Effectiveness of Acceptance and Commitment Therapy (ACT) and Relationship Enhancement Couples Therapy (RECT) on intimacy and sexual activity in women with muliple sclerosis
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General information
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Inconsistency of the scientific title of trial in persian and english
Inconsistency of the scientific title of trial in persian and english
empty
عدم تطابق عنوان علمی کارآزمایی در قسمت فارسی و انگلیسی
عدم تطابق عنوان علمی کارآزمایی در قسمت فارسی و انگلیسی
Effectiveness of acceptance and commitment therapy (ACT) and relationship enhancement couples therapy (RECT) on intimacy and sexual activity
Effectiveness of Acceptance and Commitment Therapy (ACT) and Relationship Enhancement Couples Therapy (RECT) on intimacy and sexual activity in women with muliple sclerosis
Effectiveness of acceptanceAcceptance and commitment therapyCommitment Therapy (ACT) and relationship enhancement couples therapyRelationship Enhancement Couples Therapy (RECT) on intimacy and sexual activity in women with muliple sclerosis
Protocol summary
Study aim
Effectiveness comparison of two methods of treatment based on acceptance and commitment therapy (ACT) and relationship enhancement couples therapy (RECT) on intimacy and sexual activity in women with multiple sclerosis in online consulting method
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, on 44 patients, the online random allocation site was used for randomization
Settings and conduct
Female patients who are members of MS Association of Shahid Sadoughi Hospital in Yazd, after being divided into two groups of acceptance and commitment therapy and relationship enhancement couples therapy, completed the questionnaire of intimacy and sexual activity of multiple sclerosis then receive 8 online counseling sessions.
Participants/Inclusion and exclusion criteria
Entry requirements: Relapsing-remitting type of multiple sclerosis based on the diagnosis of the treating physician, Use online consultation with a smart phone and have an Android or iOS smartphone, Being in reproductive age, Shared bed with spouse, Willingness to participate in the study
No entry conditions: Pregnancy, Existence of psychotic disorders and severe mental disorders according to the doctor's diagnosis, Addiction, Existence of domestic violence, Existence of extramarital affair, Existence of emotional divorce according to the research unit
Intervention groups
8 sessions of acceptance and commitment therapy for the intervention group based on online consulting method
8 sessions of relationship enhancement couples therapy for the control group based on online counseling method
Main outcome variables
Intimacy and Sexual activity
General information
Reason for update
Inconsistency of the scientific title of trial in persian and english
Acronym
IRCT registration information
IRCT registration number:IRCT20201226049837N1
Registration date:2021-02-15, 1399/11/27
Registration timing:prospective
Last update:2021-02-27, 1399/12/09
Update count:1
Registration date
2021-02-15, 1399/11/27
Registrant information
Name
fatemeh aliaskari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
f.aliaskarizamani@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-20, 1400/01/31
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Acceptance and Commitment Therapy (ACT) and Relationship Enhancement Couples Therapy (RECT) on intimacy and sexual activity in women with muliple sclerosis
Public title
Effectiveness comparison of two methods of treatment based on acceptance and commitment therapy (ACT) and relationship enhancement couples therapy (RECT) on intimacy and sexual activity in women with multiple sclerosis in online consulting method
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Relapsing-remitting type of multiple sclerosis based on the diagnosis of the treating physician
Use online consultation with a smart phone and have an Android or iOS smartphone
Being in reproductive age
Shared bed with spouse
Willingness to participate in the study
Exclusion criteria:
Pregnancy
Existence of psychotic disorders and severe mental disorders according to the doctor's diagnosis
Addiction
Existence of domestic violence
Existence of extramarital affair
Existence of emotional divorce according to the research unit
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:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size consists of 44 women. Each woman can be assigned a number between 1 and 44, which is done by referring to the online site random allocation.
There are currently three models of random allocation, and since this study is in two groups, the first generation randomization model is used, where each sample is placed in a treatment group and is done through the site.
http://www.randomization.com
This means that the allocation of samples to each of the two groups does not occur in A and B, respectively, but in the order in which the software output is placed.
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 Yazd Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Building No.1, at the beginning of Shahid Sadoughi Boulevard, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-12-21, 1399/10/01
Ethics committee reference number
IR.SSU.REC.1399.203
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Change in the mean scores of intimacy and sexual activity
Timepoint
Beginning of the study, completion of the eighth and twelfth weeks of the study
Method of measurement
Multiple Sclerosis Intimacy and Sexual activity Questionnaire
Secondary outcomes
1
Description
Change in the average scores of satisfaction from counseling
Timepoint
Completion of the eighth and twelfth weeks of the study
Method of measurement
Satisfaction form of counseling
Intervention groups
1
Description
Intervention group: For Acceptance and Commitment Therapy Group participants, 8 session 60-minute weekly group counseling with Acceptance and Commitment Therapy approach are held.
Category
Behavior
2
Description
Control group: For Relationship Enhancement Couples Therapy Group participants, 8 session 60-minute weekly group counseling with Relationship Enhancement Couples Therapy approach are held.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Hossein Soleymani
Street address
Shahid Sadooghi Hospital, Sina Rd, Shahid Ghandi
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 9007
Email
Sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzayi
Street address
Vice Chancellor for Research and Technology, third floor, Shahid Sadoughi University of Medical Sciences, Building No.1, at the beginning of Shahid Sadoughi Boulevard, Bahonar Square
City
Yazd
Province
Yazd
Postal code
816978477
Phone
+98 35 3146 2140
Email
htd@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing And Midwifery, BouAli Rd, Timsar Fallahi St, Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
farajkhoda_t@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing And Midwifery, BouAli Rd, Timsar Fallahi St, Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
farajkhoda_t@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Aliaskarizamani
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing And Midwifery, BouAli Rd, Timsar Fallahi St, Safaeieh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
sahar.askari777@gmail.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