Condition category
Mental and Behavioural Disorders
Date applied
11/02/2019
Date assigned
13/02/2019
Last edited
20/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Self-harm is an important, growing problem in prisons, especially for women. Only 5% of prisoners are women but they carry out over a quarter of prison self-harm. There are many reasons for self-harm, such as managing distress, trying to control emotions and self-punishment. People who self-harm are more likely to attempt suicide than those who do not. Although self-harm rates are high, there are currently no treatments which have been properly tested in prisons. This study aims to see if a talking therapy developed with women and prison staff for prisoners who self-harm, Psychodynamic Interpersonal Therapy (PIT), will lead to less self-harm and be value for money for the NHS and improve the lives of women who self-harm in prison.

Who can participate?
Women who are in prison for at least 8 weeks, who have self-harmed in the last month and who have been on an ‘ACCT’ in the last month can take part. ACCT stands for Assessment Care in Custody and Teamwork and is a prison-based system used to monitor people who are at risk of self-harm.

What does the study involve?
Participants are allocated by chance to the treatment group or to a control group. Women who receive the treatment undertake 4-8 50-minute sessions of psychodynamic interpersonal therapy (PIT). In PIT, people discuss their feelings, their relationships and how their past has influenced them. The aim is to help them find new ways to manage emotions and relate to others. Women in the control group receive any treatments which are currently on offer in the prison.

What are the possible benefits and risks of participating?
The PIT intervention may help reduce self-harm thoughts and feelings and may lead to a decrease in self-harm behaviour. We cannot promise that participants will receive PIT or that the research will help individual participants but the information from the research might help treat other women prisoners who self-harm in the future. Talking about self-harm may be upsetting.

Where is the study run from?
1. HMP Styal (UK)
2. HMP New Hall (UK)
3. HMP Bronzefield (UK)
4. HMP Send (UK)
5. HMP Downview (UK)
6. HMP Foston Hall (UK)
7. HMP Eastwood Park (UK)
8. HMP Askham Grange (UK)
9. HMP Drake Hall (UK)

When is the study starting and how long is it expected to run for?
August 2018 to February 2023

Who is funding the study?
National Institute for Health Research Health Technology Assessment programme (UK)

Who is the main contact?
Dr Kerry Gutridge
kerry.gutridge@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kerry Gutridge

ORCID ID

http://orcid.org/0000-0001-9705-9102

Contact details

3rd Floor
Jean McFarlane Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306-7931 or +44 (0)751 891 3418
kerry.gutridge@manchester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

38762

Study information

Scientific title

Women Offenders Repeat Self-Harm Intervention Pragmatic Trial (WORSHIP III)

Acronym

WORSHIP III Version 1

Study hypothesis

Psychodynamic interpersonal therapy is clinically and cost effective for women who self-harm in prison.

Ethics approval

South East Scotland Research Ethics Committee 02, Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, Tel: +44 (0)131 536 9000, Email: Joyce.Clearie@nhslothian.scot.nhs.uk, 23/10/2018, ref: 18/SS/0118

Study design

Randomised; Interventional; Design type: Treatment, Complementary Therapy, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Self-harm

Intervention

Randomisation will be at the individual level by block randomisation with randomly varying block sizes, stratified by prison. Participants are randomised to the PIT treatment or the control group (usual care, not having PIT) and outcomes are compared. Therapy will be delivered by supervised trainee Clinical/Forensic Psychologists and Psychiatrists. Psychodynamic Interpersonal Therapy (PIT) will last for 4-8, 50-minute sessions, depending on women's preferences. The duration of the intervention is 4-8 session over 8 weeks. Follow up is 8 weeks post baseline and 12 weeks post baseline. The trialists are interested in whether PIT reduces self-harm incidents and its effects on other outcomes such as self-esteem and wellbeing. They are also interested in whether PIT reduces the financial costs associated with self-harm.

Intervention type

Other

Phase

Drug names

Primary outcome measure

A composite of self-harm incidents derived from self-report, medical databases (SystmOne) and prison databases or paper records (NOMIS; F213 forms, ACCT folders, self-harm incidents logs) checked for double entry; Timepoint(s): 8 weeks

Secondary outcome measures

Current secondary outcome measures as of 25/07/2019:
1. Demographic characteristics e.g. age, ethinicity, number of children and location of the children, educational background, past experience of the care system, abuse, neglect and domestic violence, measured using the bespoke WORSHIP III demographic and personal history questionnaire at baseline
2. Any undiagnosed mental illness, assessed using the Prison Screening Questionnaire (PriSnQuest) at baseline
3. Mental health history including past diagnoses, assessed using the bespoke Mental Health History (MHHQ) questionnaire at baseline
4. Self-harm history assessed using a bespoke Self-harm History questionnaire at baseline
5. Presence of borderline personality disorder, assessed using MacLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) questionnaire at baseline
6. Depression assessed using the Beck Depression Inventory questionnaire at baseline, 8 weeks and 12 weeks
7. Hopelessness assessed using the Beck Hopelessness Scale questionnaire at baseline, 8 weeks and 12 weeks
8. Self-esteem assessed using the Rosenberg Self-Esteem Scale questionnaire at baseline, 8 weeks and 12 weeks
9. General well-being assessed using the Warwick-Edinburgh Mental Well-Being Scale questionnaire at baseline, 8 weeks and 12 weeks

Previous secondary outcome measures:
1. Demographic characteristics e.g. age, ethinicity, number of children and location of the children, educational background, past experience of the care system, abuse, neglect and domestic violence, measured using the bespoke WORSHIP III demographic and personal history questionnaire at baseline
2. Any undiagnosed mental illness, assessed using the Prison Screening Questionnaire (PriSnQuest) at baseline
3. Mental health history including past diagnoses, assessed using the bespoke Mental Health History (MHHQ) questionnaire at baseline
4. Self-harm history assessed using the Adapted Deliberate Self-Harm Inventory (DSHI) questionnaire at baseline
5. Presence of borderline personality disorder, assessed using Zanarini Borderline Personality Disorder (ZBPD) questionnaire at baseline
6. Depression assessed using the Beck Depression Inventory questionnaire at baseline, 8 weeks and 12 weeks
7. Hopelessness assessed using the Beck Hopelessness Scale questionnaire at baseline, 8 weeks and 12 weeks
8. Self-esteem assessed using the Rosenberg Self-Esteem Scale questionnaire at baseline, 8 weeks and 12 weeks
9. General well-being assessed using the Warwick-Edinburgh Mental Well-Being Scale questionnaire at baseline, 8 weeks and 12 weeks

Overall trial start date

01/08/2018

Overall trial end date

28/02/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 25/07/2019:
For women participating in the randomised controlled trial and qualitative follow-up (as piloted in WORSHIP I and II):
1. The participant is a remand or sentenced woman in prison who is on an ACCT currently or has been on an ACCT in the last month. ACCT refers to the Assessment Care in Custody and Teamwork process which is used in prisons for self-harm monitoring and management. The ACCT process is started when women are at risk and often experiencing thoughts of self-harm. It is designed to target people who are at risk of self-harm repetition.
2. The participant is a woman in prison who has self-harmed in the last month.
3. The participant is 18 years or over. The intervention has been piloted with adults as women under 18 may have different needs.
4. The participant has been screened for date of release or trial and has a minimum of 8 weeks left in prison, at baseline, to complete the intervention sessions

For staff participating in the qualitative follow-up:
Have worked with women involved in the intervention

Previous inclusion criteria:
For women participating in the randomised controlled trial and qualitative follow-up (as piloted in WORSHIP I and II):
1. Remand and sentenced women in prison who are on an ACCT currently or have been on an ACCT in the last month. ACCT refers to the Assessment Care in Custody and Teamwork process which is used in prisons for self-harm monitoring and management. The ACCT process is started when women are at risk and often experiencing thoughts of self-harm. It is designed to target people who are at risk of self-harm repetition
2. Women who have recently self-harmed in the last month
3. Women will be 18 years or over. The intervention has been piloted with adults as women under 18 may have different needs.
4. Women will be screened for date of release or trial and will need to be in the prison for a minimum of 8 weeks to complete the intervention sessions.
5. Women currently involved in another psychological intervention in the prison establishment which has aims that overlap with PIT, e.g. it is designed to address their distress or self-harm via a talking therapy approach.

For staff participating in the qualitative follow-up:
Have worked with women involved in the intervention

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 348; UK Sample Size: 348

Participant exclusion criteria

Current exclusion criteria as of 25/07/2019:
For women participating in the randomised controlled trial and qualitative follow up:
1. The participant is currently involved in another psychological intervention in the prison establishment which has aims that overlap with PIT, e.g. it is designed to address their distress or self-harm via a talking therapy approach or they are booked to start an overlapping therapy during the 12-week study period
2. The participant lacks capacity to consent to research participation. This assessment will be made by experienced researchers in collaboration with prison staff and healthcare staff and will be based on the principles behind the Mental Capacity Act (2005).
3. The participant is too distressed/unwell to participate in research. This decision will be based on consultation with Safer Custody/healthcare staff. For example, women who are at a very high risk of suicide may be excluded as they will be too distressed to engage effectively with therapy.
4. The participant currently poses a high risk to the researchers or the therapists. This criterion is only for people who pose an imminent risk of violence which would mean that the researchers/therapists are in danger of physical harm. People will be assessed based on their current risk rather than their past behaviours. Assessment will be made by the Safer Custody and OMU team in consultation with the researchers and mental health in-reach. Once the risk has subsided women may be eligible to participate if they fit the other criteria.

For staff participating in the qualitative follow-up:
Staff with no experience working with women involved in the intervention

Previous exclusion criteria:
For women participating in the randomised controlled trial and qualitative follow up:
1. Women who lack capacity to consent to research participation will be excluded from the research. This assessment will be made by experienced researchers in collaboration with prison staff and healthcare staff and will be based on the principles behind the Mental Capacity Act (2005).
2. Women who are too distressed/unwell to participate in research will also be excluded. This decision will be based on consultation with Safer Custody/healthcare staff. For example, women who are at a very high risk of suicide may be excluded as they will be too distressed to engage effectively with therapy.
3. Women who have less than 8 weeks left in prison will also be excluded as they will be unable to complete the entire course of treatment.
4. Women who currently pose a high risk to the researchers or the therapists will also be excluded from the research. This criterion is only for people who pose an imminent risk of violence which would mean that the researchers/therapists are in danger of physical harm. People will be assessed based on their current risk rather than their past behaviours. Assessment will be made by the Safer Custody team in consultation with the researchers and mental health in-reach. Once the risk has subsided women may be eligible to participate if they fit the other criteria.
5. Women will be excluded if they are already involved in another psychological intervention within the prison establishment that has aims which overlap with PIT, e.g. it is designed to address their distress or self-harm via a talking therapy approach.

For staff participating in the qualitative follow-up:
Staff with no experience working with women involved in the intervention

Recruitment start date

01/09/2019

Recruitment end date

01/05/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

HMP Styal
Wilmslow
SK9 4HR
United Kingdom

Trial participating centre

HMP New Hall
Dial Wood Flockton
Wakefield
WF4 4XX
United Kingdom

Trial participating centre

HMP Bronzefield
Woodthorpe Road
Ashford
TW15 3JZ
United Kingdom

Trial participating centre

HMP Send
Ripley Road
Woking
GU23 7LJ
United Kingdom

Trial participating centre

HMP Downview
Sutton Lane
Sutton
SM2 5PD
United Kingdom

Trial participating centre

HMP Foston Hall
Foston
Derby
DE65 5DN
United Kingdom

Trial participating centre

HMP Eastwood Park
Falfield
Wotton-under-Edge
GL12 8DB
United Kingdom

Trial participating centre

HMP Askham Grange
Askham Richard
York
YO23 3FT
United Kingdom

Trial participating centre

HMP Drake Hall
Eccleshall
ST21 6LQ
United Kingdom

Sponsor information

Organisation

Greater Manchester Mental Health NHS Foundation Trust

Sponsor details

Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
+44 (0)161 358 1689
Annya.Sekula@gmmh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/111/51

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol will be available when published. Dissemination will happen throughout the grant and in the year after the grant ends.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

28/02/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/04/2020: Due to current public health guidance, recruitment for this study has been paused. 25/07/2019: The following changes were made to the trial record: 1. The secondary outcome measures, inclusion and exclusion criteria were updated. 2. The recruitment start date was changed from 01/05/2019 to 01/09/2019.