Comparison of the Effect of Counseling Based on the Acceptance and Commitment Model versus the Self-Compassion Model on Quality of Life and Sexual Satisfaction in Women with Human Papillomavirus (HPV)
Determine and compare the effect of counseling based on the Acceptance and Commitment model versus the Self-Compassion model on the quality of life and sexual satisfaction of women with HPV.
Design
The sample size, accounting for attrition, will be 60 participants. The random allocation process consists of two steps:
Generating a random allocation to the two intervention groups using Random Allocation software.
Concealment: The sequence will be implemented in such a way that the interventions remain concealed until participants are officially assigned to the research groups.
blinding of participants and intervention providers will not be possible.
Settings and conduct
This study is a randomized controlled trial with a pretest, post test, and follow-up design. The research setting is the Baghaipour Specialized and Subspecialized Women's Clinic in Yazd city.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Positive HPV test؛ Less than 12 months have passed since the positive test result؛Willingness to participate in the study and complete the informed consent form؛No diagnosis of another type of sexually transmitted infection (STI)؛Sexually active (self-reported)
Exclusion Criteria: Development of HPV-related cancer during the study؛ Absence from more than 30% of sessions (more than two sessions missed)؛ Having a neurological or psychiatric disorder (self-reported)
Intervention groups
Women in the Acceptance and Commitment Therapy (ACT) intervention group will receive their intervention in a group format, both in-person and online, over six 90-minute sessions. The Self-Compassion intervention group will also receive their intervention in a group format, both in-person and online, over six 90-minute sessions.
Main outcome variables
Quality of Life - Sexual Satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260508069291N1
Registration date:2026-05-15, 1405/02/25
Registration timing:prospective
Last update:2026-05-15, 1405/02/25
Update count:0
Registration date
2026-05-15, 1405/02/25
Registrant information
Name
Azam Zare arashlouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3272 1207
Email address
a.zarearashlouei@stu.ssu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-23, 1405/03/02
Expected recruitment end date
2027-05-23, 1406/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Counseling Based on the Acceptance and Commitment Model versus the Self-Compassion Model on Quality of Life and Sexual Satisfaction in Women with Human Papillomavirus (HPV)
Public title
Comparison of the Effect of Counseling Based on the Acceptance and Commitment Model versus the Self-Compassion Model on Quality of Life and Sexual Satisfaction in Women with Human Papillomavirus (HPV)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1.Positive HPV test 2.Less than 12 months have passed since the positive test result 3.Willingness to participate in the study and complete the informed consent form 4.No diagnosis of another type of sexually transmitted infection (STI) 5.Sexually active (self-reported)
Exclusion criteria:
1.Development of HPV-related cancer during the study 2.Absence from more than 30% of sessions (more than two sessions missed) 3.Having a neurological or psychiatric disorder (self-reported)
Age
From 15 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
Research participants will be divided into two intervention groups using random allocation: group counseling based on the Acceptance and Commitment model (n = 30) and group counseling based on the Self-Compassion model (n = 30). The random allocation process consists of two steps:
1. Generating a random allocation to the two intervention groups using Random Allocation software.
2.Concealment: The sequence will be implemented in such a way that the interventions remain concealed until participants are officially assigned to the research groups.
Due to the nature of the topic, objectives, and hypotheses of the study, blinding of participants and intervention facilitators will not be possible
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
Timsar Falahi Street, Boali Alley
City
Yazd
Province
Yazd
Postal code
8915818411
Approval date
2026-05-05, 1405/02/15
Ethics committee reference number
IR.SSU.REC.1405.020
Health conditions studied
1
Description of health condition studied
Human Papillomavirus (HPV)
ICD-10 code
R87.811
ICD-10 code description
Vaginal high risk human papillomavirus (HPV) DNA test positive
Primary outcomes
1
Description
Quality of life and sexual satisfaction based on a questionnaire
Timepoint
Before the start of the intervention, immediately after the intervention, and 8 weeks after the completion of the intervention
Method of measurement
Quality of Life and Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1 (Acceptance and Commitment Therapy model) (30 participants) will receive their intervention in the form of six 90-minute sessions of group counseling based on the Acceptance and Commitment Therapy model. At the beginning of the first intervention session, the Quality of Life and Sexual Satisfaction Questionnaire will be completed by the participants. The sessions will be conducted in a hybrid format (online and in-person) as a pre-test, post-test, and follow-up period. At the end of the sessions and 8 weeks after the completion of the intervention, the variables of quality of life and sexual satisfaction will be reassessed using the relevant questionnaire.
Category
Other
2
Description
Intervention group: Group 2 (Self-Compassion model) (30 participants) will receive their intervention in the form of six 90-minute sessions of group counseling based on the Self-Compassion model. At the beginning of the first intervention session, the Quality of Life and Sexual Satisfaction Questionnaire will be completed by the participants. The sessions will be conducted in a hybrid format (online and in-person) as a pre-test, post-test, and follow-up period. At the end of the sessions and 8 weeks after the completion of the intervention, the variables of quality of life and sexual satisfaction will be reassessed using the relevant questionnaire.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized and sub-specialized women's clinic in Baghaeipour, Yazd
Full name of responsible person
Leila Asadi
Street address
Timsar Falahi Street, Bo Ali Alley
City
Yazd
Province
Yazd
Postal code
8915818411
Phone
+98 913 395 7856
Email
dr.leilaasadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Timsar Falahi Street, Bo Ali Alley
City
Yazd
Province
Yazd
Postal code
8915818411
Phone
+98 913 495 7077
Email
zare.arashlouei.azam@gmail.com
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
Yazd University of Medical Sciences
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Timsar Falahi Street, Bo Ali Alley
City
Yazd
Province
Yazd
Postal code
8915818411
Phone
+98 35 3824 1751
Email
dr.leilaasadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Leila Asadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Timsar Falahi Street, Bo Ali Alley
City
Yazd
Province
Yazd
Postal code
8915818411
Phone
+98 35 3824 1751
Email
dr.leilaasadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azam Zare arashlouei
Position
Ph.D Student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Kerman, Jihad Street, Alley 61
City
Kerman
Province
Kerman
Postal code
7619865695
Phone
0342721207
Email
zare.arashlouei.azam@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