Condition category
Mental and Behavioural Disorders
Date applied
19/12/2012
Date assigned
19/12/2012
Last edited
02/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The female prison population is growing at a much faster rate than men in prison. Recent government policy has identified women prisoners as having special health and service needs which are currently not met. Repeated self-harm (SH) (including suicide attempts) has become a considerable problem amongst women prisoners. It is associated with psychosocial problems, depression and increased risk of suicide, which is far greater in women prisoners than women in the community. Interpersonal conflicts are the commonest cause of SH in women and nearly 50% report histories of domestic violence, and around a third, previous sexual abuse, including one incident of rape in 1 in 20 women. Women prisoners also have high rates of mental illness. Managing SH is a significant call on scarce resources. Currently, no solution for women who SH in prison have been evaluated; none focuses explicitly on women's needs and no methodology for follow up has been developed. In this study, we developed and began evaluating a targeted intervention for SH using Psychodynamic Interpersonal Therapy (PIT) which focuses on resolving women's interpersonal and emotional difficulties which drive them to harm themselves. We have tested how feasible and acceptable it is to deliver PIT in a prison. We now want to find out how well PIT works for women prisoners with a recent history of repeat self-harm.

Who can participate?
Female prisoners aged 18-65 who have committed an act of self-harm in the previous month are eligible to participate in the study.

What does the study involve?
Participants will be randomly assigned to receive 4-8 sessions of PIT or control therapy (AC) after they have completed the initial assessments. We shall find out women's thoughts of suicide & SH, the number and severity of SH events at the start of the study, after therapy and 6 months later. We test out methods of following women for 6 months and test ways to collect information on use of prison resources resulting from women's SH.

What are the possible benefits and risks of participating?
This study may reduce suicidal thoughts and risk, and improve female prisoners' self-harm behaviour. Secondary benefits of this will be to improve safety and quality of life for female offenders, help the prison system improve care and treatment and provide women with equal opportunity to get SH therapies. The potential risk to women who participate in the PIT treatment group may be that if they explore their interpersonal problems perhaps for the first time this may bring out their negative past experiences and feelings, worsen their distress which could subsequently increase their self-harming behaviours. However, by engaging in a short-term therapy which focuses on women's distress, we hope to help women offenders self-manage their SH longer term.

Where is the study run from?
The study is run from Styal, Foston Hall and Newhall prisons, UK.

When is study starting and how long is it expected to run for?
The recruitment started in January 2013 and the study will run until June 2015, although we will be ending recruitment in September 2014.

Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR), UK.

Who is the main contact?
Dr Tammi Walker
tammi.walker@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tammi Walker

ORCID ID

Contact details

University of Manchester
Jean MacFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
-
tammi.walker@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11830

Study information

Scientific title

Women Offenders Repeat Self-Harm Intervention Pilot II

Acronym

WORSHIP II

Study hypothesis

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

Ethics approval

NRES Committee East of England - Essex, 25/06/2012 ref: 12/EE/0179

Study design

Randomised interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental Health Research Network - Suicide and self-harm

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Beck's Scale for Suicidal Ideation measured at baseline, post-therapy and at 6 month follow-up

Secondary outcome measures

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

Overall trial start date

17/12/2012

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

UK Sample Size: 140

Participant exclusion criteria

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 don't speak English
4. Women who are currently receiving a therapeutic intervention in prison

Recruitment start date

01/01/2013

Recruitment end date

01/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

NIHR - Research for Patient Benefit Programme (UK) ref: PB-PG-0610-22176

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes