Protocol summary
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Study aim
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This study aimed to determine the effect of expressive writing on anxiety, depression and quality of life in women with Human Papillomavirus infection.
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Design
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Randomized clinical trial, single-blind with parallel groups, including: one intervention group and one control group (72 participants in each group). Sampling will be simple random sampling. The allocation of individuals to the two groups will be done using the randomization website.
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Settings and conduct
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At baseline, all participants in both the intervention and control groups will complete the demographic questionnaire, Beck Anxiety Inventory (BAI), Beck Depression Inventory-II (BDI-II), and the WHO Quality of Life questionnaire (WHOQOL-BREF).
Following a 4-week intervention period, participants in both groups will complete the same questionnaires again to assess changes.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age between 18 and 45 years old, Iranian nationality, diagnosis of Human Papillomavirus (HPV) infection.
Exclusion criteria: presence of malignant and known diseases,
concurrent sexually transmitted infections, presence of Cervical Intraepithelial Neoplasia Grade 3 (CIN3), consumption of alcohol and drugs, presence of known mental disorders (based on self-report of the participant), occurrence of a stressful event at least 2 months prior.
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Intervention groups
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The intervention group will be introduced to the intervention implementation method and written expression technique in a training session. Writing should be done using free association without deliberate thought, followed by 30 minutes of writing about their emotions and feelings without concern for spelling or grammar. Control group will be asked to write about their daily activities, once a week for four consecutive weeks, dedicating 30 minutes each session.
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Main outcome variables
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Depression, anxiety, quality of life.
General information
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Reason for update
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According to the beginning of the war, sampling time, sampling location, and sampling type were changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090810002324N22
Registration date:
2025-08-10, 1404/05/19
Registration timing:
prospective
Last update:
2026-06-20, 1405/03/30
Update count:
1
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Registration date
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2025-08-10, 1404/05/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2026-06-10, 1405/03/20
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Expected recruitment end date
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2026-09-11, 1405/06/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of expressive writing on anxiety, depression and quality of life in women with Human Papillomavirus Infection
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Public title
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Expressive writing, anxiety, depression and quality of life in women with Human Papillomavirus infection
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age Between 18 and 45 years old
Iranian Nationality
Ability to read and write
Definite diagnosis of Human Papilloma virus (HPV), at least 3 months prior (confirmed by HPV test or diagnosis of genital warts ), documented in the patient's file.
Exclusion criteria:
Presence of malignant diseases
Concurrent sexually transmitted infections
Presence of Cervical Intraepithelial Neoplasia Grade 3 (CIN3)
Pregnancy
Breastfeeding
Presence of known mental disorders (based on self-report of the participant)
Consumption of alcohol and drugs
Contact with other individuals with HPV infection attending the clinic or membership in shared online groups
Occurrence of a stressful event at least 2 months prior
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
144
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Initially, the clinic manager will provide the researcher with the contact numbers of individuals who meet the inclusion criteria. The list of names will be randomly divided into two groups: experimental and control. The allocation of individuals to the two groups will be done using the randomization website (www.randomizer.org).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants and the researcher will be aware of how individuals are assigned to each of the two intervention and control groups. Before and after intervention, in order to blinding, all questionnaires will be presented and collected by a research assistant who is unaware of the allocation method and project objectives. Therefore this study is single-blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-06-29, 1404/04/08
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Ethics committee reference number
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IR.IUMS.REC.1404.351
Health conditions studied
1
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Description of health condition studied
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Human Papillomavirus Infection
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ICD-10 code
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A63.8
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ICD-10 code description
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Other specified predominantly sexually transmitted diseases
Primary outcomes
1
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Description
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The mean score and severity of depression
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Timepoint
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before the intervention and Immediately after the completion of the intervention.
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Method of measurement
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The Beck Depression Inventory II(BDI-II)
2
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Description
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The mean score and severity of anxiety
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Timepoint
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Before the intervention and Immediately after the completion of the intervention
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Method of measurement
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The Beck Anxiety Inventory (BAI)
3
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Description
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The mean score of quality of life
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Timepoint
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before the intervention and Immediately after the completion of the intervention
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Method of measurement
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The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Intervention groups
1
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Description
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Intervention group: The intervention group will practice the expressive writing technique once a week for four consecutive weeks, dedicating 30 minutes each session. Writing should be performed in the morning immediately after waking up, in a quiet environment. Initially, writing should be done using free association without deliberate thought, followed by 30 minutes of writing about their emotions and feelings without concern for spelling or grammar. The expressive writing tasks are as follows:• Day 1: Write about themselves (emotions, characteristics, strengths and weaknesses, goals, and aspirations).• Day 2: Write about their deepest feelings, thoughts, and concerns related to their illness.• Day 3: Write about their most difficult experience related to human papillomavirus (HPV).• Day 4: Write about positive thoughts and expectations regarding the treatment process related to HPV.
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Category
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Prevention
2
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Description
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Control group: To ensure consistency between groups participants in the control group will also receive an intervention. They will be asked to write about their daily activitiesو once a week for four consecutive weeks, dedicating 30 minutes each session.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable