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Is a talking therapy, called psychodynamic interpersonal therapy, clinically and cost effective for women who self-harm in prison?

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10115835
Enrollment
264
Registered
2019-02-13
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-harm Mental and Behavioural Disorders

Interventions

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 (usu

Sponsors

Greater Manchester Mental Health NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 120 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Current secondary outcome measures as of 25/07/2019: 1. Demographic characteristics e.g. age, ethnicity, 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. Pre

Countries

England, United Kingdom

Contacts

Public ContactHeidi Tranter
heidi.tranter@manchester.ac.ukNone provided

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 27, 2026