- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06343818
Compassion Project: Developing an Empathy-Based Stress Intervention
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).
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lucy Maddox, DClinPsy
- Phone Number: 01225 388388
- Email: lm2436@bath.ac.uk
Study Contact Backup
- Name: Paul Chadwick, DClinPsy
- Email: pdjc20@bath.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilot Ward Site 1
First ward site will pilot the intervention which will then be refined before delivery at second ward site
|
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.
|
Experimental: Pilot Ward Site 2
Second ward will pilot refined intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Month 3 and Month 6
|
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.
|
Month 3 and Month 6
|
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
|
Month 3 and Month 6
|
Feasibility of Study
Time Frame: Conducted in month 6
|
Red/Amber/Green analysis of ward recruitment
|
Conducted in month 6
|
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.
|
Month -1, 0, 3 and 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of assessing health economics data using a Health-related Quality of Life questionnaire
Time Frame: Month -1, 0, 3 and 6
|
European Quality of Life 5 Dimensions 5 Level Version (EQ5D-5L) Questionnaire
|
Month -1, 0, 3 and 6
|
Process measures to assess potential mechanisms of change
Time Frame: Month -1, 0, 3 and 6
|
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
|
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
|
A questionnaires relating to care will be administered to young people and parents/carers on discharge.
This is the Sinclair compassion Questionnaire Short Form
|
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
|
Two questionnaires relating to care will be administered to young people and parents/carers on discharge.
This is the Experience of Service Questionnaire.
|
Given at discharge throughout the 6 months of the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ward-level contextual factors
Time Frame: Month -1, 0, 3 and 6
|
Ward level contextual factors (e.g.
number of incidents) will allow context to be understood and also capture any changes over the course of the intervention.
Ward data will be gathered on ward caseload (ward occupancy), length of stay of patients, incidents on the ward, staff sickness, number of staff leaving.
These will be collected using a data sheet filled in by ward modern matrons using readily available data
|
Month -1, 0, 3 and 6
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lucy Maddox, DClinPsy, University of Bath
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NIHR301578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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