Skin Camouflage for Women Prisoners With Self-Harm Scarring (COVER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02638974|
Recruitment Status : Completed
First Posted : December 23, 2015
Results First Posted : October 18, 2019
Last Update Posted : October 18, 2019
|First Submitted Date ICMJE||November 18, 2015|
|First Posted Date ICMJE||December 23, 2015|
|Results First Submitted Date ICMJE||May 30, 2019|
|Results First Posted Date ICMJE||October 18, 2019|
|Last Update Posted Date||October 18, 2019|
|Actual Study Start Date ICMJE||February 29, 2016|
|Actual Primary Completion Date||June 1, 2018 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Warwick-Edinburgh Mental Well-being Scale [ Time Frame: 6 weeks ]
WEMWBS, Minimum: 14 Maximum: 70. Higher scores represent higher mental wellbeing
|Original Primary Outcome Measures ICMJE
||Change in Eq-5d-5l from baseline at 3 months [ Time Frame: 3 months ]
Measures quality of life
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Skin Camouflage for Women Prisoners With Self-Harm Scarring|
|Official Title ICMJE||Feasibility and Acceptability of Medical Skin Camouflage for Recovery of Women With Self-Harm Scarring in Prison|
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.
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:
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:
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:
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:
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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
|Condition ICMJE||Self Injurious Behaviour|
|Intervention ICMJE||Other: Medical Skin Camouflage
Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
|Study Arms ICMJE||
|Publications *||Mitchell H, Abel KM, Dunlop BJ, Walker T, Ranote S, Robinson L, Edgar F, Millington T, Meacock R, Shaw J, Gutridge K. Acceptability and feasibility pilot randomised controlled trial of medical skin camouflage for recovery of women prisoners with self-harm scarring (COVER): the study protocol. BMJ Open. 2019 Jan 17;9(1):e021891. doi: 10.1136/bmjopen-2018-021891.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||June 1, 2018|
|Actual Primary Completion Date||June 1, 2018 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT02638974|
|Other Study ID Numbers ICMJE||15438|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||
|Responsible Party||Kerry Gutridge, University of Manchester|
|Study Sponsor ICMJE||University of Manchester|
|Collaborators ICMJE||National Institute for Health Research, United Kingdom|
|PRS Account||University of Manchester|
|Verification Date||September 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP