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Skin Camouflage for Women Prisoners With Self-Harm Scarring (COVER)

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ClinicalTrials.gov Identifier: NCT02638974
Recruitment Status : Completed
First Posted : December 23, 2015
Results First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Kerry Gutridge, University of Manchester

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 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.


Condition or disease Intervention/treatment Phase
Self Injurious Behaviour Other: Medical Skin Camouflage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Acceptability of Medical Skin Camouflage for Recovery of Women With Self-Harm Scarring in Prison
Actual Study Start Date : February 29, 2016
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars Self-Harm

Arm Intervention/treatment
Experimental: Medical Skin Camouflage
This arm will use medical skin camouflage for 6 weeks
Other: Medical Skin Camouflage
Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions

No Intervention: Wait List Control
This arm will receive medical skin camouflage at the end of the study



Primary Outcome Measures :
  1. Warwick-Edinburgh Mental Well-being Scale [ Time Frame: 6 weeks ]
    WEMWBS, Minimum: 14 Maximum: 70. Higher scores represent higher mental wellbeing


Secondary Outcome Measures :
  1. Becks Scale for Suicidal Ideation [ Time Frame: 6 weeks ]
    BSS MInimum: 0 Maximum: 28. The higher the score the greater the suicidal ideation.

  2. Becks Depression Inventory [ Time Frame: 6 weeks ]
    BDI-II Minimum: 0 Maximum: 63. 0-13 indicates minimal depression; 14-19 mild depression; 20-28 moderate depression and 29-63 severe depression

  3. Becks Hopelessness Scale [ Time Frame: 6 weeks ]
    BHS, Minimum: 0 Maximum: 20. 0-3 indicates No or minimal hopelessness; 4-8 is mild; 9-14 is moderate and 15+ is severe

  4. Rosenberg Self-Esteem Scale [ Time Frame: 6 weeks ]
    RSE Minimum: 0 Maximum: 30 Higher scores represent higher self-esteem

  5. Adapted-DQLI [ Time Frame: 6 weeks ]
    Adapted-DQLI Minimum: 0 Maximum: 24 The higher the score on the Dermatology Quality of Life Index the more impaired the quality of life



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Remand and sentenced women prisoners screened for date of release with at least 6 weeks left on their sentence
  • Self-harm scarring, with closed wounds (to allow the MSC to be applied).
  • Able to give written, informed consent.

Exclusion Criteria:

  • Women prisoners with open wounds
  • Less than 6 weeks on anticipated release date
  • Women with skin conditions and allergies
  • Women prisoners who lack the capacity to consent to the research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638974


Locations
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United Kingdom
Styal Prison
Wilmslow, Cheshire, United Kingdom, SK9 4HR
Sponsors and Collaborators
University of Manchester
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Kathryn Abel, PhD University of Manchester
  Study Documents (Full-Text)

Documents provided by Kerry Gutridge, University of Manchester:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kerry Gutridge, Project Manager, University of Manchester
ClinicalTrials.gov Identifier: NCT02638974    
Other Study ID Numbers: 15438
First Posted: December 23, 2015    Key Record Dates
Results First Posted: October 18, 2019
Last Update Posted: October 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Self-Injurious Behavior
Behavioral Symptoms