NCT06477380

Brief Summary

Experiences of abuse, neglect, domestic violence, severe bullying and community violence in childhood are very common among people who use mental health services. These often have serious and long lasting impacts on people's mental health.When a person decides to disclose or talk about these traumatic experiences it can help healing. However, mental health staff often lack confidence and organisational support to ask about childhood traumatic events and struggle to know how to respond to disclosures or how best to offer follow up support. A research method called experience-based co-design will be used to find different ways of supporting staff to safely have conversations about childhood trauma with service users. Experience-based co-design involves;

  • A training package for community mental health team staff
  • A toolkit for clinicians to help them to safely talk about childhood trauma with service users.
  • Changes to the physical environment to make it feel safer
  • A reflective practice group for staff Anticipated impacts: For service users: Improved experience of disclosing ACEs; improved access to trauma treatment; improved therapeutic relationships; improved mental health outcomes. For staff: Improved confidence and competence to sensitively explore ACEs; improved compassion; greater job satisfaction

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jun 2024Aug 2026

Study Start

First participant enrolled

June 1, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

June 21, 2024

Last Update Submit

June 21, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Intervention acceptability and feasibility

    Interview and focus groups will be carried out with staff and service users to explore the acceptability and feasibility of the intervention

    6 months post intervention

  • Therapeutic relationship

    The STAR-C measure will be used to assess clinicians therapeutic relationships with their patients pre and post intervention (https://pubmed.ncbi.nlm.nih.gov/17094819/)

    baseline, 3 months and 6 months

  • Professional Quality of Life (ProQOL)

    The ProQOL will be used to measure clinicians compassion satisfaction and compassion fatigue (inc. burn out and indirect trauma)

    baseline, 3 months and 6 months

Study Arms (1)

Intervention arm

EXPERIMENTAL

Community mental health team staff will receive the intervention (training, toolkit, reflective supervision group and changes to the physical environment) over a period of six months.

Behavioral: ACCEPT intervention

Interventions

* Training package (1 day) * A toolkit/manual for clinicians to guide them through the disclosure process * Trauma-informed changes to the physical environment * Monthly trauma-focussed reflective group for care co-ordinators

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Service users/survivors participants
  • be age 18 or over
  • have capacity to consent in research
  • self-reported lived experience of ACEs - defined by the ACE-IQ (WHO, 2018)
  • past or current service user of NHS community mental health services in England
  • Clinical staff participants:
  • NHS practitioners who currently or previously worked as a front line allied health professional in a community mental health team
  • employed by Sussex Partnership Foundation Trust
  • have capacity to consent to participate in research
  • be aged 18 or over

You may not qualify if:

  • Service user/survivor participants
  • \- People who have never received support from NHS community mental health services
  • Clinicians
  • Staff who have never worked in NHS community mental health services
  • Medics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sussex Partnership Foundation Trust

Worthing, West Sussex, BN11 1HS, United Kingdom

Location

IoPPN, Kings College London

London, SE5 8AF, United Kingdom

Location

Central Study Contacts

Jessica K Sears, MSc

CONTACT

Alan Simpson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: This is a small size feasibility study. There is no control arm and the aim of the study is to assess the feasibility and acceptability of the intervention in a community mental health setting. Findings from this study will be used to optimise the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 27, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Due to the sensitivity of the research topic and ethical concerns it is not deemed appropriate to share individual participant data

Locations