Sexual AssaultNCT05717023
Guided Self-help Following Sexual Assault - SCED
A study testing Online guided self-help intervention for sexual distress following sexual assault in people with Sexual Assault and Sexual Dysfunction, run by Royal Holloway University at 1 site in United Kingdom.
Trial summary
This single-case experimental design aims to evaluate the acceptability \& feasibility of an online guided self-help intervention for female survivors of sexual assault who experience difficulties returning to sex. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault, Sexual Dysfunction, Sex Disorder
- What is being tested?
- Online guided self-help intervention for sexual distress following sexual assault
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2023to 16 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cis female
- 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
Who cannot join
- experiencing severe acute mental health difficulties
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bart's Sexual Wellbeing Service, National Health Service
London
About this study
Official title: Online Guided Self-help Intervention for Sexual Distress Following Sexual Assault: A Single Case Experimental Study
This single-case experimental design aims to evaluate the acceptability \& feasibility of an online guided self-help intervention for female survivors of sexual assault who experience difficulties returning to sex.
The main questions it aims to answer are:
Read more
- 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.
Read the detailed description
The study adopts a non-concurrent AB single-case experimental design (SCED) with follow-up. Although AB designs are not sufficient to test treatment effectiveness, using this study type informs the feasibility of the intervention. In addition, a multiple baseline approach was adopted where participants will be randomly allocated to different lengths of baselines ranging from 5 to 14 days in Phase A. Phase B consists of a 4- week intervention period where participants complete idiographic measures daily. Follow-up will be completed one month after the intervention.
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
- Sexual Assault, Sexual Dysfunction, Sex Disorder
- Being tested
- Online guided self-help intervention for sexual distress following sexual assault
- Keywords
- sexual distress
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online guided self-help intervention for sexual distress following sexual assaultBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online guided self-help intervention for sexual distress following sexual assault | Experimental | The intervention only has one arm. All participants will be provided 4 sessions of guided self-help intervention to be completed once weekly. Receives: Behavioral: Online guided self-help intervention for sexual distress following sexual assault |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire (CSQ)
The client satisfaction questionnaire is an 8-item questionnaire scored on a 4-point scale and will be provided to participants at follow up to ask the acceptability and satisfaction towards the intervention. Permission has been asked to adapt the questionnaire to focus on satisfaction for the intervention instead of service satisfaction. Total scores range from 8 to 32 with higher scores indicating higher satisfaction.
Measured: At follow up, 8 weeks
Feedback Form
A short qualitative feedback form will be provided to participants. This form has been developed with experts by experience and will have open ended questions for participants to provide more detailed feedback about the intervention. The questionnaire is only used at follow up.
Measured: At follow up, 8 weeks
Secondary outcomes (5)
Baseline Visual Analogue Scales
Visual analogue scales are scales with two ends. Participants will be asked to rate on the line how much they agree or disagree with a statement. Visual analogue scales are used to measure the following concepts: shame, guilt, self-criticism, compassion, normalising and motivation. The scales were developed for this research project in collaboration with experts by experience.
Measured: Completed daily up to 2 weeks
Intervention Visual Analogue Scales
Visual analogue scales are scales with two ends. Participants will be asked to rate on the line how much they agree or disagree with a statement. Visual analogue scales are used to measure the following concepts: shame, guilt, self-criticism, compassion, normalising and motivation. The scales were developed for this research project in collaboration with experts by experience.
Measured: Completed daily up to 1 month
Female Sexual Distress scale - Revised (FSDS-R)
The Female Sexual Distress Scale - Revised is used to assess distress related to sex in women. This 13-item self-report questionnaire is scored has five points, (0: never; 1: rarely; 2: occasionally; 3: frequently; 4: always). Total scores range from 0 to 52 with higher scores indicating higher levels of sexual distress.
Measured: Baseline and 8 weeks
Female Sexual Function Index (FSFI)
The Female Sexual Function Index is a 19-item questionnaire that measures six domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The questionnaire uses a 5-point likert scale and is scored from 1 to 5. Total score range from 2 to 36 with lower scores indicating higher levels of difficulties.
Measured: Baseline and 8 weeks
State Self Compassion Questionnaire (SSCS-S)
The State Self Compassion Questionnaire is a 6-item questionnaire scored on a 5-point scale from 1 (not very true for me) to 5 (very true for me). The scale was not develop to indicate high or low levels of state self-compassion rather it is to be used in a comparative manner to examine the change in compassion after the intervention. The minimum score is 1 and the maximum score is 5.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start17 Feb 2023
- Primary completion21 Apr 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single case experimental design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Holloway University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Principal investigator, Kimberley Khoo, Royal Holloway University
- Investigators
- Jane Vosper, Principal investigator, Bart's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717023
- Sponsor's protocol ID
- 3379
- Status last verified
- May 2023
- First submitted
- 17 Jan 2023
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Guided Self-help Intervention for Sexual Distress Following Sexual Assault: A Single Case Experimental Study
- ClinicalTrials.gov ID
- NCT05717023
- Acronym / sponsor ID
- 3379
- Conditions
- Sexual Assault, Sexual Dysfunction, Sex Disorder
- Keywords
- sexual distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Royal Holloway UniversityUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-case experimental design aims to evaluate the acceptability \& feasibility of an online guided self-help intervention for female survivors of sexual assault who experience difficulties returning to sex.
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.
Detailed description
The study adopts a non-concurrent AB single-case experimental design (SCED) with follow-up. Although AB designs are not sufficient to test treatment effectiveness, using this study type informs the feasibility of the intervention. In addition, a multiple baseline approach was adopted where participants will be randomly allocated to different lengths of baselines ranging from 5 to 14 days in Phase A. Phase B consists of a 4- week intervention period where participants complete idiographic measures daily. Follow-up will be completed one month after the intervention.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case experimental design
| Arm | Type | Receives |
|---|---|---|
| Online guided self-help intervention for sexual distress following sexual assault | Experimental | Behavioral: Online guided self-help intervention for sexual distress following sexual assaultThe intervention only has one arm. All participants will be provided 4 sessions of guided self-help intervention to be completed once weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cis female
- 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
Key exclusion criteria (3 listed)
- experiencing severe acute mental health difficulties
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online guided self-help intervention for sexual distress following sexual assault4 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. | Behavioural | Online guided self-help intervention for sexual distress following sexual assault |
Primary outcome
Client Satisfaction Questionnaire (CSQ)
Time frame: At follow up, 8 weeks
The client satisfaction questionnaire is an 8-item questionnaire scored on a 4-point scale and will be provided to participants at follow up to ask the acceptability and satisfaction towards the intervention. Permission has been asked to adapt the questionnaire to focus on satisfaction for the intervention instead of service satisfaction. Total scores range from 8 to 32 with higher scores indicating higher satisfaction.
Feedback Form
Time frame: At follow up, 8 weeks
A short qualitative feedback form will be provided to participants. This form has been developed with experts by experience and will have open ended questions for participants to provide more detailed feedback about the intervention. The questionnaire is only used at follow up.
5 secondary outcomes
Baseline Visual Analogue Scales
Time frame: Completed daily up to 2 weeks
Intervention Visual Analogue Scales
Time frame: Completed daily up to 1 month
Female Sexual Distress scale - Revised (FSDS-R)
Time frame: Baseline and 8 weeks
Female Sexual Function Index (FSFI)
Time frame: Baseline and 8 weeks
State Self Compassion Questionnaire (SSCS-S)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
Related trials for Sexual Assault
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Not yet recruitingPhase 2
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Chronic Musculoskeletal Pain, Sexual Assault
Active, not recruiting
uSafeUS+ App Pilot Testing
Alcohol Consumption, Sexual Assault
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Vosper principal investigator
Bart's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online guided self-help intervention for sexual distress following sexual assault in people with Sexual Assault and Sexual Dysfunction, run by Royal Holloway University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (CSQ) (time frame: At follow up, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.