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ISRCTN
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ISRCTN18761534
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DOI
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10.1186/ISRCTN18761534
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Women Offenders Repeat Self-Harm Intervention Pilot II
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Scientific title
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Women Offenders Repeat Self-Harm Intervention Pilot II
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Acronym
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WORSHIP II
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Serial number at source
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11830
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Study hypothesis
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1. In the Psychodynamic Interpersonal Therapy (PIT) intervention group, levels of self-harm and suicidal ideation will be reduced further than those of the participants in the active control group.
2. By engaging female offenders in a short-term intervention which focusses on women's distress, we hope to help female offenders self-manage their self-harm in the longer term.
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11830
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Lay summary
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Lay summary under review 2
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Ethics approval
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NRES Committee East of England - Essex, 25 June 2012 ref: 12/EE/0179
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Study design
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Randomised interventional study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental Health Research Network - Suicide and self-harm
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Participants - inclusion criteria
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1. Women offenders aged over 18 years old
2. On an ACCT (Assessment, Care in Custody and Teamwork)
3. Self-harmed in the previous month
4. The female prisoners will also be screened for date of release or trial
5. If on remand they will need to have a minimum of 6 weeks to complete sessions
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Participants - exclusion criteria
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1. Women currently at serious risk of harm to others or suicide
2. Moderate to severe learning disability or without capacity to consent
3. Women who dont speak English
4. Women who are currently receiving a therapeutic intervention in prison
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Anticipated start date
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17/12/2012
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Anticipated end date
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01/06/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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UK Sample Size: 140
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Interventions
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Active control (AC)
AC comprises a basic control for women being taken out of their cells and having non prison staff company for a set period of time per week. Thus, women prisoners will be taken out of their cell once a week for 50 minutes by the Research Assistant and can engage in activities such as card games, reading magazines or practical topics (e.g. money management). No personal support/active listening is undertaken; women are told they cannot talk about emotional topics.
PIT, Psychodynamic Interpersonal Therapy (PIT) involves identifying and helping resolve interpersonal difficulties that exacerbate psychological distress. Specialist psychiatry trainees, from Manchester Mental Health & Social Care Trust will come into the prison to deliver this intervention. Sessions will be weekly and last for 50 minutes. Permission will be sought from participants for the sessions to be audio-recorded. Therapy will be monitored.
Followed up at 6 months
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Primary outcome measure(s)
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Beck's Scale for Suicidal Ideation measured at baseline, post-therapy and at 6 month follow-up
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Secondary outcome measure(s)
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1. Beck's Depression Inventory measured at baseline, post-therapy and at 6 month follow-up
2. Suicide Attempt Self-Injury Interview measured at baseline, post-therapy and at 6 month follow-up
3. The Prison Screening Questionnaire measured at baseline
4. Therapy satisfaction questionnaire measured post-therapy
5. Zanarini Rating Scale for Borderline Personality Disorder measured at baseline
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Sources of funding
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NIHR - Research for Patient Benefit Programme (UK) ref: PB-PG-0610-22176
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Trial website
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Publications
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Contact name
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Dr
Tammi
Walker
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Address
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University of Manchester
Jean MacFarlane Building
Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Email
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tammi.walker@manchester.ac.uk
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Sponsor
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University of Manchester (UK)
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Address
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Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Sponsor website:
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http://www.manchester.ac.uk/
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Date applied
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19/12/2012
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Last edited
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03/01/2013
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Date ISRCTN assigned
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19/12/2012
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