1- Investigating the effect of mindfulness- based cognitive therapy via Whats App social media platform on sexual function and sexual distress in women with diabetes
Design
The clinical trial has a randomized control group, an intervention and a control group of 36 people each, randomization by 4 blocks method.
Settings and conduct
The place of the study is Qazvin comprehensive health centers, the sample of the research is diabetic women referring to the health centers who meet the conditions for entering the study. The participants are randomly assigned to two control and intervention groups. . In the control group, there is no intervention, and in the intervention group, the method of (MBCT) is used. The program will be presented by the researcher as an 8-session program during 8 weeks (the first week in person and the next 7 weeks on WhatsApp platform). Meetings will be held individually. Contents and assignments will be presented to the people of the intervention group on a weekly basis through social media (WhatsApp). The way to follow up the samples in 4 steps is to fill the questionnaire in the first session (pre-test), the last session (post-test), one month after the last session and 3 months after the last training session.
Participants/Inclusion and exclusion criteria
Entry conditions: definitely suffering from diabetes, willing to participate in the study, suffering from sexual dysfunction
Conditions of non-entry: unwillingness to participate in the study, suffering from gestational diabetes and breastfeeding
Intervention groups
Participants are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the method of mindfulness based cognitive therapy (MBCT) is used.
Main outcome variables
sexual function, sexual distress,mindfulness-based Cognitive therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220726055556N1
Registration date:2022-09-03, 1401/06/12
Registration timing:registered_while_recruiting
Last update:2022-09-03, 1401/06/12
Update count:0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
mina fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 5220 8116
Email address
fathimina66@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-12, 1401/05/21
Expected recruitment end date
2022-12-12, 1401/09/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based cognitive therapy via whats app social media on sexual function and sexual distress in women with diabetes
Public title
The effect of mindfulness-based cognitive therapy via whats app social media on sexual function and sexual distress in women with diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
being married
Definite diabetes with a doctor's diagnosis
- Being 15 to 49 years old
Having sexual dysfunction based on the FSFI questionnaire
Access to social media such as internet and smartphone
At least 3 months have passed since having sex with your spouse
Willingness to participate in the study
Exclusion criteria:
Having any symptoms of diseases such as depression, panic attacks, delusions, hallucinations and any other type of mental illness based on the person's self-report.
Unwillingness to continue participating in the study
Taking drugs that affect sexual performance, such as psychotropic drugs
Known physical, mental, sexual disorders in the spouse
Gestational diabetes and breastfeeding diabetes
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
: For random allocation, considering that we have two intervention and control groups, we will use a block of 4. In order to determine the allocation sequence using the 4 block method, random allocation sequence generation software will be used. In order to hide the sequence of allocation, the papers identifying the group of people are placed inside the envelopes in the opaque package and coded in the same order. In this case, a questionnaire with the same code will be completed for the person who receives the code 1 intervention
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
Working group/committee of ethics in research of Qazvin University of Medical Sciences
Street address
Qazvin, North Nawab St., Shahid Salmani Alley, Administration Complex, Headquarters Building of Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
5316848893
Approval date
2022-07-23, 1401/05/01
Ethics committee reference number
IR.QUMS.REC.1401.117
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual performance score in women's sexual performance questionnai
Timepoint
The beginning of the study (pre-test), the end of the study (post-test), 1 month and 3 months after the last session.
Method of measurement
Women's sexual performance index - shortened form
2
Description
Sexual distress score based on revised sexual distress questionnaire
Timepoint
The beginning of the study (pre-test), the end of the study (post-test), 1 month and 3 months after the last session.
Method of measurement
Revised Sexual Distress Questionnaire
3
Description
Mindfulness score based on mindfulness questionnaire
Timepoint
The beginning of the study (pre-test), the end of the study (post-test), 1 month and 3 months after the last session.
Method of measurement
Mindfulness questionnaire (awareness of conscious attention)
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Diabetic women with sexual dysfunction receiving mindfulness-based cognitive therapy . Mindfulness-based cognitive therapy (MBCT) is an approach to psychotherapy that uses cognitive behavioral therapy (CBT) methods along with mindfulness meditation practices and similar psychological strategies. In MBCT, mindfulness is based on 4 principles including Body awareness (body position and body movement/activity), body sensations (including those related to emotions), mental states (including emotional states) and mental content (thoughts, images) are taught. Internet-based cognitive behavioral therapy has recently been introduced as a new method for treating sexual problems. This treatment uses traditional cognitive and behavioral therapy methods to treat sexual problems based on increasing comfort, privacy and anonymity of people. In this study, the participants who meet the study entry criteria are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the method of cognitive therapy based on mindfulness (MBCT) is used. Before starting the treatment program, the training certificate of the MBCT course will be received and attached to the study, then the cognitive therapy program based on mindfulness for sexual function in the form of an 8-session program during 8 weeks (the first week in person and the next 7 weeks on WhatsApp) by The researcher will be presented. Meetings will be held individually. Contents and assignments will be presented to the people of the intervention group on a weekly basis through social media (WhatsApp). After presenting any new content, the researcher will inform the participants by SMS. It will be considered that the participants, whenever they have a problem in doing the assignments, have more interaction with the researcher in person or virtually to ensure the correctness of the assignments. How to follow up the samples in 4 steps by filling out the questionnaire The first session (pre-test), the last session (post-test), one month after the last session and 3 months after the last training session.
Category
Treatment - Other
2
Description
Control group: Diabetic women without receiving cognitive therapy based on mindfulness
Shahid Salmani Alley, Shahid Salmani Alley, Qazvin, Qazvin University of Medical Sciences Headquarters Building, Shahid Bahonar Blvd., University Campus Building
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
Qazvin University of Medical Sciences
Full name of responsible person
Mina Fathi
Position
University student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin, Shahid Bahonar Boulevard, University Campus Building
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
fathimina66@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mina Fathi
Position
University studen
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin, Shahid Bahonar Boulevard, University Campus Building
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
fathimina66@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mina Fathi
Position
University studen
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin, Shahid Bahonar Boulevard, University Campus Building
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 6001
Email
fathimina66@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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available