Clinical Trial: Skin Camouflage for Women Prisoners With Self-Harm Scarring

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Feasibility and Acceptability of Medical Skin Camouflage for Recovery of Women With Self-Harm Scarring in Prison

Brief 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 prisoners and staff what they think about the cream. The research has four parts. In the first part the investigators will talk to groups of people from the prison about the best way to use the cream and how to measure its effects. In the second part the investigators will design a programme for the MSC application. The investigators will then train prisoners to apply the cream. The final part will involve 20 people using MSC for six 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 people who have not used MSC (control group). All women taking part will be placed at random into the control or the treatment group. The control group will receive the cream after the research has ended.

Potential benefits of this study may be an increase in s

Detailed Summary:

The research 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 cream to disguise scars 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 women 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. 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 us
Sponsor: University of Manchester

Current Primary Outcome: Change in Eq-5d-5l from baseline at 3 months [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Warwick-Edinburgh Mental Well-being Scale from baseline at 6 weeks [ Time Frame: 6 weeks ]
• Change in Becks Scale fo Suicidal Ideation from baseline at 6 weeks [ Time Frame: 6 weeks ]
• Change in Becks Depression Inventory from baseline at 6 weeks [ Time Frame: 6 weeks ]
• Change in Becks Hopelessness Scale from baseline at 6 weeks [ Time Frame: 6 weeks ]
• Change in Deliberate Self Harm Inventory from baseline at 6 weeks [ Time Frame: 6 weeks ]
• Change in SF-12 from baseline at 3 months [ Time Frame: 3 months ]

Original Secondary Outcome: Same as current

Information By: University of Manchester

Dates:
Date Received: November 18, 2015
Date Started: January 2016
Date Completion: January 2018
Last Updated: May 12, 2016
Last Verified: May 2016