Comparison of the effectiveness of cognitive-behavioral therapy and motivational interviewing on the symptoms of anxiety sensitivity, depression and self-esteem in divorced women covered by comprehensive health service centers in Khomein city.
Comparison of the effectiveness of cognitive-behavioral therapy and motivational interviewing on the symptoms of anxiety sensitivity, depression and self-esteem in divorced women covered by comprehensive health service centers in Khomein city.
Design
This study includes an experimental group (cognitive-behavioral therapy) and a comparison group (motivational interview) of the control and follow-up group.
And random assignment of 20 participants to each group and implementation of interventions (two experimental groups and one control group).
Settings and conduct
Divorced women in the age group of 20-50 years with health records in all comprehensive urban and rural service centers in the form of group sessions of experimental groups undergo cognitive-behavioral therapy interventions and motivational interviews and the control group does not receive any intervention. The results are analyzed using multivariate analysis of covariance.
Participants/Inclusion and exclusion criteria
Divorced women with depression, low self-esteem and anxiety sensitivity
Intervention groups
This research is a quasi-experimental design with pre-test-post-test in experimental group (cognitive behavioral therapy), comparison group (motivational interview) and control and follow-up group (without intervention).
Beck, (1986), Reese & Peterson (1985) Anxiety Sensitivity Questionnaire
Main outcome variables
The self-esteem variable is assessed by the Rosenberg Self-Esteem Questionnaire (1965), the Depression variable is assessed by the Aaron Beck Depression Inventory (1986), and the Anxiety Sensitivity variable is assessed by the Reese and Peterson Anxiety Sensitivity Questionnaire (1985).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220328054360N1
Registration date:2022-04-18, 1401/01/29
Registration timing:prospective
Last update:2022-04-18, 1401/01/29
Update count:0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Abbas Bayatasghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4622 3613
Email address
abolfazl86khomein@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of cognitive-behavioral therapy and motivational interviewing on the symptoms of anxiety sensitivity, depression and self-esteem in divorced women covered by comprehensive health service centers in Khomein city.
Public title
Comparison of the effectiveness of cognitive-behavioral therapy and motivational interviewing on the symptoms of anxiety sensitivity, depression and self-esteem in divorced women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The borderline score in the Rosenberg Self-Esteem Questionnaire is 10 questions, 30 and below
The borderline score in the Anxiety Sensitivity Questionnaire is 25 and higher
The borderline score in the Anxiety Sensitivity Questionnaire is 25
Absence of psychotic and paranoid disorders in the subjects
Receiving voluntary and informed consent
At least 6 months have passed since their divorce
Age gap between 20 to 50 years
Have at least a diploma
Exclusion criteria:
Absence for more than two sessions
Lack of interest of people to continue education
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample includes 60 divorced women (20 to 50 years old) who have the criteria to enter the intervention and are selected by systematic random sampling and Then there is a random assignment of 20 participants to each group and the implementation of interventions.
Randomly (table of random numbers) are divided into three experimental groups (two experimental groups) and a control group (20 people in each group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University - Kerman Branch
Street address
Kerman, Valiasr Blvd., Islamic Azad University, Kerman Branch
City
Kerman
Province
Kerman
Postal code
7635168111
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.IAU.KERMAN.REC.1400.027
Health conditions studied
1
Description of health condition studied
Depressive disorder
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
2
Description of health condition studied
anxiety sensitivity
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
The primary outcome is the "Depression Score in the Beck Questionnaire".For this purpose, achieving the differential rate of depression between the two depressed and healthy groups, number 17, is determined, which is the appropriate number of differentiation between this group.
Timepoint
Experimental groups undergo motivational interview therapy for 5 sessions of 75 minutes and cognitive-behavioral therapy for 12 sessions of 75 minutes from May 1401, one session per week until the end of July.
Method of measurement
The research instrument is Aaron Beck, Beckward, Mendelson, Mark and Arbaf (1986) Depression Scale Questionnaire
2
Description
The primary outcome is the anxiety sensitivity score obtained in the Anxiety Sensitivity Questionnaire. In this questionnaire, the highest score that a person can get is 80 and the lowest score is 16. A high score close to 80 will mean that the person has a high anxiety sensitivity, and a low score on this test will mean that the person is experiencing a low anxiety sensitivity. The borderline score is 25 or higher.
Timepoint
Experimental groups undergo motivational interview therapy for 5 sessions of 75 minutes and cognitive-behavioral therapy for 12 sessions of 75 minutes from May 1401, one session per week until the end of July.
Method of measurement
Research tool Anxiety Sensitivity Questionnaire: is a self-report questionnaire that has 16 items. This questionnaire was developed by Reese and Patterson (1985)
3
Description
The primary outcome is the self-esteem score obtained on the Rosenberg Self-Esteem Questionnaire. This scale contains 10 general terms that measure life satisfaction and feeling good about oneself.
Timepoint
Experimental groups undergo motivational interview therapy for 5 sessions of 75 minutes and cognitive-behavioral therapy for 12 sessions of 75 minutes from May 1401, one session per week until the end of July.
Method of measurement
The research tool is the Rosenberg Self-Esteem Scale Questionnaire, which consists of 10 items that are answered based on the Likert scale of four degrees from strongly agree to strongly disagree.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive-behavioral therapy: A type of psychotherapy that helps patients understand the thoughts and feelings that affect behaviors. Cognitive-behavioral therapy is based on the book of applied cognitive-behavioral group therapy written by Najmeh Hamid and consists of 12 sessions of 75 minutes. The experimental group undergoes cognitive-behavioral therapy interventions. , Mendelssohn, Mark and Arbaf (1986), and the results are analyzed using multivariate analysis of covariance.
Category
Treatment - Other
2
Description
Intervention group: Motivational interviewing is a patient-centered method that uses to examine and resolve ambiguities in order to increase people's inner motivation to change behavior. Motivational interviewing is based on the practical guide of group motivational interviewing written by Dr. Ali Navidian and Dr. Hamid Poursharifi in 5 sessions of 75 minutes The research tool is the Rosenberg Self-Esteem Questionnaire (1965) and the results are analyzed using multivariate analysis of covariance.
Category
Treatment - Other
3
Description
Control group: In this study, except for CBT therapeutic interventions for the experimental group and motivational interview therapeutic intervention for the comparison group, no other intervention is performed. In addition, for the control group (control) only the mentioned questionnaires (depression, self-esteem, anxiety sensitivity) are distributed and collected as pre-test and post-test. In the control group, no intervention is performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Urban and rural health service centers affiliated to Khomein School of Medicine
Full name of responsible person
Abbas Bayatasghari
Street address
Health Deputy, Quds Boulevard, Khomein
City
khomein
Province
Markazi
Postal code
3881858591
Phone
+98 86 4622 9327
Email
abolfazl86khomein@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khomein School of Medical Sciences
Full name of responsible person
Hamid momeni
Street address
Markazi Province - Khomein County - Quds Boulevard -Deputy of Education and Research
City
Khomein
Province
Markazi
Postal code
3881858591
Phone
+98 86 4622 1534
Email
abolfazl86khomein@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
khomein Medical Sciences and Health Services
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
Khomein School of Medical ScieKhomein School of Medical Sciencesnces
Full name of responsible person
Abbas Bayatasghari
Position
Disease control expert of the health deputy
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
Markazi Province - Khomein County - Quds Boulevard - Deputy Minister of Health
City
khomein
Province
Markazi
Postal code
3881858591
Phone
+98 86 4622 9237
Email
abolfazl86khomein@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khomein School of Medical Sciences
Full name of responsible person
Abbas Bayatasghari
Position
Disease control expert of Khomeini Health Department
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
Markazi Province - Khomein County - Quds Boulevard - Deputy Minister of Health
City
khomein
Province
Markazi
Postal code
3881858591
Phone
+98 86 4622 9327
Email
abolfazl86khomein@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khomein Deputy Minister of Health
Full name of responsible person
Abbas Baaytasghari
Position
Disease control expert of Khomeini Health Department
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
Markazi province - Khomein city - Ghods boulevard - Khomein health deputy
City
Khomein
Province
Markazi
Postal code
3881858591
Phone
+98 86 4622 9327
Email
abolfazl86khomein@yahoo.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
Only part of the data such as the original outcome information
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
For researchers working in academic and scientific institutions as well as applications in other industries
Under which criteria data/document could be used
Use of documents and other data analysis only by observing the principles formulated in scientific and ethical laws
From where data/document is obtainable
Email address or website
What processes are involved for a request to access data/document
Request and request documents or files through this site and email address