Effectiveness of Group Counseling with Acceptance and Commitment Therapy(ACT) on the Degree Sexual Satisfaction of HIV Positive Women and with HIV Positive Husband
Determine the effect of group counseling with Acceptance and Commitment Therapy (ACT) on the degree sexual satisfaction of HIV positive women and women with HIV positive husband
Design
Clinical trials with community based and pragmatic control group, with parallel groups, Not blinded, randomized
Settings and conduct
This research is a semi-experimental study type (RCT) with parallel study and control group. The statistical population of this study was purposeful sampling and included all HIV positive women and with HIV-infected wife, referred to the Behavioral Counseling Center in Yazd and Meybod. According to similar studies, the sample size is 32, and individuals qualifying for entry criteria are selected. After obtaining written consent, the participants are randomly assigned to two groups of study and control, and complete the Larson sexual satisfaction questionnaires. The test group then participates in ACT sessions. But the control group does not receive treatment. After the end of treatment sessions, one month afterwards, the post-test is performed from both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
. Having Iranian citizenship
• The participant or his / her spouse has HIV
• Spend at least one year of living together
• Permanent monogamy living together
Exclusion criteria:
. Not willing to cooperate in research
. Acute and debilitating mental illness in yourself and your spouse
• Having a sexual dysfunction in yourself and your spouse
Intervention groups
The intervention group participates in admission and commitment treatment sessions in 10 sessions of 90 minutes in group and weekly sessions based on the ACT treatment plan; the intervention group does not receive the intervention.
Main outcome variables
Sexual Satisfaction Score
General information
Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number:IRCT20181213041956N1
Registration date:2019-10-14, 1398/07/22
Registration timing:retrospective
Last update:2019-10-14, 1398/07/22
Update count:0
Registration date
2019-10-14, 1398/07/22
Registrant information
Name
Nairsadat Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 5508
Email address
n.taheri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-12-09, 1397/09/18
Actual recruitment end date
2019-02-12, 1397/11/23
Trial completion date
2019-03-16, 1397/12/25
Scientific title
Effectiveness of Group Counseling with Acceptance and Commitment Therapy(ACT) on the Degree Sexual Satisfaction of HIV Positive Women and with HIV Positive Husband
Public title
Effect of ACT on the Sexual Satisfaction Women Involved with HIV
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least one year of common life history
The participant or his wife is HIV-positive
Iranian citizenship
The common life of permanent monogamy
Exclusion criteria:
Not willing to cooperate in research
Acute and debilitating mental illness in yourself and your spouse
Having a sexual dysfunction in yourself and your spouse
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization method by random number table
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
End of Yas, Hariri Alley, Motahari Ave.
City
Yazd
Province
Yazd
Postal code
8917698148
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.SSU.REC.1397.110
Health conditions studied
1
Description of health condition studied
Sexual satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual Satisfaction Score
Timepoint
Measurement of sexual satisfaction score before, after and one month after the completion of counseling
Method of measurement
Larson Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, routine care and 10 sessions of 90 minutes group counseling with acceptance and commitment approach were held once a week.
Category
Behavior
2
Description
Control group: received only routine care at the center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Counseling Centers for Behavioral Illnesses in Yazd
Full name of responsible person
Naiersadat Taheri
Street address
Imam Jafar Sadegh Blvd, Imam Jafar Sadeq Alley
City
Yazd
Province
Yazd
Postal code
8916715171
Phone
+98 35 3624 1444
Fax
+98 35 3624 1444
Email
taherynaier@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Counseling Centers for Behavioral Illnesses in Maybod
Full name of responsible person
Nairsadat Taheri
Street address
Counseling Center for Behavioral Illnesses, Bfrooyeh, Meybod.
City
Maybod
Province
Yazd
Postal code
8963113131
Phone
+98 35 3234 3007
Email
seyedrohollah@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
Faculty of Midwifery Nursing، Bu'ali Alley،Timsar Fallahi Avenue، Safaiyeh،Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1751
Fax
Email
taherynaier@yahoo.com
Web page address
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
Nairsadat Taheri
Position
Master's degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Midwifery and Nursing, Bouali Sina Alley, Timsar Fallahi St., Safaiyeh.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1751
Email
taherynaier@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Midwifery and Nursing, Bouali Sina Alley, Timsar Fallahi St., Safaiyeh.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nairsadat Taheri
Position
Master's degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Midwifery Nursing، Bu'ali Alley،Timsar Fallahi Avenue، Safaiyeh،Yazd
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1751
Email
taherynaier@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The results of the clinical study will be published as a article
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
all researchers
Under which criteria data/document could be used
Scientific use with reference to article
From where data/document is obtainable
Naiersadat Tahery, taherynaier@yahoo.com
What processes are involved for a request to access data/document