Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02638974 |
| Other study ID # |
15438 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 29, 2016 |
| Est. completion date |
June 1, 2018 |
Study information
| Verified date |
September 2019 |
| Source |
University of Manchester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Women prisoners are more likely to commit suicide or self-harm than women in the community or
male prisoners.
Healthcare services have improved how they manage self-harm in the community and prisons.
However, there has been little focus on the recovery of people with self-harm scars. Medical
skin camouflage (MSC) is a British National Formulary-listed topical cream designed to cover
skin conditions. Research on MSC has focused on its use with non-self-harm marks e.g. burns.
The evidence from this research suggests that the cream helps women feel better and do more
activities. There is little/no evidence about the effects of the preparation for women who
self-harm and for prisoners.
This research was funded by the National Institute for Health Research Research for Patient
Benefit Programme. In the research the investigators will examine whether it is possible and
practical to use MSC in prison. The investigators will ask women prisoners and staff what
they think about the cream. The research has four parts. In the first part the investigators
will run focus groups with women prisoners and prison staff to find out the best way to
deliver the MSC intervention and how to measure its effects. In the second part the
investigators will design a programme for delivering the MSC. The investigators will then
train 6-10 long-term prisoners to become skin camouflage practitioners. The final part will
involve a small randomised controlled trial with 40 women prisoners; 20 will be allocated to
the intervention group and will use the MSC for 6 weeks. The investigators will measure their
mood, thoughts of self-harm and wellbeing before and after they use MSC. The investigators
will compare these results with 20 women who have not used MSC (waitlist control group). All
women taking part will be placed at random into the control or the treatment group. The
control group will receive the MSC after the research has ended.
Potential benefits of this study may be an increase in self-esteem and quality of life for
the women prisoners. As women recover they may be less likely to self-harm.
Description:
The study aims to establish the feasibility and acceptability of the use of medical skin
camouflage for self-harm scarring in a women's prison. The investigators are interested in
the use of medical skin camouflage by women who are recovering from self-harm. The research
location is a Closed Category prison for female adults and young offenders in England. The
study will involve adult women prisoners (over 18) and staff at the prison.
Medical Skin Camouflage uses specialised creams/powders to disguise skin conditions or
scarring with the intention of normalising the appearance of the skin. Studies which have
examined the use of medical skin camouflage for dermatological diseases or burns have
reported significant psychological benefits and social benefits. Preliminary findings from
co-applicant Dr Sandeep Ranote's work, with young people who self-harm in the community,
indicate that the use of medical skin camouflage can lead to increased well-being, confidence
and ability to partake in social activities. Currently there is no evidence on the use of MSC
for self-harm scarring in prisons.
The research design is intended to provide information necessary to decide whether it is
feasible and acceptable to conduct a full scale randomised controlled trial of MSC in a
women's prison. The four phases of the research are as follows:
Phase 1: Focus groups in prison. Interested prisoners and staff will be provided with an
information sheet about phase 1 of the project and will have up to 48 hours to decide whether
they want to take part in this phase of the research. After consent the investigators will
conduct 2 focus groups with women prisoners (including current self-harmers) and prison staff
(6-10 in each group; 12-20 in total). The focus groups are designed to achieve two aims: to
ensure that appropriate outcome measures are used in the phase four pilot trial; and to
explore any barriers to the delivery of medical skin camouflage in a prison environment. The
focus groups will last 60-90 minutes.
In the groups the investigators shall explore the following:
1. Any potential problems with the introduction of MSC.
2. How training long-term prisoners as camouflage practitioners will be undertaken (see
phase 3).
3. With women prisoners: the investigators will discuss how scarring affects mood,
self-esteem, self-confidence, resilience, and how others perceive them. These questions
will be designed to assess how best to collate information about how scarring affects
prisoner's lives and their mental health informing which outcomes should be measured in
phase 4. Part of this consultation will involve asking them to help us adapt standard
measures of wellbeing (such as WEMWES) so they are appropriate for a prison environment.
4. The investigators will also discuss the use of Assessment, Care in Custody and Teamwork
data (ACCT) and Inpatient Mental Health Records during the pilot trial. Prisoners who
are at risk of self-harm are assessed by the prison Safer Custody team who follow the
ACCT procedures which include recording incidents of self-harm.
The focus groups will be recorded, transcribed and checked for accuracy. The data will be
analysed by members of the research team. To mitigate against possible researcher bias, an
independent experienced researcher will review the findings.
During phase 1 members of the research team will also be trained to become medical skin
camouflage practitioners. This training will be delivered by Changing Faces, a third-sector
organisation. Training is accredited by the Royal College of Nursing (2012). This training
will be done in preparation for phase 3.
Phase 2: Guidance protocol
Using the findings from phase 1, the investigators will refine the study processes and
procedures ready for the next two phases. This will involve:
1. The production of a guidance protocol for the use of medical skin camouflage in prisons.
The protocol will focus on practical aspects of where, when and how treatment is
delivered, who applies it; how it is applied; how it is prescribed, and storage of
prescribed products.
2. Finalising how the training of lifers will be delivered and supported (in preparation
for phase 3). This includes adapting the Changing Faces training manual so it is
suitable for use with women prisoners.
3. Finalising the eligibility criteria for phase 4, e.g. how assessment will be made of
self-harm scar wounds and how women will be referred to the trial.
4. Finalising the outcome measures to be used in phase 4.
5. If necessary, refining our standard operating procedures for monitoring and managing any
incidents of self-harm during the intervention.
Phase 3: Training lifers This phase of the research involves the training of long-term
prisons (lifers) to deliver the medical skin camouflage intervention to the women prisoners
in phase 4. By training lifers to deliver the intervention the investigators will ensure that
women prisoners are integral to the delivery of camouflage to other women offenders. Not only
does this genuinely include stakeholders in research, but it also builds sustainable capacity
within the prison and is likely to increase self-efficacy/self-worth of those women.
In phase 3 the MSC trained research team members will implement a rolling programme of
training and support for 6 or more long-term women prisoners so they are able to deliver the
MSC intervention. During this phase and in phase 4, the research team will provide regular
mentoring and advice on practical aspects of the product use. The women lifers will receive
ongoing supportive liaison throughout the project from members of the research team.. The
project manager will liaise with the prison lifers to ensure fidelity to the guidance
protocol.
Phase 4 Phase 4 is a small scale randomised wait list control pilot. A sample of 40 women
prisoners with self-harm scarring at the prison will be recruited; 20 participants will be
randomised to receive the 6 week camouflage intervention; 20 participants will become
wait-list controls and receive the intervention after completion of the 6-week trial. The
trial participants will be remand and sentenced women prisoners screened for date of release,
with at least 6 weeks left on their sentence and self-harm scarring, with closed wounds (to
allow the MSC to be applied).
Eligible female prisoners will be identified by the prison, for example using information
known by the Safer Custody team. Once identified the research team will provide the potential
participants with an information sheet. Following earlier research in prisons, the
investigators envisage that potential participants will be allocated a research number
assuring anonymity from the research team. This process will allow the researchers to send
out participant information sheets to relevant potential participants and allow participants
to make an informed decision about participation prior to identifying themselves to
researchers. Potential participants will be given 24-48 hours to decide whether they want to
consent to involvement. The Clinical Research Network will assist the research assistant with
the recruitment to the pilot trial.
A member of the research team will interview all the women at the start of the trial
collecting information on the following:
1. Basic demographics (Bespoke Personal History Questionnaire)
2. History of self-harm (Deliberate Self-harm Inventory)
3. Mood (Beck Depression Inventory II, Beck Scale for Suicidal Ideation, Beck Hopelessness
Scale)
4. Psychosocial well-being (Warwick Edinburgh Mental Wellbeing Scale) and self-esteem
(Rosenberg Self-esteem Scale)
5. Health-related quality of life (SF-12 and EQ5D) and quality of life related to scarring
(Prison-adapted Dermatology Quality of Life Index)
6. Zanarini Rating Scale for Borderline Personality Disorder With women's permission the
research team will record key clinical characteristics from CNomis, SystemOne (the
prison electronic medical records) and from ACCT documentation.
The MSC treatment will be provided for 6 weeks. The trained long-term prisoners will run
regular 1 hour appointments for women in the intervention group. During this appointment, the
participant will receive information about the specially formulated MSC creams. The lifers
will take them through the 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 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 prescription form that will be processed by a
nurse prescriber. The prescription will provide them with one cream and one powder which we
anticipate will last for 3-6 months. During the intervention the research team will record
data on new self-harm incidents and related life-events (using ACCT data and Inpatient mental
health records). All participants will also be asked to complete a weekly diary to record
their self-harm experiences (thoughts and acts) during the trial.
At the end of the 6 weeks the research team will meet with participants to collect post
intervention data. Initial post-intervention testing is at 6 weeks as the average sentence
length for women in the prison. Six weeks post-intervention the investigators will repeat
baseline measures apart from the demographic questionnaire. A final follow-up will be piloted
at 3-months post-baseline. Recruitment, participation, retention and causes of drop-out will
also be collected.
Post-intervention the investigators will conduct qualitative interviews with the following
groups:
1. All women who received the intervention will be invited to participate in an interview
to explore their experience of the intervention and its acceptability. The investigators
will explore the participants views on treatment accessibility and potential impact on
how women feel about their scarring, mood, self-esteem and self-confidence.
2. All women in the waitlist control group will be invited to participate in an interview
to explore their experiences of being randomised to the control group and participating
in the research.
3. 6-10 prison health and other staff who have direct contact with the participants will
take part in a focus group. This will explore their views in relation to the treatments'
acceptability and perceived effects on participants' well-being, quality of life and
everyday functioning.
4. Interviews will be conducted with the lifers who delivered the intervention exploring
how acceptable the training was, how MSC was used with the participants, feedback on the
mentoring and support and any benefits or difficulties working with participants.
During the course of the research the investigators will also be exploring the best way to
calculate the resource use associated with providing MSC in prisons. The investigators shall
develop a bespoke resource use questionnaire to pilot the collection of resource use data
concerning the delivery of the intervention, including time spent by Changing Faces training
the research team, time spent by trained prisoners delivering the intervention, and
quantities of MSC products used and prescribed. Descriptive analysis of this data will inform
future trial design.
The Secure Facilities Service Use Schedule (SF-SUS) will be used to collect other relevant
resource-use at 3month follow-up: contact with personal, Safer custody and general prison
officers, and staff from mental health team; time on one-to-one observation, specialist
mental health units; recording observations and care plans. SF-SUS records individual-level
data on service use within secure facilities and external services for economic evaluation.
