Online Guided Self-help Intervention for Sexual Distress Following Sexual Assault: A Single Case Experimental Study
Phase: NA
Conditions: Sexual Assault, Sexual Dysfunction, Sex Disorder
Sponsor: Royal Holloway University



Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
2 
 
PROTOCOL 
 
Title: Online guided self-help intervention for sexual distress following sexual assault: A 
single case experimental study   
 
 
Short Title: Guided Self Help Following Sexual Assault: SCED                                                         
 
 
 
IRAS Project ID: 313482  
 
 
Sponsor: 
Royal Holloway, University of London 
Egham, Surrey 
TW20 0EX 
 
Chief Investigator:  
Kimberley Khoo  
Doctorate in Clinical Psychology, Department of Psychology  
Royal Holloway, University of London 
Egham, Surrey 
TW20 0EX 
Telephone: +44 07492418618 
Email: njjt001@live.rhul.ac.uk 
 
Supervisors:  
Andy Macleod 
Director 
Doctorate in Clinical Psychology 
Royal Holloway, University of London 
Egham, Surrey 
TW20 0EX 
Email: A.Macleod@rhul.ac.uk 
 
Jane Vosper 
Clinical Psychologist 
Doctor of Clinical Psychology (DClinPsy) 
Barts Health NHS Foundation Trust 
Sexual Wellbeing Service 
Grahame Hayton Unit Ambrose King Centre Royal London Hospital, 
Whitechapel 
E1 2BB 
Email: jane.vosper3@nhs.net 
 
 
 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
3 
 
Contents  
Synopsis study ………………………………………………………………………………..5  
1. Background and rationale ………………………………………………………….…6 
1.1 Need for research in this area …………………………………………………….…..6 
1.2 Aims……………………………………………………………………………….….6 
1.3 Objectives…………………………………………………………………………..…7 
2. Methods…………………………………………………………………………….…7 
2.1 Study design……………………………………………………………………….….7 
2.2 Recruitment and participant screening……… …………….…………………………8 
2.2.1 Inclusion criteria…………………………………………………………………11 
2.2.2 Exclusion criteria   ………………………………………………………………11 
2.2.3 Criteria for premature withdrawal………………………………………………..12 
2.3 Materials provided to participants…………………………………………………....12 
2.3.1 Intervention ………………………………………………………………..….….12 
2.3.2 Visual Analogue Scales……………………………………………………….….13 
2.3.3 Female Sexual Dysfunction Scale………………………………………………..13 
2.3.4 Female Sexual Functioning Index…………………………………………….….14 
2.3.5 State Self Compassion Scale……………………………………………………...14 
2.3.6 Client Satisfaction Questionnaire…………………………………………….......14 
2.3.7 Feedback form……………………………………………………………………14 
2.4 Expert by experience involvement……………………………………………………15 
3. Study procedure………………………………………………………………………15 
3.1 Informed consent procedures ...………………………………………………..….…16 
3.2 Data collection methods ……………………………………………………………..16 
3.3 Statistical analysis of data……………………………………………………………17 
3.4 Risk and burdens……………………………………………………………………..17 
3.5 Study end definition …………………………………………………………………19 
3.6 Pause criteria for study  
4. Assessment of safety………………………………………………………………….19 
5. Data security management and confidentiality ………………………………...……20 
5.1 Data storage and handling and confidentiality ……………………....………………20 
5.2 Data preservation…………………………………………………………………….21 
6.Publication of results……………………………………………………..………...…..21 
 
 
 
 
 
 
 
 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
4 
 
 
Study Synopsis 
Full Title 
Online guided self-help intervention for 
sexual distress following sexual assault: A 
single case experimental study   
Short Title  
Guided self-help following sexual assault - 
SCED 
Protocol version number and date  
V2 250722 
Study duration  
10 months 
Study design  
Single Case Experimental Design   
Sponsor  
Royal Holloway, University of London   
Chief Investigator 
Kimberley Khoo 
IRAS Project ID  
313482 
 
Primary objective  
To test the acceptability and feasibility of an 
online guided self-help intervention by 
female survivors of sexual assault who 
experience sexual distress 
Secondary objective 
To gain an initial indicator on the 
effectiveness of the intervention 
Number of subject 
6 
Main inclusion criteria  
Cis-female over the age of 18 with an 
experience of sexual assault that occurred 
over 12 months ago 
Statistical methodology and analysis  
Descriptive 
statistics, 
visual 
analysis, 
reliable change index.  

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
5 
 
1. Background & Aims of the project 
1.1 Need for research in this area 
Sexual assault (SA) is associated with enduring negative impacts, including interpersonal, 
psychological and physical difficulties (Maniglio, 2009; Chen et al., 2010). SA survivors 
develop a different relationship with sex (O’Callaghan et al., 2018) and report less interest in 
sex, reduced desire, fear of sex, arousal dysfunction and painful sex (Norris & Feldman-
Summers, 1981; Weaver, 2009). They also experience high levels of shame, self-blame and 
decreased self-compassion and attachment-based difficulties (Hamrick & Owen, 2019).  
 
Despite the prevalence of these difficulties, there is limited research identifying treatment. 
Systematic reviews investigating the effectiveness of psychological interventions in SA 
survivors do not mention sexual distress, suggesting that interventions are limited or do not 
consider sexual distress (Regehr et al., 2013; Parcesepe et al., 2015). Instead, they target 
generic distress related to trauma. Evidence from a meta-analysis suggests that psychological 
treatments for post-traumatic stress disorder following SA had no effect on sexual problems 
(O’Driscoll & Flanagan, 2015). On the other hand, traditional psychosexual therapy that aim 
to alleviate sexual distress does not consider the experience of SA trauma symptoms and how 
they may interact with standard psychosexual approaches (Althof et al., 2005). Meston and 
colleagues (2013) found that standard psychosexual therapy developed to alleviate sexual 
difficulties had inconsistent results among women with a history of SA, suggesting precedence 
for developing specific psychosexual intervention for SA survivors. Few studies explored 
specific interventions for sexual distress experienced by SA survivors; however, most of these 
studies do not adopt a formal model or follow a standard protocol (Gerwitz-Meydan, 2020).  

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
6 
This study proposes an online four-session guided self-help psychoeducational program for 
survivors of SA. Online guided-self-help is the chosen modality as it widens access to treatment 
in a population who may experience shame and stigma regarding help-seeking (Levin et al., 
2018). Previous studies, such as a pilot RCT found online guided self-help effective in 
improving sexual functioning in women with vaginismus (Zarski et al., 2017). A treatment 
protocol for Internet-based guided self-help has already been developed for sexual pain but not 
for sexual distress after SA (Zarski et al., 2018). This intervention aims to normalise and build 
women’s confidence on getting back to sex after experiencing SA. The objective is to reduce 
shame, self-criticism, sexual distress and improve sexual well-being. By exploring an 
individual’s difficulties through a normalising framework, the intervention aims to increase 
their awareness of their difficulties and build confidence, skill and motivation to alleviate 
sexual distress. As this is a novel intervention, the study adopts a single-case experimental 
design (Morley, 2017). It aims to test the acceptability and feasibility and potential 
effectiveness of the intervention.  
To our knowledge, no research projects have developed guided self-help materials for female 
survivors of sexual abuse targeting sexual distress. The project has taken guidance from experts 
by experience to develop materials collaboratively. Clinical psychologists from Bart's NHS 
Trust Sexual Wellbeing Service, where similar materials have been used in a group setting 
have also provided feedback.  
1.2 Aims  
- 
To investigate the feasibility and acceptability of a 4-session guided self-help 
psychosexual intervention for survivors of sexual abuse  
- 
Initial indicator of effectiveness in reducing sexual distress  

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
7 
- 
Improving sexual satisfaction– specifically confidence in practicing strategies that will 
improve their relationship and experience of sex 
1.3 Study objectives 
Primary objectives   
a. The objective of the study is to investigate the feasibility and acceptability of a 4-
session guided self-help intervention for female survivors of sexual assault to gather an 
initial indicator of effectiveness in reducing sexual distress.  
b.  Is the intervention viewed as acceptable by female survivors of sexual assault? We will 
be defining ‘acceptability’ as how willing participants are to use the materials and its 
content (Bowen et al., 2009). 
Secondary objectives  
The secondary outcomes are whether the study suggest the intervention is effective.  Is there 
an initial indicator that the intervention effective? Effectiveness is measured by reduction in 
the measure of sexual distress and improvement of sexual satisfaction – specifically confidence 
and motivation in practicing strategies that will improve their experience of sex. 
 
2. Methods 
2.1 Study design  
The study adopts a single-case experimental design (SCED). This study design is helpful in 
testing the novelty and feasibility of an intervention. 
Potential participants will be invited to follow a link to a Qualtrics survey. The Qualtrics survey 
provides detailed information about the study. Participants will undergo screening for 
eligibility and risk via Qualtrics. Should individuals wish to participate and are eligible, they 
can give informed consent by reading a set of statements on Qualtrics relating to the study 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
8 
information. Eligible participants will fill in questionnaires such as the FSDI, FSFI, SCSS-S, 
at this point. Participants will undergo a baseline period known as phase A, varying between 
5- 14 days where they will fill in visual analogue scales daily. The number of days participants 
will be in baseline will be randomly allocated by a randomiser. There are 6 visual analogue 
scales measuring shame, guilt, self-criticism, self-compassion, normalising and motivation.  
After phase A, participants will undergo phase B, which is a 4-week intervention period where 
participants go through 1 module of the guided-self-help materials each week and complete the 
same visual analogue scales from baseline every day. After phase B, participants will be invited 
for a follow-up appointment one month after the intervention to fill in the FSDS, FSFI, client 
satisfaction questionnaire (Larsen et al., 1979) and feedback form developed with experts by 
experience.   
 
2.2 Recruitment and participant screening 
The study will be advertised through Barts NHS Trust Sexual Wellbeing Service with 
information put on leaflets circulated within the clinic. Clinicians may also provide an 
information sheet to clients with a weblink the study details and screening questionnaire. 
Additional recruitment will be done on My Body Back, an organisation who works with 
women with experience of sexual assault, in London and Glasgow. My Body Back will 
advertise the study on its website and at its events, providing a web link to the study details 
and initial screening questionnaire. The intervention will be offered whilst women are on the 
waiting list. They will not lose their place on the waiting list if they take part.  
 
General social media advertising will also be done through different charities and communities 
who work with female survivors of sexual assault. Potential participants will be encouraged to 
take some time to think about whether or not they would like to participate. Individuals will be 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
9 
informed that participation is on a voluntary basis and consent can be withdrawn at any time. 
They will also not lose their place on the waiting list for services. Statistical power analyses 
have been underdeveloped for SCED (Arntz et al., 2013). For a SCED, only 1 participant is 
required for analysis but, Lanovaz & Rapp (2015) suggest a ‘3 point guideline’ as the minimum 
requirement for control of study design. Having more than 3 participants will also improve the 
generalization of findings (Kratochwill et al., 2013). Considering this and to account for 
attrition, we aim to recruit 20 participants with a minimum sample size of 6 participants.  
 
Should individuals wish to participate they will be invited to follow a link to a Qualtrics survey 
to initial screening questions to check for eligibility. Prior to completing the screening 
questionnaire participants will be provided the following text ‘Thank you for being interested 
in this study. The next step is to complete a screening questionnaire. This questionnaire aims 
to determine if this study would be appropriate for you. The questionnaire does not ask you 
direct questions about your experience of sexual assault; however, it could potentially elicit 
difficult emotions. Please keep this in mind if you decide to proceed with the questionnaire as 
your wellbeing is a priority. There are no consequences if you decide to opt out of participating 
in this study. At the end of the questionnaire, we have included the chief investigator's email 
along with signposting information about services you can contact if you require additional 
support. Thank you for your time.’ These questions will confirm if participants are 
experiencing difficulties with sex, have been sexually assaulted over 12 months ago, if they 
are currently receiving other forms of psychological intervention and have access to a smart 
phone or computer to access materials. The Patient Health Questionnaire 2-item (PHQ-2) and 
Generalised Anxiety Disorder 2-item (GAD-2) are incorporated in the screening questionnaire 
not to screen for depression and/or anxiety but provide an indication of participant 
demographic.  There will also be a risk screen based on the PHQ-9 "Over the past two weeks, 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
10
how often have you been bothered by thoughts that you would be better off dead or of hurting 
yourself in some way?" - Not at all, Several days, More than half of the days, Nearly every day 
and a question about support from family and friends.  Those who rate themselves as 
experiencing thoughts of death or self-harm and do not indicate that they have social support 
or psychological support will not be eligible to participate (see section. Those ineligible to 
participate will be redirected to a debrief page, ‘debrief page for Qualtrics’, which will include 
an explanation of why this is the case and signposting to relevant resources. They will also be 
provided with the chief investigators email or given the option to leave their telephone number 
for the chief investigator to call them and discuss why they were not appropriate for the study.  
Eligible participants will provide informed consent by reading statements relating to the study 
information and writing their initials if they consent to each statement. This includes 
confirming they have read the information, understanding participation is voluntary and being 
able to withdraw from the research at any time. Participants are asked to provide their GP 
details as part of informed consent. Participants will be informed that their GP will not be 
notified about their involvement in the study or provided any information contributed whilst 
participating. We will only contact their GP if there are identified risks. These risks include 
increased self-harm behaviour, increased suicidal risk or significant deterioration of mental 
health. Under these circumstances, confidentiality may be breached and, the chief investigator 
may contact the participants GP. As there is little to no professional contact as part of the study 
design, the chief investigator will only be made aware of increased risk if the participant raises 
it to the chief investigator by email.  
 
Eligible participants who provide informed consent will have a screening call with the lead 
investigator, Kimberley Khoo to verify risk, confirm consent and answer any additional 
questions about the study. As the intervention is online, we hope that having a call at the 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
11
beginning will increase engagement through the study. After the screening call, participants 
will be asked to fill in a participant demographic sheet and provide their name, age, ethnicity, 
email address (for contact), region in the UK they live in, employment status and if they are 
currently or have previously accessed psychological therapy and what type of therapy they 
received. In addition, participants will complete the Female Sexual Distress scale – Revised 
(FSDS-R; Derogatis et al., 2002), Female Sexual Function Index (FSFI; Rosen et al., 2000) 
and State Self Compassion Questionnaire (SSCS-S; Neff et al., 2021).  
 
2.2.1 Inclusion criteria  
- 
Cis female experiencing sexual distress with a history of sexual trauma 
- 
Willingness to complete guided self help  
- 
Aged 18 and above 
- 
Ability to read English to provide consent and meaningfully engage with the self-help 
materials  
- 
Ability to access online guided self-help material through a computer or phone 
- 
Not currently experiencing severe acute mental health problems  
- 
Not currently suicidal or self-harming  
 
2.2.2 Exclusion criteria 
Participants will be excluded if they are experiencing severe acute mental health difficulties,  
sexual assault occurring within the last 12 months or 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 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
12
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).  
 
 
2.2.3 Criteria for premature withdrawal  
Participants will be able to withdraw from the study at any point by informing the chief 
investigator   
 
2.3 Material provided to participants.  
2.3.1 Intervention  
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. The 
intervention handout and scripts is in the document titled ‘Intervention Manual V1’. 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. 
Additional handouts for each session can be found in the appendix.  
2.3.2 Visual Analogue Scales 
Visual analogue scales are to be completed by participants. Visual analogue scales are scales 
with two ends where participants will be asked to rate how much they agree or disagree with 
the following statements as seen in figure 1 below:  

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
13
• 
Shame  
o I feel shame when I experience sexual distress   
• 
Guilt  
o I have feelings of guilt when I experience sexual distress   
• 
Self-criticism   
o When I experience sexual distress, how often do I blame myself or my body?  
• 
Compassion  
o When I experience sexual distress, I try to show myself warmth and comfort 
through my difficulties   
• 
Normalising  
o I understand my difficulties in the context of my experience   
• 
Motivation   
o I am motivated to put things in place to improve/ address the difficulties in my 
sex life 
Figure 1: VAS Example 
 
 
Disagree                                                                                                                                       agree 
2.3.3 Female Sexual Distress scale – Revised (FSDS-R; Derogatis et al., 2002) 
The FSDS-R is used to assess distress related to sex in women (Derogatis et al., 2002). This 
13-item self-report questionnaire is scored has four points, (0: never; 1: rarely; 2: occasionally; 
3: frequently). In multiple studies involving more than 500 women, the FSDS-R has shown 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
14
high internal consistency (Dergostis et al., 2008) for women with and without sexual 
difficulties. A validation study demonstrate that the measure has discriminant and content 
validity (Dergostis et al., 2008). The FSDS-R is completed upon recruitment and at the 1 month 
follow up.  
2.3.4 Female Sexual Function Index (FSFI; Rosen et al., 2000) 
The FSFI is a 19-item questionnaire that measures six domains: desire, arousal, lubrication, 
orgasm, satisfaction and pain. The questionnaire has been used in different clinical trials and 
epidemiological studies and have shown to have high test-rested reliability and validity, it is 
scored from 1 to 5 with different response options. The FSFI is completed upon recruitment 
and at the 1 month follow up. 
2.3.5 State Self Compassion Questionnaire (SSCS-S; Neff et al., 2021) 
The SSCS-S is a 6-item questionnaire scored on a 5-point scale from 1 (not very true for me) 
to 5 (very true for me). In one study, Neff et al (2021) reports the SSCS-S had a strong 
correlation (r=.96) to the long version of the state self-compassion questionnaire and showed 
good reliability (α = .86). Another study found strong construct validity. The SCSS-S is 
completed upon recruitment and at the 1 month follow up.  
 
2.3.6 Client Satisfaction Questionnaire (CSQ; Larsen et al., 1979) 
The CSQ 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. The 
questionnaire has high construct validity and internal consistency. Permission has been seeked 
to adapt the questionnaire to focus on satisfaction for the intervention instead of service 
satisfaction. Awaiting response. The questionnaire is only used at follow up.  
2.3.7 Feedback Form  

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
16
The study is conducted via Qualtrics, an online survey platform. A survey link will be emailed 
to participants for them to complete in their own environment. This allows the study to be 
completed anywhere. The survey will be live for 5 months of data collection before being taken 
offline. Participants will also be sent handouts of each week’s intervention. After completing 
the screening questionnaire, eligible participants will be asked to fill in the FSDS-R, FSFI and 
SCSS. These questionnaires are filled in once weekly during phase A and B.  
During Phase A which varies between 5- 14 days, participants will be sent Qualtrics links to 
where fill in visual analogue scales daily. The number of days’ participants will be in baseline 
will be randomly allocated. There are 6 visual analogue scales that measure shame, guilt, self-
criticism, self-compassion, normalising and motivation.  
During phase B participants go through 1 module of the guided-self-help materials each week 
and complete the same visual analogue scales from baseline every day. After phase B. 
participants will be invited for a follow-up appointment one month after the intervention to fill 
in the FSDS, FSFI, SSCS-S client satisfaction questionnaire and feedback form developed with 
experts by experience.   
 
3.1 Informed consent procedures   
Participants will be asked for informed consent via the Qualtrics survey which states they are 
aware of the consequence of taking part in the study and understand the information sheet 
provided to them. Participants are also provided with the email address of the Chief 
Investigator who they can reach out to with any queries before or after taking part. The study 
advertisement will provide brief information about the study. If interested, women will be 
directed to the online weblink to read through more detailed study information. It will be clearly 
stated that participation is voluntary and participants may drop out at any time and withdraw 
consent even after completing the project. It will be clearly stated that the intervention is 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
17
provided through online self-help that individuals work through on their own and does not 
entail personal support from a psychology team. Through a weblink, participant will tick boxes 
to provide informed consent, confirming they consent and understand these terms and asked to 
write their name as a way of providing consent. 
 
3.2 Data collection methods  
Data collection will be conducted through Qualtrics. During phase A and B, data is collected 
daily.  
 
3.3 Statistical analysis of data  
Descriptive statistics will be completed for demographic information. Visual analysis will be 
performed for daily VAS ratings to evaluate the reliability of treatment effects between the 
baseline and treatment phases. To investigate if there is pre-and post-difference between scores 
a reliable change index (RCI) will be calculated for each measure using Jacobson & Traux 
(1991) to test if changes are statistically significant. Tau-U test will be used on outcomes to 
analyse non-overlap of intervention scores. Guidance and procedures will be followed from 
What Works Clearing House (Kratochwill et al., 2010). 
 
3.4 Risk and burdens 
Participants will not be asked to disclose or directly think about their experience of sexual 
assault. The materials developed is to provide psychoeducation and build self-compassion 
through a normalising framework that will ask participants to reflect on their sex lives and how 
past experiences can affect their experience of sex. This may be difficult and upsetting for some 
participants. In order to counter this risk, information and signposting regarding crisis 
psychological support will be provided to participants at the beginning and end of each self-

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
18
help resource throughout the intervention. Participants will have access to Jane Vosper, 
Clinical Psychologist and two other clinicians at the Barts NHS Trust Sexual Wellbeing 
Service during the length of project for triage if adverse reactions are identified. Participants 
will be able to email the lead investigator and provide consent for the investigator inform Jane 
to get in touch with them. Participants will be informed they are able to reach the head 
investigator from 9am to 4pm on weekdays. Outside office hours they will be signposted to 
other support lines. It will be made clear to participants that besides this one appointment, the 
researchers cannot provide further advice or medical treatment  
Participants should contact their GPs if they have concerns for their mental or physical health. 
Participants are required to provide GP details when providing informed consent. The GP will 
not be notified of the participants involvement in the study. We will only contact their GP if 
there are identified risk such as severe self-harming, suicidal risk or a significant deterioration 
in mental health. Under these circumstances, confidentiality may be breached. As the study is 
utilising a self-help intervention, there will be an expectation that participants will be able to 
make practical decisions about their readiness to begin the intervention, their ability to cope 
and access additional support if required. This expectation will be clearly outlined in the 
participant information sheet and consent form.  
 
Participants will be assessed on their risk to self during screening and receive a follow-up 
screening call from the head investigator. Participants who disclose high risk who are not 
accessing mental health services will be excluded from participating to prevent further distress 
that may be triggered during the intervention. Participants will be made aware that the 
researcher cannot provide advice or medical treatment and that they should contact their GP as 
a first step if they have concerns regarding their mental or physical health. Participants will be 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
19
able to provide details of their GP who can be informed that they are taking part in the study, 
however this is not compulsory.  
 
Overall, the potential benefits of this study are thought to outweigh the risk. The intervention 
content is based on compassion-focused therapy and content that is already used by Barts NHS 
trust Sexual Wellbeing Service to improve sexual wellbeing. Participants can access the 
materials while waiting to be seen by these services, both of which have a long wait time.  
 
3.5 Study end definition  
The study will be considered finished when the statistical analysis has been conducted and 
completed as seen as appropriate.  
 
3.6 Pause criteria  
If more than 4 participants within eight weeks get in contact with the chief investigator 
requesting a 1:1 support session provided by clinicians at Bart’s NHS Foundation Trust Sexual 
Wellbeing Clinic due to adverse effects from the intervention, the study may be paused. This 
number was decided as it represents 25% of our recruitment goal. The study would have to be 
paused due to clinician availability. If this occurs, the researchers will have a meeting with the 
service lead at Bart’s NHS foundation trust Sexual Well-Being Clinic. This meeting will 
discuss the feasibility of continuing the study and potentially pausing the study and changing 
the recruitment strategy.  
 
4. Assessment of safety  

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
20
As the study is utilising a self-help intervention, there will be an expectation that participants 
will be able to make practical decisions about their readiness to begin the intervention, their 
ability to cope and access additional support if required. This expectation will be clearly 
outlined in the participant information sheet and consent form. Participants will be able to email 
the lead investigator and provide consent for the investigator inform Clinicians at Bart’s NHS 
Foundation trust to get in touch with them. Participants will be informed they are able to reach 
the head investigator from 9am to 4pm on weekdays. Outside office hours they will be 
signposted to other support lines.  
If participants report identified risks, they will be supported through the 1:1 personal support 
session provided by Bart’s NHS Foundation Trust, Sexual Wellbeing Service. However, 
confidentiality may be breached if the clinicians or the chief investigator are still concerned 
about risk. The chief investigator will first discuss this with the participant if this occurs. 
Subsequently, an urgent email (GP Letter V2) will be sent to the participant's GP via NHS 
email. A phone call will also be made to the GP to ensure the GP is informed.   
 
5. Data security, management and confidentiality  
5.1 Data storage, handling and confidentiality  
All computerised data will be stores and encrypted on a password protected USB drive that 
adheres to the NHS confidentiality standards.  
Participants will provide email address so that they can be sent links to the self-help materials 
each week as well as links to questionnaire and prompt emails.  Names are only used when 
giving consent and for demographic information. Participants will then be allocated a 
participation ID number for reference to fill in questionnaires and not linked to names. A 
separate key associating the ID number with the participants’ names will be stored apart from 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
21
the data and destroyed once it is no longer necessary to contact participants or obtain further 
information about them (e.g., once a journal article is published), this file will be password 
protected. 
All information will be submitted through Qualtrics which is a secure and confidential 
platform. Data will be downloaded, password protected and kept on a secure USB stick, only 
accessible to the researcher.  
Database containing any personal information will be deleted following the final write-up of 
the research. 
No members of the research team will have access to participants' personal medical records or 
any clinical data beyond that voluntarily provided by the participants when they choose to 
participate in the study. This information provided will only be seen by the chief investigator 
and will be kept securely in a password protected database, 
separately to the research data. 
Data will be analysed on a personal laptop by the Chief Investigator at Royal Holloway, 
University of London. All data will be saved on a password protected encrypted USB 
(approved by RHUL and sponsor) that only the chief investigator has access to. This will not 
include any personally identifiable data. Data is anonymised and each participant is given a 4-
digit participant code using random numbers and letters. 
5.2 Data preservation  
The research data will be kept in a database (as discussed in A36) which will be retained by Dr 
Andy Macleod, who is supervising this research on behalf of Royal Holloway, University of 
London, Data is kept for up to five years, for audit purposes. 
This database will contain no personally identifiable information and will be password 
protected. Only Dr Andy MacLoed will hold the password. Consent forms will be kept for 2 
years. 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
22
6. Publication of results  
The study will be published as a doctoral thesis and may be published in peer reviewed 
scientific journals or presented in conferences.  
 
 
 
 
 
References 
Arntz, A., Sofi, D., & van Breukelen, G. (2013). Imagery rescripting as treatment for 
complicated PTSD in refugees: a multiple baseline case series study. Behaviour Research and 
Therapy, 51(6), 274-283. 
 
Althof, S. E., Leiblum, S. R., Chevret‐Measson, M., Hartmann, U., Levine, S. B., McCabe, M., 
... & Wylie, K. (2005). Psychology: Psychological and interpersonal dimensions of sexual 
function and dysfunction. The journal of sexual medicine, 2(6), 793-800. 
 
Boersma, K., Håkanson, A., Salomonsson, E., & Johansson, I. (2015). Compassion focused 
therapy to counteract shame, self-criticism and isolation. A replicated single case experimental 
study for individuals with social anxiety. Journal of Contemporary Psychotherapy, 45(2), 89-
98. 
 
Bowen, D. J., Kreuter, M., Spring, B., Cofta-Woerpel, L., Linnan, L., Weiner, D., ... & 
Fernandez, M. (2009). How we design feasibility studies. American journal of preventive 
medicine, 36(5), 452-457. 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
23
 
Chen, L. P., Murad, M. H., Paras, M. L., Colbenson, K. M., Sattler, A. L., Goranson, E. N., ... 
& Zirakzadeh, A. (2010, July). Sexual abuse and lifetime diagnosis of psychiatric disorders: 
systematic review and meta-analysis. In Mayo clinic proceedings (Vol. 85, No. 7, pp. 618-
629). Elsevier. 
 
Derogatis, L. R., Rosen, R., Leiblum, S., Burnett, A., & Heiman, J. (2002). The Female Sexual 
Distress Scale (FSDS): Initial validation of a standardized scale for assessment of sexually 
related personal distress in women. Journal of Sex &Marital Therapy, 28(4), 317-330. 
 
DeRogatis, L., Clayton, A., Lewis-D'Agostino, D., Wunderlich, G., & Fu, Y. (2008). 
Validation of the female sexual distress scale-revised for assessing distress in women with 
hypoactive sexual desire disorder. The journal of sexual medicine, 5(2), 357-364. 
 
 
Gewirtz-Meydan, A. (2020). The relationship between child sexual abuse, self-concept and 
psychopathology: The moderating role of social support and perceived parental 
quality. Children and youth services review, 113, 104938. 
 
Hamrick, L. A., & Owens, G. P. (2019). Exploring the mediating role of self‐blame and coping 
in the relationships between self‐compassion and distress in females following the sexual 
assault. Journal of clinical psychology, 75(4), 766-779. 
 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
24
Jacobson, N. S., & Truax, P. (1991). Clinical significance: A statistical approach to defining 
meaningful change in psychotherapy research. Journal of Consulting and Clinical Psychology, 
59(1), 12 –19. 
 
Jones, S., Ownsworth, T., & Shum, D. H. (2015). Feasibility and utility of telephone-based 
psychological support for people with brain tumor: a single-case experimental study. Frontiers 
in oncology, 5, 71. 
 
 
Kazdin, A. E. (2019). Single-case experimental designs. Evaluating interventions in research 
and clinical practice. Behaviour research and therapy, 117, 3-17. 
 
Kratochwill, T. R., Hitchcock, J., Horner, R. H., Levin, J. R., Odom, S. L., Rindskopf, D. M., 
& Shadish, W. R. (2010). What Works Clearinghouse single-case design technical 
documentation version 1.0. 
 
 
Kratochwill, T. R., Hitchcock, J. H., Horner, R. H., Levin, J. R., Odom, S. L., Rindskopf, D. 
M., & Shadish, W. R. (2013). Single-case intervention research design standards. Remedial 
and Special Education, 34(1), 26-38. 
 
 
Larsen, D. L., Attkisson, C. C., Hargreaves, W. A., & Nguyen, T. D. (1979). Assessment of 
client/patient satisfaction: development of a general scale. Evaluation and program 
planning, 2(3), 197-207. 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
25
 
Levin, M. E., Krafft, J., & Levin, C. (2018). Does self-help increase rates of help seeking for 
student mental health problems by minimizing stigma as a barrier. Journal of American College 
Health, 66(4), 302-309. 
 
 
Manolov, R., Gast, D. L., Perdices, M., & Evans, J. J. (2014). Single-case experimental 
designs: Reflections on conduct and analysis. Neuropsychological rehabilitation, 24(3-4), 634-
660. 
 
McLean, L., Steindl, S. R., & Bambling, M. (2018). Compassion-focused therapy as an 
intervention for adult survivors of sexual abuse. Journal of child sexual abuse, 27(2), 161-175. 
 
Regehr, C., Alaggia, R., Dennis, J., Pitts, A., & Saini, M. (2013). Interventions to reduce 
distress in adult victims of rape and sexual violence: A systematic review. Research on Social 
Work Practice, 23(3), 257-265. 
 
Rosen, C. Brown, J. Heiman, S. Leiblum, C. Meston, R. Shabsigh, D. Ferguson, R. D'Agostino, 
R. (2000). The Female Sexual Function Index (FSFI): a multidimensional self-report 
instrument for the assessment of female sexual function. Journal of sex & marital 
therapy, 26(2), 191-208. 
 
Parcesepe, A. M., Martin, S. L., Pollock, M. D., & Garcia-Moreno, C. (2015). The 
effectiveness of mental health interventions for adult female survivors of sexual assault: A 
systematic review. Aggression and violent behavior, 25, 15-25. 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
26
 
Lanovaz, M. J., & Rapp, J. T. (2016). Using single-case experiments to support evidence-based 
decisions: How much is enough?. Behavior Modification, 40(3), 377-395 
 
Maniglio, R. (2009). The impact of child sexual abuse on health: A systematic review of 
reviews. Clinical psychology review, 29(7), 647-657. 
 
Meston, C. M., Lorenz, T. A., & Stephenson, K. R. (2013). Effects of expressive writing on 
sexual dysfunction, depression, and PTSD in women with a history of childhood sexual abuse: 
Results from a randomized clinical trial. The Journal of Sexual Medicine, 10(9), 2177-2189. 
 
Norris, J., & Feldman-Summers, S. (1981). Factors related to the psychological impacts of rape 
on the victim. Journal of Abnormal Psychology, 90(6), 562. 
 
Tate, R. L., Perdices, M., McDonald, S., Togher, L., & Rosenkoetter, U. (2014). The design, 
conduct and report of single-case research: Resources to improve the quality of the 
neurorehabilitation literature. Neuropsychological Rehabilitation, 24(3-4), 315-331. 
 
O’Callaghan, E., Shepp, V., Ullman, S. E., & Kirkner, A. (2019). Navigating sex and sexuality 
after sexual assault: A qualitative study of survivors and informal support providers. The 
Journal of Sex Research, 56(8), 1045-1057. 
 
O'Driscoll, C., & Flanagan, E. (2016). Sexual problems and post‐traumatic stress disorder 
following sexual trauma: A meta‐analytic review. Psychology and Psychotherapy: Theory, 
Research and Practice, 89(3), 351-367. 

Guided Self Help Following Sexual Assault: SCED                                                         
V2 10/10/22  
IRAS: 313482 
 
 
27
 
Weaver, T. L. (2009). Impact of rape on female sexuality: Review of selected 
literature. Clinical Obstetrics and Gynecology, 52(4), 702-711. 
 
Zarski, A. C., Berking, M., Fackiner, C., Rosenau, C., & Ebert, D. D. (2017). Internet-based 
guided self-help for vaginal penetration difficulties: results of a randomized controlled pilot 
trial. The journal of sexual medicine, 14(2), 238-254.