpars, between 3rd and 4th floors, East 220 St., between Khairi and Mozafari
City
Tehran
Province
Tehran
Postal code
1655767799
Phone
+98 21 7704 0640
Email
sadeghi2002@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Sadeghi
Street address
No. 50, Unit 17Tehranpars, between 3rd and 4th floors, East 220 St., between Khairi and Mozafari St
City
Tehran
Province
Tehran
Postal code
1655767799
Phone
+98 21 7704 0640
Email
sadeghi2002@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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Sadeghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 50, Unit 2Tehranpars, Between Third and Fourth, 220 East Street, between Khairi and Mozaffari Street
City
Tehran
Province
Tehran
Postal code
1655767799
Phone
+98 21 7704 0640
Email
sadeghi2002@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Sadeghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 50, Unit 2Tehranpars, Between Third and Fourth, 220 East Street, between Khairi and Mozaffari Street
City
Tehran
Province
Tehran
Postal code
1655767799
Phone
+98 21 7704 0640
Email
sadeghi2002@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Sadeghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 50, Unit 17Tehranpars, between 3rd and 4th floors, East 220 St., between Khairi and Mozafari St
City
Tehran
Province
Tehran
Postal code
1655767799
Phone
+98 21 7704 0640
Email
sadeghi2002@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available