Reduction of Empathy-Based Stress in Healthcare StaffNCT06343818
Compassion Project: Developing an Empathy-Based Stress Intervention
A study testing The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff in people with Reduction of Empathy-Based Stress in Healthcare Staff, run by University of Bath.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reduction of Empathy-Based Stress in Healthcare Staff
- What is being tested?
- The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Paul Chadwick, DClinPsy contact
About this study
Official title: The Compassion Project: Developing and Piloting an Intervention to Reduce Empathy-Based Stress on Adolescent Mental Health Wards
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).
Read more
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.
Read the 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.
- Being tested
- The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff
- Keywords
- Compassion Fatigue, Burnout, Secondary Trauma, Empathy-Based Stress, Staff wellbeing, Patient care
- Medical subject headings
- Compassion Fatigue, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Compassion Project: Intervention to Reduce Empathy-Based Stress in StaffOther
Six month package of training and resources delivered to ward staff, including bite-sized audio, video and written materials. Face to face training will be provided weekly by a clinical psychologist. A staff group of 'compassion champions' will be responsible for embedding the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Ward Site 1 | Experimental | First ward site will pilot the intervention which will then be refined before delivery at second ward site Receives: Other: The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff |
| Pilot Ward Site 2 | Experimental | Second ward will pilot refined intervention Receives: Other: The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention
Acceptability of Intervention Measure (AIM), with a minimum score of 1 and a maximum score of 15, with higher scores indicating greater acceptability.
Measured: Month 3 and Month 6
Feasibility of intervention
Feasibility of Intervention Measure (FIM), with a minimum score of 1 and a maximum score of 20, with higher scores indicating greater perceived feasibility.
Measured: Month 3 and Month 6
Perceived usefulness of intervention
Two perceived usefulness questions rated on a 5 point Likert scale where 1 is not useful and 5 is extremely useful
Measured: Month 3 and Month 6
Feasibility of Study
Red/Amber/Green analysis of ward recruitment
Measured: Conducted in month 6
Feasibility of gathering data on staff empathy-based stress using the Professional Quality of Life Scale at multiple timepoints
Professional Quality of Life Scale (PROQUOL). Raw scores between 10 and 50 are presented for three subscales (1) Compassion Satisfaction, (2) Burnout and (3) Secondary Traumatic Stress. Higher scores on compassion satisfaction are positive, and higher scores on burnout or secondary traumatic stress relate to a poorer outcome.
Measured: Month -1, 0, 3 and 6
Secondary outcomes (4)
Feasibility of assessing health economics data using a Health-related Quality of Life questionnaire
European Quality of Life 5 Dimensions 5 Level Version (EQ5D-5L) Questionnaire
Measured: Month -1, 0, 3 and 6
Process measures to assess potential mechanisms of change
Knowledge about empathy-based stress questionnaire devised for the study (greater scores indicate greater knowledge) Mindful Attention and Awareness Scale (MAAS) (mean scores range from 1-6, with greater scores indicating greater mindfulness) Self-Compassion Scale (SCS) (minimum score is 1, maximum score is 60, with higher scores indicating more self compassion) Health and Safety Executive (HSE) Management Standards Questionnaire Questions about training Subsample of 15 qualitative interviews about process of the intervention
Measured: Month -1, 0, 3 and 6
Feasibility of gathering young person and parent/carer data on compassionate care
A questionnaires relating to care will be administered to young people and parents/carers on discharge. This is the Sinclair compassion Questionnaire Short Form
Measured: Given at discharge throughout the 6 months of the intervention
Feasibility of gathering young person and parent/carer data on experience of service
Two questionnaires relating to care will be administered to young people and parents/carers on discharge. This is the Experience of Service Questionnaire.
Measured: Given at discharge throughout the 6 months of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Empathy-Based Stress in Healthcare StaffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Oxford Health NHS Foundation Trust, Central and North West London NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Lucy Maddox, University of Bath
- Investigators
- Lucy Maddox, DClinPsy, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343818
- Sponsor's protocol ID
- NIHR301578
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Amalgamated data will be stored in a data repository and made available to researchers if they have a good reason to request it. All data will be anonymised and individual data will not be recognisable.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Compassion Project: Developing and Piloting an Intervention to Reduce Empathy-Based Stress on Adolescent Mental Health Wards
- ClinicalTrials.gov ID
- NCT06343818
- Acronym / sponsor ID
- NIHR301578
- Keywords
- Compassion Fatigue, Burnout, Secondary Trauma, Empathy-Based Stress, Staff wellbeing, Patient care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Oxford Health NHS Foundation Trust, Central and North West London NHS Foundation Trust
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Pilot Ward Site 1 | Experimental | Other: The Compassion Project: Intervention to Reduce Empathy-Based Stress in StaffFirst ward site will pilot the intervention which will then be refined before delivery at second ward site |
| Pilot Ward Site 2 | Experimental | Other: The Compassion Project: Intervention to Reduce Empathy-Based Stress in StaffSecond ward will pilot refined intervention |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Compassion Project: Intervention to Reduce Empathy-Based Stress in StaffSix month package of training and resources delivered to ward staff, including bite-sized audio, video and written materials. Face to face training will be provided weekly by a clinical psychologist. A staff group of 'compassion champions' will be responsible for embedding the intervention. | Other | Pilot Ward Site 1, Pilot Ward Site 2 |
Primary outcome
Acceptability of intervention
Time frame: Month 3 and Month 6
Acceptability of Intervention Measure (AIM), with a minimum score of 1 and a maximum score of 15, with higher scores indicating greater acceptability.
Feasibility of intervention
Time frame: Month 3 and Month 6
Feasibility of Intervention Measure (FIM), with a minimum score of 1 and a maximum score of 20, with higher scores indicating greater perceived feasibility.
Perceived usefulness of intervention
Time frame: Month 3 and Month 6
Two perceived usefulness questions rated on a 5 point Likert scale where 1 is not useful and 5 is extremely useful
Feasibility of Study
Time frame: Conducted in month 6
Red/Amber/Green analysis of ward recruitment
Feasibility of gathering data on staff empathy-based stress using the Professional Quality of Life Scale at multiple timepoints
Time frame: Month -1, 0, 3 and 6
Professional Quality of Life Scale (PROQUOL). Raw scores between 10 and 50 are presented for three subscales (1) Compassion Satisfaction, (2) Burnout and (3) Secondary Traumatic Stress. Higher scores on compassion satisfaction are positive, and higher scores on burnout or secondary traumatic stress relate to a poorer outcome.
4 secondary outcomes
Feasibility of assessing health economics data using a Health-related Quality of Life questionnaire
Time frame: Month -1, 0, 3 and 6
Process measures to assess potential mechanisms of change
Time frame: Month -1, 0, 3 and 6
Feasibility of gathering young person and parent/carer data on compassionate care
Time frame: Given at discharge throughout the 6 months of the intervention
Feasibility of gathering young person and parent/carer data on experience of service
Time frame: Given at discharge throughout the 6 months of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No. Amalgamated data will be stored in a data repository and made available to researchers if they have a good reason to request it. All data will be anonymised and individual data will not be recognisable.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Chadwick, DClinPsy contact
Lucy Maddox, DClinPsy principal investigator
University of Bath
Questions about this trial
What is this clinical trial studying?
A study testing The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff in people with Reduction of Empathy-Based Stress in Healthcare Staff, run by University of Bath.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucy Maddox, DClinPsy (01225 388388, lm2436@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention (time frame: Month 3 and Month 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.