The Comparison of Cognitive Behavioral Therapy (CBT) vs Drug Bupropion Therapy on Anxiety of Sexual Relationship and Marital Conflict
Design
45 patients were selected randomly among those referring to treatment centers, then 15 of them were trained cognitive-behavioral therapy and 15 subjects were treated with bupropion and 15 got no intervention as controls.
Settings and conduct
The research was a semi-experimental one which was divided into three groups based on pre-test post-test design. The statistical population of the study included people who referred to midwifery offices and psychiatric clinics in Neyshabur with a sexual anxiety complaint and were assigned to three groups (cognitive-behavioral therapy, pharmacotherapy, and control group). The first group received 8 treatments for cognitive behavioral therapy and the second group received medication, during which time the control group received no psychological or medication intervention. All three groups were evaluated at the beginning and at the end of the research by questionnaires.
Participants/Inclusion and exclusion criteria
married
Age range 20 to 45 years old and have sex anxiety
Intervention groups
The first group: cognitive-behavioral therapy, the second group: medication, the third group: control group who received no treatment
Main outcome variables
Decreased sex anxiety after receiving psychological and pharmaceutical treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190122042461N1
Registration date:2019-02-27, 1397/12/08
Registration timing:retrospective
Last update:2019-02-27, 1397/12/08
Update count:0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
sara rajabpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4221 0880
Email address
sh.rajabpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Cognitive-Behavioral Therapy (CBT) and Drug Therapy (Bupropion) on Female Sexual Anxiety
Public title
Comparison of the effectiveness of Cognitive-Behavioral Therapy and Drug Therapy (Bupropion) on Sexual Anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
married
aging between 20-45 years
Having anxiety sex
Exclusion criteria:
Single
Age less than 20 years and more than 45 years
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
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.research.ac.ir
Street address
NO.1299,Mikhak Ave,Emam ,Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
۹۳۷۱۹۳۷
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1397.014
Health conditions studied
1
Description of health condition studied
Sexual Anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
score of Anxiety Inventory Sex
Timepoint
Measuring sexual anxiety before and after cognitive behavioral and drug therapy
Method of measurement
Sexual Anxiety Scale
Secondary outcomes
1
Description
Marital conflict testing
Timepoint
Sexual anxiety and marital conflict before and after intervention in a 30-day period
Method of measurement
Use of Marital Conflict Questionnaire
Intervention groups
1
Description
First intervention group: Cognitive-behavioral therapy education. Cognitive-behavioral learning changes people's thinking and communication as their own.This kind of training includes: Encountering anxieties and stimuli.So, people can make up their anxious feelings in any situation by creating new associations.Also, based on this kind of education, people are rebuilding their inefficient knowledge.Also, based on this type of training, people are rebuilding their inefficient knowledge. This training takes place in 8 sessions of 45 minutes, which is held weekly
Category
Treatment - Other
2
Description
Second intervention group: Bupropion 75 mg daily, for 8 weeks, Velban product
Category
Treatment - Other
3
Description
Control group: control group, who did not receive any treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's clinics and psychiatric clinics
Full name of responsible person
Sara Rajabpour
Street address
N.1299,Mikhak Ave ,EmamBlvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
۹۳۱۱۳۹۳۱
Phone
+98 51 4221 0880
Email
sh.rajabpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Rajabpour
Street address
No:1299, Mikhak Ave, Emam Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
۹۳۷۱۹۳۷
Phone
+98 51 4221 0880
Email
sh.rajabpour@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
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
Sara Rajabpour
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1299, Ave Mikhak, Emam Blvd
City
Neyshabor
Province
Razavi Khorasan
Postal code
۹۳۷۱۹۳۷
Phone
+98 51 4221 0880
Email
sh.rajabpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Rajabpour
Position
Psychology Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.1299, Mikhak Ave,Emam Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
۹۳۷۱۹۳۷
Phone
+98 51 4221 0880
Email
sh.rajabpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Rajabpour
Position
Phd student of Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
NO.1299,Mkhak Ave,Emam Blvd
City
Neyshabur
Province
Razavi Khorasan
Postal code
۹۳۷۱۹۳۷
Phone
+98 51 4221 0880
Email
sh.rajabpour@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
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 part of the data is shared (data about the result of the data)
When the data will become available and for how long
Starting the access period from 2020
To whom data/document is available
Academic Researchers and Student
Under which criteria data/document could be used
Only to investigate female sexual anxiety
From where data/document is obtainable
Neyshabur، N:1299، Ave Mikhak، Blvd Emam
What processes are involved for a request to access data/document
Sexual Anxiety, Bupropion, Marital Conflict, Cognitive Behavioral Therapy.