Feasibility and Acceptability of Medical Skin Camouflage for Recovery of Women With Self-Harm Scarring in Prison
Phase: NA
Conditions: Self Injurious Behaviour
Sponsor: University of Manchester

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COVER Study Protocol 
Full Study Title: Feasibility and Acceptability of Medical Skin Camouflage for Recovery of Women 
with Self-Harm Scarring in Prison: Phase 3 & 4 
 
Research Team: 
Professor Kathryn Abel: Principal Investigator 
Dr Kerry Gutridge: Project Manager 
Mr Brendan Dunlop: Research Assistant 
Rachel Meacock: Health Economics 
Professor Matt Sutton: Supervision of Rachel Meacock 
Professor Christopher Roberts: Statistics 
Professor Jennifer Shaw: Advice on prison research 
Dr Louise Robinson: Advice on prison research 
Dr Sandeep Ranote: Advice on skin camouflage for self-harm 
Dr Tammi Walker: Qualitative research 
Mark Craven: Local collaborator in the prison 
Sponsor:  
University of Manchester 
Summary:  
Women prisoners (WPs) comprise 5% of the prison population but are far more likely to commit 
suicide or self-harm (SH) than women in the community or male prisoners. Healthcare services have 
significantly improved the management of acute SH crises in the community and prison service but 
there has been little focus on the recovery, psychosocial functioning and quality of life for those 
living with SH scarring. Medical skin camouflage (MSC) clinics treat individuals with disfiguring 
conditions like burn scars and show evidence of improved recovery and psychosocial wellbeing. 
There is little/no evidence about MSC interventions with SH scarring or prisoners in the UK. 
 
AIM: To test feasibility and acceptability to women prisoners with SH scarring of delivering MSC in a 
women’s prison. 
 

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METHODS:  
A separate ethics application was completed for Phase 1 and 2. These initial stages have been 
completed.  
 
Phase 1: 2 stakeholder focus groups were run to explore practical aspects of delivering the medical-
skin camouflage in a women’s prison and to inform the choice of outcome measures. One focus 
group involved prison staff; the outcomes of this group focussed on practical aspects of delivering 
the intervention and standard operating procedures for protecting participants. The other focus 
group involved women prisoners with experience of self-harm; this group helped us to develop a set 
of women-centred, research-focussed outcome measures and explored the involvement of long-
term prisoners as MSC practitioners. Women prisoners also discussed how they could be protected 
during the research in terms of confidentiality, bullying and abuse.  
 
Phase 2: The findings from the 2 focus group were used to develop the procedure for phase 3 and 4 
of the research. Focus group discussion enabled us to determine where, when and how treatment 
would be delivered, how the women and researchers should be protected during the research and 
which important outcomes to measure. In phase 2 we developed a training manual for the long term 
prisoners and an appointment checklist to ensure that they could remember the key learning points 
regarding MSC application when they train the participants in phase 4. To ensure that the long-term 
prisoners remember the aspects of the training which address confidentiality and protection of 
themselves and other women, we developed a summary card of the main points from this part of 
the training. We also developed a monitoring sheet for the long-term prisoners so they can record 
any questions or difficulties they have when they are training women to discuss with researchers at 
the weekly debriefing. Following feedback from the staff group, we also developed a list of do’s and 
don’ts for the women in phase 4 so they can easily see how to comply with the research procedures. 
On the suggestion of the staff, and with an enthusiastic response from the women, we developed a 
diary for women to record their thoughts and actions regarding self-harm during the research 
period. The women’s focus group also informed the development of the interview schedules and 
topic guide for the phase 4 qualitative research and the revisions of the scales to be used at baseline 
and follow up. Discussion with prison staff regarding access to medical skin camouflage also lead to 
the development of a GP referral letter which was modelled on a template letter successfully used in 
the community. 
 
 

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This application is for phase 3 and 4 of the project.  
 
Phase 3. Research staff will train 6 long-term prisoners to provide MSC. The project manager has 
received training in MSC and has been trained to provide training to other people. She has trained 
the Research Assistant (RA) and will train any Clinical Support Officers (CSOs) who are involved in the 
research.  
 
Phase 4. Evaluates feasibility/acceptability of prison-delivered medical skin camouflage with 40 
women prisoners: 20 will be randomised to the 6-week intervention; 20 women prisoners will be 
wait-list controls and receive the intervention after study completion. Pre and post-intervention, we 
shall pilot collection of: 
 
1. Women, service and research-centred outcomes from Phase I which include scales measuring 
psychosocial well-being, social functioning and everyday activities.  
2. A diary of be completed during the 6-week study period which measures self-harm thoughts and 
actions, life events and, for the intervention group, the use of the medical skin camouflage. 
3. The collection of data on resource use using proformas for staff to collect information from the 
different prison databases, e.g. NOMIS    
4. 3-month follow-up data collection.  
5. Data on recruitment, participation, retention and causes of drop-out.  
 
Justification for the proposed research: 
The aim of the study is to establish the feasibility and acceptability of medical skin camouflage for 
women with self-harm scarring in prison. Self-harm is a non-fatal act where an individual 
deliberately initiates behaviour (such as self-cutting), or ingests a substance or object intending to 
harm themselves (1). Rates of self-harm (incl. suicide) in England & Wales are amongst the highest in 
Europe (400/100,000 population/year) and have been rising over the last decade (2). Women 
comprise only 5% of the prison population but are responsible for the majority of prison self-harm 
and significantly more than comparably-aged women in the community (3-5) or male prisoners (6). 
Healthcare services have significantly improved their management of self-harm crises in the 
community and prison service (7) but there has been little focus on recovery, including psychosocial 
functioning and quality of life following self-harm.  
 

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Dealing with the effects of disfigurement (8) from self-harm scarring is largely unaddressed; 
currently a paucity of literature exists on recovery and psychological effects on individuals. In the UK, 
more than 390,000 individuals live with disfigurement from various non-self-harm causes which is 
psychologically challenging for adults trying to recover (9). Individuals with non-self-harm 
disfigurement struggle to cope with scarring and other pathology (10). They often face psychosocial 
difficulties adjusting to scarring (11) and its attendant stigma with negative outcomes for self-
esteem, self-confidence, interpersonal relationships and ultimately recovery (12). Social situations 
may also exacerbate psychological difficulties provoking individuals with non-self-harm scarring to 
isolate themselves, feeling excluded from social groups and society (13, 14). Furthermore, living with 
scars can be challenging in a society which values physical perfection/attractiveness highly (15, 16).  
 
Medical skin camouflage provides an essential resource for people with disfigurement from scarring, 
with the potential to restore self-esteem, confidence and therefore aid recovery (17-19). Medical 
skin camouflage uses BNF-listed preparations to disguise scars with the intention of normalising the 
appearance of the skin (20). The products include cover creams, liquids and powders that are 
waterproof, opaque and allow adherence to textured skin, including scarred areas. Each individual 
has a ‘bespoke cream colour’ and all the required products are available on NHS prescription at the 
discretion of the individual doctor (due to their status as borderline products). Only a handful of 
studies have evaluated the emotional/psychological benefits of medical skin camouflage. These have 
all been in dermatological diseases or burns scarring. They report significant psychological benefit, 
improved social and sexual relationships and the ability to secure employment (21-23). Despite this, 
few services offer medical skin camouflage for self-harm scarring (24). The current study has the 
added value that one of the co-applicants runs a new medical skin camouflage Service in partnership 
with Changing Faces – a registered charity, using volunteers to teach the medical skin camouflage 
techniques to people with mental health problems in the community. Preliminary findings from this 
innovative work indicate positive feedback from mental health service users with increased well-
being, confidence and ability to partake in social activities. 
 
In spite of the fact that self-harm is a considerable problem in prisons, there has been little focus on 
recovery or the use of medical skin camouflage in this setting. The project team has received 
feedback from individual medical skin camouflage practitioners who have used medical skin 
camouflage in HMP Holloway and HMP Eastwood Park. They report that the majority of women 
prisoners experience improved self-esteem and confidence as a result of using medical skin 
camouflage. However, no formal evaluation of outcomes related to recovery or improvement in 

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psychosocial functioning has been undertaken following use of medical skin camouflage in a prison 
environment and there are no published studies. In the phase 1 focus groups the women prisoners 
were enthusiastic about the products and said that they had the potential to improve their self-
esteem, relationships with others and participating in activities such as going to the gym. 
 
There are many potential benefits of promoting a recovery model of care: First, increased self-
esteem, confidence and overall quality of life for women prisoners; secondly, empowering women 
prisoners to take part in work and social activities which they might otherwise avoid; thirdly, prison 
staff currently have a limited portfolio with which to work with self-harm. Our previous work has 
shown that there is a difficult relationship between prisoners who self-harm and staff caring for 
them. Staff felt restricted in how to help women or manage self-harm. This intervention may 
empower staff to support a pathway of recovery for women with self-harm scarring and may 
promote positive attitudes about self-harm in the prison and its management amongst staff.  
 
There is limited evidence for the application and use of medical skin camouflage with women 
prisoners. Increasing the evidence-base using a women-and service-centred approach will help to 
develop medical skin camouflage so that a recovery model can be delivered to female services users 
in other settings such as secure services where self-harm management is also a significant problem. 
The main benefits of this study will be an increase in self-esteem, quality of life and recovery for 
women prisoners with self-harm scarring. We anticipate improving recovery provision may also 
importantly decrease the likelihood of repeated self-harm behaviour. It is also likely that an 
intervention reducing self-harm will save costs to prisons and NHS as users will use less staff time 
and less treatment costs in prison and on release as NHS service users. Women prisoners may 
become empowered to participate in work and social activities. Prison staff will benefit if a clinical 
intervention is more likely to encourage a recovery model of care, reduce management difficulties 
for staff and promote positive attitudes about self-harm. In turn, if women can develop self-
management skills for their self- harm in this way, it may promote better relationships between staff 
and self-harming women, may reduce relapse rates and, in the long-term, promote better care 
pathways. 
 
The research project will use a peer support model where long-term women prisoners will train the 
participants to use the MSC.  Current peer support in prisons includes Listeners schemes, Insiders, 
Peer Advisors and Health Trainers (25). Established peer support schemes rely upon confidentiality 
in prisons and have been well received. A recent systematic review (26) found that ‘peer support 

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services are acceptable within the prison environment and have a positive effect on recipients, 
practically and emotionally’ and that ‘consistent evidence from many, predominantly qualitative, 
studies, suggested that being a peer deliverer was also associated with positive effects’. 
 
Aims and Objectives: 
Primary Aim: To test feasibility and acceptability of medical skin camouflage for self-harm scarring in 
women prisoners. 
 
Objectives: To test the feasibility of long term prisoners delivering the modified skin camouflage 
intervention in a local women's prison with a sample of prisoners with self-harm scarring. To test the 
feasibility of the women completing the baseline and outcome measures and a diary of their self-
harm experiences during the research study. To evaluate acceptability of medical skin camouflage 
for women prisoners. To pilot collection of 3-month follow-up data from the women. To test the 
feasibility of collecting resource use data for the intervention using staff-completed proformas. 
 
Research questions: Is it feasible for long term prisoners to deliver medical skin camouflage to fellow 
prisoners with self-harm scarring in the prison environment? What are the barriers to recruitment, 
participation, retention of women? Is skin camouflage acceptable to recipients and stakeholders in 
prison settings? What women, service and research-centred outcomes should be adopted in a future 
Randomised Control Trial? 
 
Experimental Design and Methods: 
 
Research Design: Randomised, wait-list control. 
 
The feasibility pilot has four phases. Phase 1 and 2 were initially submitted and given ethical 
approval from North East – York REC REF: 16/NE/0030. Phase 1 and 2 have been completed and 
have informed the development of materials and conduct of phase 3 and 4. This application is for 
phase 3 and 4. 
 
Phase 1: Focus Groups (completed) 
Two focus groups were run in the prison. One with staff and one with women prisoners who had 
self-harmed. Following analysis, a second meeting was arranged with a smaller group of women 
prisoners to ask follow up questions which emerged from the analysis. The aim of the groups was to 

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establish the practicalities of using MSC in a women’s prisons, to discuss the outcome measures and 
any changes which would indicate an improvement in a woman’s well-being following MSC use, and 
to establish the women’s perspectives on the use of MSC in prison.  
 
Phase 2: Adaptation of MSC intervention (completed) 
 
Utilising the findings from Phase 1, we adapted the MSC for prison use. This involved developing a 
training manual and accompanying documents for the lifers and women participants, a procedure 
for consent and withdrawal from the research, and a process for women to access, store and use the 
MSC during the research. Standard operating procedures were also developed in collaboration with 
the prison for monitoring and managing incidents of self-harm which occur during the intervention 
phase.  
  
This application is for the final 2 stages of the research – Phase 3 and 4. For Phase 3 and 4 of the 
study the researchers will be escorted within the prison by Mark Craven or another prison staff 
member.  
 
Phase 3: 3-monthly, rolling programme of training and supporting 6 or more long-term women 
prisoners to deliver the intervention. Training materials for the long-term prisoners were developed 
in consultation with a service user researcher and women prisoners. We also consulted with Karina 
Lovell at the University of Manchester, who ran the Equip study which developed bespoke materials 
for training service users.  
 
Aim 
Test feasibility of training and supporting long term women prisoners to deliver the modified skin 
camouflage intervention to women prisoners with self-harm scarring. 
 
Methods 
Training sessions for long-term women prisoners will be run by members of the research team. 
Changing Faces have trained the project manager so she can train other people. Changing Faces is a 
third-sector organisation that trains volunteers to become MSC Practitioners. The project manager 
has trained the research assistant so she can also train the long-term prisoners. If clinical studies 
officers are also involved in the training they will be trained by the project manager. The training 
sessions for long-term prisoners will take place in a room in Safer Custody and a member of safer 

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custody staff will be present during all training sessions. The training sessions will take place during 
the core day and are considered by the prison to be purposeful activity, meaning that long-term 
prisoners will be allowed out of work to attend the training but will not lose out on any income. 
Training will be delivered following the exercises laid out in the Skin Camouflage Training Manual. 
Following the training the long-term prisoners will pass a record card to Mark Craven who will give 
the card to a nurse prescriber from the prison healthcare. The nurse will meet with the women and 
write a prescription for the MSC. Prescriptions will be ordered specifically for the research and will 
be invoiced to the research team. The prescriptions will take approximately 1 day and the nurse will 
alert the research team when the products are available. The research team will keep copies of the 
record card in case they need to provide the products, purchases online, to prisoners who have left 
the prison. 
 
All materials used in the training and phase 4, below, have been pre-approved by security at the 
prison to ensure that the women do not have access to materials which could be dangerous for 
themselves or others. For example, the research team will use plastic non-breakable mirrors 
approved by the prison so women who self-harm will not have access to glass. Access to the MSC 
products is not problematic as women already have access to regular make-up and brushes. 
 
Recruitment of long-term prisoners 
Women prisoners in the phase 1 focus groups informed us that they would feel most comfortable 
with other prisoners with experience of self-harm delivering the MSC intervention. They said that 
peer delivery was preferable to delivery by staff. The research team will therefore aim to recruit at 
least 6 long-term prisoners with experience of self-harm to deliver MSC. Consultation with prison 
staff suggested that we would not find it problematic to recruit this number of long-term prisoners 
with experience of self-harm. Prison staff informed us that these women are also likely to be 
orderlies in the prison or involved in listener’s schemes and assured us that these women are 
respected by peers and support other women already. This was also discussed by women prisoners 
in the phase 1 focus group; they identified and described occasions that they had been supported by 
long-term prisoners. Women in the focus group said they did not have concerns about trusting the 
long-term prisoners with confidential information. Women who volunteer to be trainers will be 
vetted by staff at the prison from Safer Custody and the Wings to ensure that they are safe and will 
not pose a risk to the women in the study and the researchers. They will be supervised by a member 
of the research team who will arrange weekly monitoring visits to ensure that the training is being 
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We will advertise for long-term prisoners (10 years or more left on their sentence) with experience 
of self-harm. Advertisement will be done via monthly Queensland meetings which involve 
representatives from each of the wings and houses. At these meetings we will distribute leaflets and 
posters advertising the research. Interested women will contact Mark Craven, the local collaborator, 
to express an interest in the research. Following vetting the long-term prisoners will be provide with 
an information sheet and offered the opportunity for the research team to visit and read through 
the sheet with them. Consent for the research will be agreed at least 24 hours after the information 
sheet has been read. The consent form will additionally ask for contact details of participants (email 
address/telephone number) for the research team to contact them, if they are released before their 
participation in the study ends. The consent form will also seek permission for the research team to 
contact the CRC/Probation service, should the details that the participant provide no longer be valid. 
 
Due to the prison reform and closure of Holloway women’s prison there is a large amount of 
movement in the women’s estate. The prison informed us that due to this they will be unable to put 
transfer holds on prisoners. We will be alerted by the prison if one of the long-term prisoners 
involved in the study is going to be moved. We will ensure that we train sufficient women to deliver 
the MSC; if we lose women to transfers we can recruit and train more if necessary. If we encounter 
difficulties with retention of long-term prisoners to deliver the MSC we can also train members of 
safer custody and the chaplaincy, but in the first instance we will train long-term prisoners as 
women with experience of self-harm had a strong preference for other prisoners with self-harm to 
deliver the intervention.   
 
The long-term prisoners will not be able to participate in the trial at the same time as their 
involvement as a skin camouflage practitioner, as their involvement in this capacity might confound 
the results. However, if they would like to use the skin camouflage make-up they will be provided 
with one prescription after the research has finished. 
 
Content of the training 
The training for long-term prisoners will have 3 sections; self-harm and working with women who 
self-harm, safeguarding participants (including training in confidentiality) and skin camouflage 
training. The training materials have been discussed with a service user research with experience of 
being in prison and self-harm in prison, prison staff and women prisoners with experience of self-
harm. The confidentiality section of the training will involve example cases which have been 

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informed by discussions with our service user researcher, the phase 1 focus groups, consultation 
with Louise Robinson, a forensic psychiatrist and consultation with Karina Lovell at the University of 
Manchester, who ran the Equip study which developed bespoke materials for training service users. 
 
The training materials come with an information pack containing the following: 
 
1. A record of the key learning points regarding working with vulnerable women and protecting 
themselves during the research 
2. An appointment checklist for the long-term prisoners which they can take to their 
appointments with the women as a reminder of the key steps in the MSC process 
3. A record card to be passed Mark Craven at the end of the long-term prisoner’s appointment 
with the research participant 
4. A ‘do’s and don’ts list to be given to the participants to remind them how to use the MSC 
during the research project  
5. A monitoring sheet, to be completed weekly and discussed with the researchers during 
supervision 
 
Support for long-term prisoners 
After the training the research team will provide regular weekly supervision for practical aspects of 
the product use and to check that the long-term women are comfortable delivering the training. If at 
any point during the study the long-term prisoners experience any emotional distress or find it 
triggering to teach other women to use the skin camouflage creams they will inform the research 
team or the local collaborator, Mark Craven, who will arrange the appropriate support within the 
prison. Long-term prisoners will be encouraged to report any accidental breaches of confidentiality 
following their sessions with the women so that the researchers can liaise with the prison to ensure 
that the women participants are protected from harm.  
 
Phase 3 Inclusion Criteria: Long term women prisoners. Women will have a long time left on their 
sentence e.g. 10 years or more. Following discussion with women prisoners in the phase one focus 
groups, we have agreed that the women will have personal experience of self-harm. The women will 
have passed the security vetting check which will be carried out by Safer Custody in association with 
prison officers to ensure that the researchers and participants are safe during the project. The 
women are likely to be people who already hold a position of responsibility in the prison e.g. 
Samaritan listeners or orderlies. 

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All participants will be aged 18 or older and able to give written, informed consent. Capacity to 
consent will be assessed by the experienced researchers. If capacity is in doubt the researchers will 
discuss individual participants with Safer Custody and Mental Health Care contacts in the prison, 
Mark Craven and Suzanne Cook. 
 
Phase 3 Exclusion Criteria: Women will be excluded if they have insufficient time left on their 
sentence, are deemed too high risk to others, are unable to give informed consent or have no direct 
experience of self-harm. 
 
Phase 4: Delivery of MSC and Evaluation of its Acceptability 
Quantitative aims: recruit and randomise 40 women to MSC for 6weeks or wait-list control (to 
receive MSC after the research has ended). Pilot the following: 
 
1. Women, service and research-centred outcomes from Phase I which include scales measuring 
psychosocial well-being, social functioning and everyday activities  
2. A diary to be completed during the 6-week study period which measures self-harm thoughts and 
actions, life events and, for the intervention group, the use of the medical skin camouflage. 
3. The collection of data on resource use using proformas for staff to collect information from the 
different prison databases, e.g. NOMIS    
4. Follow-up data collection, 3 months after the post intervention assessments.  
5. Data on recruitment, participation, retention and causes of drop-out.  
 
Qualitative aims: acceptability of MSC for stakeholders and the acceptability of training long term 
women prisoners to deliver the MSC training to participants 
 
Recruitment & Participants 
The advertisement strategies were informed by consultation with prison staff and women prisoners 
in phase 1. Prison staff suggested that we present the research at monthly Queensland meetings 
which involve representatives from all of the houses. We will also go in the evening to Bollingwood, 
the open house outside of the main prison gate, to discuss the project with women who are on open 
house. We will distribute leaflets and posters at the Queensland meetings and these will then be 
displayed around the prison. We will also run a drop-in showcase and awareness session for ½ day 
each week which will take place in safer custody, with a member of safer custody staff present. This 

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will enable women to find out more about the trial and ask us questions about participation. Women 
will inform our local collaborator, the head of safer custody, Mark Craven, if they are interested in 
taking part in the research. The women who volunteer will be vetted by staff at the prison from 
Safer Custody and the Wings to ensure that they are safe and will not pose a risk to the researchers. 
Following vetting the women will be provided with an information sheet and offered the 
opportunity for the research team to visit and read through the sheet with them. Consent for the 
research will be agreed at least 24 hours after the information sheet has been read.  
 
Prison staff informed us that we may identify some women who they do not know are self-harmers 
e.g. women who self-harm on their legs or torso. We will ensure in the meetings and showcase 
events that women know that by expressing their interest the prison will be aware of this and will 
know that they self-harm.  
 
If a woman is excluded by the prison on the grounds of safety a member of the safer custody team 
will speak to them to inform them that they will be unable to participate in the research. The safer 
custody team are experienced in working with women who self-harm and supporting women in the 
prison. They will be able to deal with this sensitively and arrange the appropriate support for the 
woman if anything is required.  
 
The sample size is 40 women prisoners overall. In the prison, there are ~40 active self-harming 
women prisoners per month (Nov 2013), of whom 25 have closed wounds, and 15-20 are likely to be 
eligible for camouflage per month. Our two recent consultations with stakeholders in the prison and 
the phase 1 focus group suggest interest in the intervention is high among women prisoners. 20 
women prisoners will be randomised to receive the 6-week intervention; the other 20 women 
prisoners will be wait-list controls and receive the intervention after study completion. In the focus 
group with women we explored how they would feel about being randomly allocated to intervention 
or wait-list control and the women said they would not mind as they would still get to use the 
products after the research. As piloted in WORSHIP II, we shall censor women by release-date to 
reduce attrition, and try to follow the few women moved before the end of 6-weeks. If a woman has 
left prison before the three-month follow-up we will ask the prison to send the follow up letter to 
the women in the community. The women will have consented to this approach at the start of the 
research. Follow up in the community will involve completion of the questionnaires via distance 
methods e.g. email, post or telephone interviews. If a wait-list control woman leaves the prison 

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before the MSC is provided they will be instructed to contact the research team and will be posted 
their bespoke skin matched creams and powders. 
 
Phase 4 Inclusion Criteria: Remand and sentenced women prisoners screened for date of release, 
with at least 6 weeks left on their sentence. The women will have passed the security vetting check 
which will be carried out by Safer Custody in association with prison officers to ensure that the 
researchers are safe during the project. The women will have self-harm scarring, with some closed 
wounds (to allow the MSC to be applied). 
 
All participants will be aged 18 or older and able to give written, informed consent. Consent forms 
will detail that participants consent to be followed up in the community if they have been released, 
and are happy to provide the research team with contact details of their choosing (email 
address/phone number) to facilitate this follow-up. Capacity to consent will be assessed by the 
experienced researchers. If capacity is in doubt the researchers will discuss individual participants 
with Safer Custody and Mental Health Care contacts in the prison, Mark Craven and Suzanne Cook. 
 
Phase 4 Exclusion Criteria: Women prisoners will be excluded if they only have open wounds, have 
less than 6 weeks on anticipated release date, are deemed too high risk to others, are not able to 
give informed consent to participate or have allergies to perfume and lanolin. 
 
Outcome Measures 
The baseline assessment will take place in safer custody with a member of the research team or a 
CSO. We have an agreement with the Clinical Research Network that there are CSOs who will be able 
to assist with data collection. The assessment will last around 1 hour. If, at any point during the 
assessment the woman becomes agitated or distressed, researcher will ask them if they would like 
to take a break or if they would like to complete the rest of the measures on another day. If the 
researcher has any concerns for the woman they will ask permission to alert Mark Craven who will 
ensure it is dealt with accordingly using the existing prison support systems.  
 
We will pilot the collection of a set of women, service and research-centred outcomes which were 
informed by Phase 1 focus groups: 
 
At baseline assessment we will work through the following scales with the women: DSHI, BSSI, BHS, 
BDI, EQ5D, SF12, WEMWBS, Rosenburg Self-esteem scale, DLQi, Zanarini PD Scale. See below for full 

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descriptions of the measures. The DLQi and Rosenberg Self-esteem Scale were added following focus 
group discussions on the psychological and interpersonal impact of scars and the effects on a 
woman’s self-esteem. 
 
With women’s permission, we will also access information on key clinical characteristics from 
CNomis, SystemOne (the prison electronic medical records) and from ACCT documentation. These 
systems will be accessed by prison staff unless the researchers are given permission to access them. 
Consent to access the systems and extract information will be sought for all women. Information on 
relevant personal history including past psychiatric history, domestic violence, sexual abuse and 
parental neglect history will be collected using a bespoke demographic and personal history 
questionnaire which was used successfully in the WORSHIP projects. This information will be 
collected to check whether the two randomised groups have similar backgrounds. 
 
During the 6-weeks skin camouflage intervention we will also ask each participant to complete a 
weekly diary. This idea was proposed by prison staff and women prisoners, some of who had 
completed a diary of self-harm thoughts and events in the past. The research team will collect the 
diary from the women at the end of the week. The diary will include any thoughts or acts of self-
harm that have occurred during the week. It will also list any life events that have impacted on a 
women’s self-harm. For the intervention group the diary will record their thoughts on the skin 
camouflage creams and powders. Women will also be able to note down any extra comments or 
thoughts from the week.  
 
We will also pilot the collection of resource use data. A series of resource use pro-formas will be 
created for each woman. Prison staff will extract data from each of the prison systems. The pro-
forma will be marked with the start date and end date (6 weeks apart) for the woman and resource 
use data will be extracted from Nomis, Officers logs, Business hub etc. Information on these systems 
will be redacted by prison staff before it can be passed on to the research team, e.g. to remove 
specific information about media-reported index offences. These systems will also be used to extract 
data on self-harm incidents which occurred during the 6-week intervention.  
 
At post-intervention assessment. The following scales will be completed at 6 week’s post-baseline 
and 3 months after the 6 weeks post-baseline assessment: DSHI, BSSI, BHS, BDI, EQ5D, SF12, 
WEMWBS, Rosenburg Self-esteem scale, DLQi, Zanarini PD Scale. Consent will be sought at baseline 
for women who have left prison before 3 months post-intervention to be followed up in the 

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community. Follow up will be via distance methods, with scale completion by email, post or over the 
telephone. 
 
Treatment Details: Skin camouflage clinics will be run by the long-term prisoners who have been 
trained to deliver the medical skin camouflage intervention. Clinics will be held during the core 
prison day and will not interfere with the women’s income. A member of safer custody staff will be 
present whilst the long-term prisoners are running the clinics. Each participant in the trial will be 
seen individually for one hour. During this appointment, the participant will receive information 
about the specially formulated MSC creams. This will include the long-term prisoner informing them 
about any potential allergens in the creams and ensuring the participant does not have any allergies 
which will prevent them from safely using the creams. Participants will also be told that the products 
do not include anything which would give them a high (at the recommendation of prison staff). The 
long-term prisoner will take the participant through the ethnic skin tone colour-matching process 
and will try small amounts of cream until they find a match. After this, they will apply the cream to a 
larger area and use special powders to set the cream and make sure it is waterproof. Throughout the 
appointment, an explanation of what they are doing will be given to participants and they will be 
able to watch the process in a plastic mirror. The participant will then be able to try applying the 
camouflage creams themselves. When they are happy with how it looks, the practitioner will 
complete a record form which will be given to Mark Craven to pass to healthcare. A nurse prescriber 
from healthcare will then arrange a meeting with each woman and will write her a prescription. 
Women will be told at the outset of the study that they will only be given the MSC for the duration 
of the study. The amount of camouflage cream used in each application will vary per woman 
depending on the extent of the scarring, but we anticipate that only one prescription will be 
required for the research.  
 
Women will be given the cream and powder and will be able to keep these in their houses. Each 
woman has access to a safe and will have the choice of locking the products away if they wish. The 
research team and prison staff will make it clear to the women that the products should not be 
traded or shared with other women. Feedback from women prisoners in the phase 1 focus group 
suggested that they would not trade the make-up and therefore the likelihood of trading is deemed 
to be low. Members of the research team will meet with women on a weekly basis to do spot checks 
on the products and to collect the weekly diary. Prison staff advised that spot checks would be a 
good idea and are done for in possession medications so women are used to these procedures. If the 

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research team has any concerns about the products being shared or not used in the correct way they 
will discuss this issue with Mark Craven, the local collaborator. 
 
Whilst using the products the women will be monitored, as usual, by Mark Craven and his team in 
safer custody. They will ensure participant safety and if any participant needs to be referred to a 
care team or for another form of support within the prison this will be dealt with by Mark Craven. 
Any events of self-harm which occur during the study period will be dealt with following ACCT 
procedures. Self-harm events will also be assessed to determine whether they are serious adverse 
events caused by participation in the research project. If so, the study has standard procedures 
which will be followed, as outlined in the standard operating procedures document. If a woman 
wishes to withdraw herself from the study she will inform Mark Craven and, with the woman’s 
permission, he will record the reason for withdrawal. Any women who withdraw from the study will 
be asked if they would like to meet with a member of the research team to talk about their 
participation in the project and why they wished to withdraw. It will be stressed that this is 
completely optional.  
 
As requested by prison healthcare staff, the research team will explain that there is no guaranteed 
access to the medical skin camouflage products after the research. The research team will write 
follow-up GP letters for all of the women in the trial which will detail their involvement in the study 
and list the names of the products that they were prescribed. This will help women to access the 
products when they return to the community.  
 
All women in the treatment and control group will be skin matched at baseline. This will ensure that 
any wait list control participants who leave prison before the 3 month follow up will be able to be 
posted skin matched products by the research team on request. 
 
Qualitative follow –up 
(1)We shall undertake qualitative interviews examining acceptability of the intervention for 
participants, prison health and other prison/disciplinary staff. Approximately 20 participants who 
received the treatment will be invited by the team to evaluate their experience of the intervention 
and explore their views on treatment accessibility i.e. applying MSC, how long it stays on for, its 
perceived usefulness, effects on everyday life and potential impact on how women feel about their 
scarring, mood, self-esteem and self-confidence.  

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(2)Members of the research team will undertake a focus group with 6-10 prison health and 
other/disciplinary staff who have had direct contact with participants who received the treatment 
intervention. Their views will be explored in relation to the treatments' acceptability and perceived 
effects on participants' well-being, quality of life and everyday functioning.  
(3)We shall undertake qualitative interviews examining acceptability of the training and being a 
practitioner in the prison. Six semi-structured interviews will be undertaken by the team to explore 
how acceptable the training was, how it was used with participants, mentoring/support from the 
research team and any benefits or difficulties working with participants. 
(4) The Research Assistant will undertake four focus groups with women prisoners to explore what 
wellbeing means to them. This will help to inform the development of a ‘wellbeing in prison’ 
measure which could be used in future projects.  
 We have developed detailed interview schedules and topic guides to facilitate the qualitative 
elements of the study which were informed by the phase 1 focus groups. 
 
Outcome measures: 
 
1. Warwick-Edinburgh Mental Well-Being Scale (WEMWBS): a 14-item scale of mental well-being 
covering subjective well-being and psychological functioning, in which all items are worded 
positively and address aspects of positive mental health. The scale is scored by summing responses 
to each item answered on a 1 to 5 Likert scale. The minimum scale score is 14 and the maximum 70. 
2. Becks Scale for Suicidal Ideation (BSSI): a 19-item instrument measuring intensity, duration and 
specificity of thoughts about committing suicide. The 19 items are rated on a three-point scale (0-2). 
3. Becks Depression Inventory (BDI): a 21-item scale measuring symptoms of depression. Items are 
rated on a 4-point scale (0-3) with severity of self-reported depression: 0-9 minimal; 10-16 mild; 17-
29 moderate and 30-63 severe. 
4. Beck Hopelessness Scale (BHS): a 20-item self-report inventory designed to measure three major 
aspects of hopelessness: feelings about future, loss of motivation and expectations. 
5. Deliberate Self-Harm Inventory (DSHI): a 17-item questionnaire giving history and frequency of 
self-harming behaviours. 
6. Prison-adapted Dermatology Quality of Life Index (DLQi): a 7-item questionnaire adapted from a 
validated 10 item scale that has been used in over 40 different skin conditions in over 80 countries. 
The DLQi is the most frequently used instrument in studies of randomised controlled trials in 
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7. Rosenberg Self-Esteem Scale: a 10-item Likert scale with items answered on a four-point scale – 
from strongly agree to strongly disagree. The scale measures self-esteem and has been used in 
prison research. 
6. Incidence and frequency of self-harm will be collected from participant’s prison records and the 
weekly diary. 
7. We shall explore acceptability/relevance of two generic preference-based health-related quality 
of life (HRQoL) measures: The EQ-5D-5L covers five domains of health (mobility, self-care, usual 
activities, pain/discomfort, anxiety/depression). This new version was developed due to concerns 
over the lack of sensitivity to change of the original EQ-5D-3L, and consists of five severity levels for 
each domain (no, slight, moderate, severe, and extreme problems) rather than the original three 
levels (no, moderate, or extreme problems). Participants' responses are converted to a single index 
utility value based upon preference weights obtained from a UK general population sample. 
SF-12 is a shortened version of the SF-35, consisting of twelve questions covering eight dimensions 
of health: physical functioning, role limitations - physical, bodily pain, general health, vitality, social 
functioning, role limitations - emotional, and mental health. A single index utility value is then 
obtained by applying published SF- 6D preference weights. 
8. Members of the prison staff will complete resource use proformas (based on the Secure Facilities 
Service sue Schedule) for all participants and the research team will record including time spent by 
Changing Faces training the researchers, time spent by trained prisoners delivering the intervention, 
and quantities of MSC products used and prescribed. Descriptive analysis will inform future trial 
design. 
9. Demographic and relevant personal history will be collected using a bespoke personal history 
questionnaire, previously used in a prison population in the WORSHIP projects. 
 
As per HMPPS rules and regulations, no incentives or payments can be offered to participants whilst 
they are residing in the prison. However, the research team will provide an incentive for released 
women to complete follow-up outcome measures in the community. This will take the form of a £20 
gift voucher, as well as reimbursement of travel expenses. This voucher will be given to compensate 
for their time and effort in coming to the appointment. 
 
Analyses 
 
(1) Feasibility and Acceptability: primarily qualitative (Phases I /4), but includes quantitative 
assessment of treatment attrition. Verbatim-transcription analysed using thematic content analysis.  

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(2) Quantitative data: Insufficient power for quantitative hypothesis testing means before and after 
treatment changes are descriptive including standard deviations and confidence intervals for 
outcome variables to inform sample size estimates for future RCT and assessment of feasibility of 
control group retention.  
(3) Feasibility of delivering and acceptability and relevance to the prison population of EQ-5D-5L, SF-
12 will be assessed through correlation between changes from baseline to follow-up of these and 
other piloted measures (WEMWBS, SOS-10, PANAS, BSSI, BDI, DSHI); and examination of completion 
rates. Descriptive analysis of HRQoL data will also be performed to inform the suitability of the 
measures for future clinical and economic evaluations of MSC in prison. 
The resource use proformas will be assessed through time taken to complete the forms, completion 
rates, and ability to obtain included resource-use categories. 
 
Survey 
We shall create, produce and conduct a short five-question paper survey, which will be offered to all 
prisoners within HMP Styal. This survey will ask questions related to prisoner wellbeing, and will be 
distributed through the prison’s internal mail system. Participants will not be obligated to fill out this 
survey Participants wishing to fill out this survey will be provided with a participant information 
sheet detailing what is involved in filling out this survey, and will need to provide written informed 
consent (by filling out a consent form) when returning the survey. 
 
Benefits of the study: 
The main benefits of this study can be divided into those for the prison and those for the wider 
NHS/public 
1. Women prisoners with self-harm scarring are likely to benefit from an increase in self-esteem, 
quality of life and recovery. We anticipate this will lead to greater participation in activities and 
rehabilitation programmes in the prison. Women in the phase 1 focus groups said that using the 
MSC may deter them from further self-harm and taking time to apply the make-up may enhance 
self-care and motivate them to live a healthier lifestyle. 
2. Long-term prisoners may find it rewarding to participate in research. In addition, research 
suggests that peer support can also improve the wellbeing of those who provide it.  
3. Our co-applicant reports preliminary data for the intervention in community self-harmers who 
show reduced stigma of scars from self-harm, reduced feelings of shame, decreased bullying, peer 
group rejection and isolation, increased engagement with peer groups, social activities. 

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4. Improving recovery provision in the prison environment importantly will decrease the likelihood 
of repeated self-harm behaviour and greater long term scarring. 
5. An intervention that reduces self-harm behaviour will also be likely to produce significant 
efficiency savings for prisons as the cost of managing women who self-harm (diverting officer 
resources to their care; reducing ACCT numbers) and their treatment will be reduced. 
6. Improving the portfolio with which prison staff can work with women prisoners who self-harm will 
improve relationships between prisoners who self-harm and staff caring for them. Staff will feel 
more empowered to support a pathway of recovery for women with self-harm scarring as the study 
will promote positive attitudes about self-harm in the prison and its management amongst staff. 
7. Modifying with stakeholders the various Scales and piloting their use in prison will benefit this 
population by validating their use in prison research. 
8. Assessing the acceptability and relevance of two generic preference-based health-related quality 
of life measures; the EQ-5D-5L and the SF-6D, to the prison population will inform the suitability of 
these measures for use in future clinical and economic evaluations in this setting. 
 
Wider NHS/public benefits: 
1. Upon release, when the women prisoners continue to be NHS service-users, women prisoners 
may become empowered to participate in work and social activities that they otherwise might avoid 
because of low self-esteem/ self-confidence and the stigma of scarring. 
2. The community pilot supports this notion as it suggests positive effects are associated with 
improved self-esteem, confidence, personal development and activities of daily living/functioning 
and reduced risk of mental illness or relapse. 
3. The risk in the longer term of unemployment and/or days off school/college and the economic 
burden associated with this in a vulnerable ex-offender population is considerable. Therefore, 
positive effects on this risk-burden are likely to be significant to the wider public. 
4. The study will also increase the evidence-base for using a women- and service-centred approach 
for developing medical skin camouflage services in the NHS more broadly as well as promoting 
development of a recovery model to be delivered to women services-users in other settings, such as 
secure services where self-harm management is a highly significant problem. 
5. Barriers and benefits to this recovery intervention identified in the study can be embedded in 
Safer Custody generic guidance (e.g. Prison Orders) through NOMS partnership working to improve 
healthcare delivery for self-harm recovery within women's prisons. 
 
Data Management 

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The research team has permission from the prison to take two digital recorders into the prison. After 
each session the researchers will download the interview audio files onto computers at the 
University of Manchester and delete them from the digital recorder. Data will be stored in an 
encrypted space on the University computers. This ensures that the data is held securely in one 
location. Moreover, the participants will be anonymous as their names will not be recorded on any 
of the audio files. Written consent forms and paper completed questionnaires will be removed 
straight to the University of Manchester. The questionnaires will be input into computers at the 
University of Manchester. All data on the computers will be stored in an encrypted space. All 
personal data will be stored at the University of Manchester in a locked filing cabinet and personal 
identifiable data will be stored separately from other research data and from participants' 
identifying codes. In the University of Manchester this will mean storage in the locked limited access 
corridor. 
 
Transcription of the audio files will be done by an approved external service that complies with data 
protection regulations, following advice from University data protection experts. The transcription 
company will provide an agreement that any audio files in their possession will be stored on an 
encrypted space. A formal contract will be drawn up between the University and the transcription 
company to ensure that the company complies with Data protection and confidentiality. 
 
Anonymised, encrypted research data may be transferred between the research team by email. 
Personal data will not be transferred electronically. Audio interview recordings and transcripts will 
be transferred electronically to an external transcription company. All files transferred electronically 
will be password protected and encrypted. Published quotations will be anonymised. 
 
The research team will be based in the Centre for Women's Mental Health at the University of 
Manchester and will abide by the Universities Confidentiality policy which forms part of the 
Information Security and Management Policy. Confidentiality clauses are included within staff 
contracts. All staff are aware of their responsibilities. The University policy satisfies the requirements 
of the Data Protection Act. 
 
The research team will have access to participants' personal data. This includes details such as 
demographic data, past psychiatric history and abuse history, sentence type, data on new self-harm 
incidents and any related life-events and data on resource use specific to self-harm. This information 
is necessary to assess the impact of Medical Skin Camouflage and to ensure that the two randomised 

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groups are comparable. Personal data will only be collected when there is written informed consent. 
Stored data will be anonymised with identifying information kept separately in a locked filing 
cabinet. Study data and material may be looked at by individuals from the University of Manchester, 
from regulatory authorities or from the NHS Trust, for monitoring and audit purposes, and this may 
well include personal information. 
 
Published quotations will be anonymised.  We will ensure that anonymised data across publications 
cannot be used in combination to identify individuals. 
 
In accordance with the guidelines of the University of Manchester the research data will be stored 
for at least 5 years after the last publication based on the data or for 10 years (whichever is greater). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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