Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-02-17
2023-05-16
Brief Summary
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The main questions it aims to answer are:
• Is the intervention viewed as acceptable by female survivors of sexual assault? Acceptability is defined as as how willing participants are to use the materials and their satisfaction with its content.
The secondary question is, are there initial indicators that the intervention is effective? Effectiveness is measured by a reduction in the measure of sexual distress and improvement of sexual satisfaction - specifically confidence and motivation in practising strategies that will improve their experience of sex.
Participants will complete the intervention independently. There will be 4-sessions which involve watching videos, with one session completed weekly. The developed materials aim to to help women understand their difficulties, learn practical strategies and build confidence in returning to sex. The materials are also guided by a piloted group for sexual distress by Bart's National Health Service (NHS) trust Sexual Wellbeing Service. The NHS is the publicly funded healthcare system in England.
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Detailed Description
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Potential participants will complete an online screening questionnaire via Qualtrics. Eligible participants who provide consent will complete the baseline questionnaires such as the Female Sexual Function Index, Female Sexual Distress Scale and State Self Compassion Scale. Afterwards, participants will be randomly allocated to different baseline lengths (5 to 14 days) for Phase A.
Participants complete visual analogue scales daily for the length of Phase A. Following Phase A, participants begin Phase B, completing the intervention weekly for four weeks. Visual analogue scales are completed daily during phase B.
Follow-up occurs four weeks after Phase B. Participants complete the Female Sexual Function Index, Female Sexual Distress Scale, State Self Compassion Scale, Client Satisfaction Questionnaire and a qualitative feedback form.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Online guided self-help intervention for sexual distress following sexual assault
The intervention only has one arm. All participants will be provided 4 sessions of guided self-help intervention to be completed once weekly.
Online guided self-help intervention for sexual distress following sexual assault
4 Sessions of guided self-help will be shared with the participants. These will be in the form of handout and video recordings that participant access through Qualtrics. The intervention is based on research on sexual trauma, psychosexual difficulties and materials developed by Bart's NHS Foundation Trust Sexual Wellbeing Service. It has been made in collaboration with clinicians within the service, experts by experience and the chief investigator.Within the document there are scripts for each session which are read out in the video recordings. The handouts depict the visual images for the video and the materials provided to participant.
Interventions
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Online guided self-help intervention for sexual distress following sexual assault
4 Sessions of guided self-help will be shared with the participants. These will be in the form of handout and video recordings that participant access through Qualtrics. The intervention is based on research on sexual trauma, psychosexual difficulties and materials developed by Bart's NHS Foundation Trust Sexual Wellbeing Service. It has been made in collaboration with clinicians within the service, experts by experience and the chief investigator.Within the document there are scripts for each session which are read out in the video recordings. The handouts depict the visual images for the video and the materials provided to participant.
Eligibility Criteria
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Inclusion Criteria
* Experience of sexual assault (in adulthood or childhood but not within the previous 12 months)
* Experiencing sexual distress/difficulties
* United Kingdom Resident
* Willingness to complete guided self help
* Aged 18 and above
* Ability to read and understand English to provide informed consent and meaningfully engage with the self-help materials
* Ability to access online guided self-help material through a computer or phone
Exclusion Criteria
* sexual assault occurring within the last 12 months
* currently experiencing more than fleeting suicidal thoughts or engaging in severe self-harming (individuals who have been sexually assaulted are likely to experience suicidal thoughts or self harm behaviours, individuals with fleeting suicidal thoughts or superficial self harm with strong protective factors may be included however, since there is no contact with mental health professionals during the intervention unless participants reach out for triage, it is difficult to assess risk and participants have to be excluded if they do not have social support systems of are currently accessing psychological support).
18 Years
FEMALE
Yes
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
Royal Holloway University
OTHER
Responsible Party
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Kimberley Khoo
Principal Investigator, Trainee Clinical Psychologist
Principal Investigators
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Jane Vosper
Role: PRINCIPAL_INVESTIGATOR
Bart's NHS Foundation Trust
Locations
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Bart's Sexual Wellbeing Service, National Health Service
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: research protocol
Document Type: Study Protocol: intervention manual
Other Identifiers
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3379
Identifier Type: -
Identifier Source: org_study_id
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