Clinical trial NCT06343818: Compassion Project: Developing an Empathy-Based Stress Intervention
Official title: The Compassion Project: Developing and Piloting an Intervention to Reduce Empathy-Based Stress on Adolescent Mental Health Wards
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Reduction of Empathy-Based Stress in Healthcare Staff
Keywords: Compassion Fatigue
Burnout
Secondary Trauma
Empathy-Based Stress
Staff wellbeing
Patient care
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Oxford Health NHS Foundation Trust
name: Central and North West London NHS Foundation Trust
First posted: 2024-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study uses a repeated AB design on two ward sites to assess feasibility, acceptability and usefulness of a novel intervention for empathy-based stress in staff, and to test feasibility of this study design. It is not assessing efficacy. The extended baseline measure is the control, there is no control group
Primary purpose: TREATMENT

Brief summary: Compassion is recognising that someone is suffering and wanting to help them. Compassion fatigue is a reduction in capacity to feel compassion for others. Secondary trauma is the experience of traumatic responses to hearing about someone else's trauma. Burnout is depersonalisation, emotional exhaustion, and feeling less good at one's job. Compassion fatigue, secondary trauma and burnout can all be referred to as empathy-based stress. This is a problem for healthcare staff and their patients.

Staff experiencing empathy-based stress deliver less high quality care, which can lead to serious consequences for patients. Empathy-based stress is also associated with staff sickness, which is bad for staff and costly to the United Kingdom's National Health Service (NHS).

Child and adolescent mental health (CAMHS) wards are busy, high-pressure environments where families and young people are often upset, resources are stretched, and staff are managing high levels of patient risk of self-harm or suicide.

The principal investigator has already reviewed research on empathy-based stress and interventions to prevent and/or reduce it in mental health ward staff. This evidence has been presented to CAMHS ward staff, managers, commissioners, patients and families and these stakeholders have co-designed an intervention for wards, to reduce empathy-based stress. The intervention aims to help staff to feel better and care better.

This pilot study aims to test and improve our intervention on two CAMHS wards, measuring how useful and well-liked it is, and how feasible it would be to use it and to test it on more wards. Staff on CAMHS wards will be offered a modular intervention including psychoeducation about empathy based stress and ways of combatting it, and workplace stressor and management toolkits. NHS CAMHS ward staff and patients will be asked to complete questionnaires and a subsample of staff will be asked to complete interviews about the process of the intervention.

Detailed description: A novel intervention aiming to reduce empathy-based stress in staff will be piloted sequentially on two adolescent mental health wards. After delivery on the first ward, feedback from post-intervention questionnaires and interviews with a subsample of staff will be used to modify the intervention before delivery on the second ward. The study aims to assess acceptability, usefulness and feasibility of the intervention, and feasibility of using these study methods (with a view to potentially trialing this intervention at a later date).

The intervention is called The Compassion Project, and it is a 6 month package which aims to target individual staff understanding and coping responses and also organisational practices. The Compassion Project uses a multi-level approach incorporating staff training, a range of resources and support for staff. These will include training materials (in audio, video and written forms), opportunities to discuss how current ward practices could be improved and to celebrate those which are working well. This intervention involves a modular structure encompassing individual, team and more organisational (through targeting management staff) levels of intervention. A working group of Compassion Champions from all levels of ward staff groups will work to embed the principles in the ward's practice. The intervention has been developed using information from a systematic literature review, Intervention Mapping and co-design with stakeholders.

The study uses a repeated AB design. Repeated baseline (A) and post-intervention (B) measures will be collected, then this will be repeated on the second ward. A mid-point measure will also be collected. The four measurement timepoints are -1 month, 0 months, 3 months and 6 months for staff to complete questionnaires. In addition, young people and parents/carers cared for by the ward at the time of intervention will be asked to complete two questionnaires at the point of discharge. Ward level measures (e.g. number of incidents) will allow context to be understood and also capture any changes over the course of the intervention, they will contribute to economic analyses also.

Eligibility criteria: Inclusion Criteria:

* Staff working on the 2 adolescent mental health ward sites at this time. All young people and parents/carers who are discharged during the time period of the intervention.

Exclusion Criteria:

* There are no exclusion criteria for staff. For young people who are inpatients on the ward and parents/carers of young people, an exclusion criteria would be if levels of English are such that questionnaires are inaccessible without reasonable adjustments and a supporting person is not available. We will strive to include all potential participants in the study if supporters are available to help an individual access the questionnaires.

Primary outcomes:
measure: Acceptability of intervention
timeFrame: Month 3 and Month 6
measure: Feasibility of intervention
timeFrame: Month 3 and Month 6
measure: Perceived usefulness of intervention
timeFrame: Month 3 and Month 6
measure: Feasibility of Study
timeFrame: Conducted in month 6
measure: Feasibility of gathering data on staff empathy-based stress using the Professional Quality of Life Scale at multiple timepoints
timeFrame: Month -1, 0, 3 and 6
Secondary outcomes:
measure: Feasibility of assessing health economics data using a Health-related Quality of Life questionnaire
timeFrame: Month -1, 0, 3 and 6
measure: Process measures to assess potential mechanisms of change
timeFrame: Month -1, 0, 3 and 6
measure: Feasibility of gathering young person and parent/carer data on compassionate care
timeFrame: Given at discharge throughout the 6 months of the intervention
measure: Feasibility of gathering young person and parent/carer data on experience of service
timeFrame: Given at discharge throughout the 6 months of the intervention
Other outcomes:
measure: Ward-level contextual factors
timeFrame: Month -1, 0, 3 and 6
Locations:
Study officials:
affiliation: University of Bath
name: Lucy Maddox, DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: