Determining the effect of acceptance and commitment therapy on the sexual quality of life in women infected with human papillomavirus
Design
A randomized controlled clinical trial with intervention and control groups, including 48 participants
Settings and conduct
This research is a Randomized Controlled Trial (RCT). The study population consists of women with HPV attending the Ayatollah Mousavi Center in Zanjan. Participants will first be selected using convenience sampling and then allocated to two groups, intervention and control, via block randomization.
Participants/Inclusion and exclusion criteria
Inclusion: Minimum literacy; married women aged 18-45, sexually active, HPV positive, married ≥ 6 months, and poor/moderate SQOL-F score.
Exclusion: Occurrence of stressful life events within the past 6 months, history of psychological disorders or underlying medical conditions, substance and alcohol addiction
Intervention groups
Participants in the intervention group will receive Acceptance and Commitment Therapy (ACT) in eight weekly 90‑minute group sessions conducted by a trained researcher. Sessions include ACT principles, mindfulness, acceptance of negative emotions, reduction of experiential avoidance, identification of personal values, and committed action to improve sexual functioning. Questionnaires will be completed post‑intervention and one month later (telephone follow‑up).
The control group will receive routine care only and complete questionnaires at the same time points. After the study, an educational booklet and optional training session will be provided for ethical considerations.
Main outcome variables
Quality of Sexual Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201113049377N4
Registration date:2026-03-19, 1404/12/28
Registration timing:prospective
Last update:2026-03-19, 1404/12/28
Update count:0
Registration date
2026-03-19, 1404/12/28
Registrant information
Name
Parvin Mohebbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 6258
Email address
p.mohebbi11@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-04-03, 1405/01/14
Expected recruitment end date
2027-03-16, 1405/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acceptance and Commitment Therapy (ACT) on the Sexual Quality of Life in Women Infected with Human Papillomavirus (HPV)
Public title
The Effect of Counseling on the Sexual Quality of Life of Women with Human Papillomavirus Infection
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write (minimum literacy level)
Women aged 18–45 years (to reduce the potential impact of age-related changes on sexual function).
Women who are married and sexually active
Laboratory-confirmed positive test for Human Papillomavirus (HPV)
At least six months since the initiation of marital life
Poor to moderate sexual quality of life based on the Sexual Quality of Life–Female (SQOL-F) questionnaire
Exclusion criteria:
Occurrence of stressful life events within the past 6 months
History of psychological disorders or underlying medical conditions
Substance or alcohol abuse
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
After providing a comprehensive explanation of the study objectives and procedures to eligible clients, women who meet the inclusion criteria will be identified. Subsequently, the demographic information questionnaire and the Sexual Quality of Life questionnaire will be administered for completion.
Eligible participants will be recruited during their routine and consecutive visits to the gynecology clinic. They will then be randomly allocated into intervention and control groups using block randomization method (block size: four). For this purpose, 12 blocks of four participants each will be generated using a table of random numbers, resulting in a total sample size of 48 participants. The block randomization process will be carried out by an individual who is not involved in the sampling or intervention procedures to minimize allocation bias.
The generated random sequences will be recorded on individual cards and placed sequentially into sealed envelopes. After sealing, the envelopes will be stored in a box. At the initiation of the intervention, envelopes will be opened sequentially, and the participant’s group assignment will be determined accordingly.
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 Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Professor Dr. Yousef Sobhouti Boulevard, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2026-02-03, 1404/11/14
Ethics committee reference number
IR.ZUMS.REC.1404.361
Health conditions studied
1
Description of health condition studied
Women Infected with Human Papillomavirus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of Sexual Life
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Sexual Quality of Life–Female Questionnaire (SQOL‑F) by Symonds
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in this group will receive counseling based on Acceptance and Commitment Therapy (ACT). The intervention consists of eight weekly 90‑minute group sessions conducted by a trained researcher. The session content includes introduction to the principles and concepts of the ACT approach, reduction of experiential avoidance, acceptance of negative emotions (such as shame and anxiety), mindfulness exercises, identification of personal values in the domains of health and intimate relationships, and planning for committed actions aimed at improving sexual functioning and sexual experience.
Category
Lifestyle
2
Description
Control group:Participants in this group will not receive any ACT‑based educational or counseling intervention during the study period and will only receive routine care. To observe ethical considerations, after completion of the study an educational booklet containing the session content will be provided to participants in the control group, and if desired, an educational session will be held for them.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Medical Center, Zanjan university of medical sciences,Zanjan
Full name of responsible person
Masud Hoseinlo
Street address
Ayatollah Mousavi Specialized and Subspecialized Teaching and Medical Center, Gavazang Road, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 0872
Email
Mousavihospital@zums.ac.ir
Web page address
https://mousavi.zums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehrdad Hamidi
Street address
First Floor, Building No. 1, Central Headquarters No. 2, Zanjan University of Medical Sciences and Health Services, Beginning of Jomhouri Eslami Street, Azadi Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3342 0651
Email
hamidim@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Instructor_Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery,School of Nursing and Midwifery,Haj Ahmad Mahdavi Blvd,Shahrak Karmandan Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3346 9500
Email
p.mohebbi11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Assistant Professor of Reproductive Health- Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery,School of Nursing and Midwifery,Haj Ahmad Mahdavi Blvd,Shahrak Karmandan Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3346 9500
Email
p.mohebbi11@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mina Bazargan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery,School of Nursing and Midwifery,Haj Ahmad Mahdavi Blvd,Shahrak Karmandan Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3346 9500
Email
fatemehbazargan82@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD