NCT06343818

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Aug 2024

Typical duration for not_applicable

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 Progress57%
Aug 2024Aug 2027

First Submitted

Initial submission to the registry

March 15, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

March 15, 2024

Last Update Submit

March 26, 2024

Conditions

Keywords

Compassion FatigueBurnoutSecondary TraumaEmpathy-Based StressStaff wellbeingPatient care

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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

    Month 3 and Month 6

  • Feasibility of Study

    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

    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 Outcomes (4)

  • Feasibility of assessing health economics data using a Health-related Quality of Life questionnaire

    Month -1, 0, 3 and 6

  • Process measures to assess potential mechanisms of change

    Month -1, 0, 3 and 6

  • Feasibility of gathering young person and parent/carer data on compassionate care

    Given at discharge throughout the 6 months of the intervention

  • Feasibility of gathering young person and parent/carer data on experience of service

    Given at discharge throughout the 6 months of the intervention

Other Outcomes (1)

  • Ward-level contextual factors

    Month -1, 0, 3 and 6

Study Arms (2)

Pilot Ward Site 1

EXPERIMENTAL

First ward site will pilot the intervention which will then be refined before delivery at second ward site

Other: The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff

Pilot Ward Site 2

EXPERIMENTAL

Second ward will pilot refined intervention

Other: The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff

Interventions

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.

Pilot Ward Site 1Pilot Ward Site 2

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Compassion FatigueBurnout, Psychological

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorOccupational StressStress, Psychological

Study Officials

  • Lucy Maddox, DClinPsy

    University of Bath

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy Maddox, DClinPsy

CONTACT

Paul Chadwick, DClinPsy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2024

First Posted

April 3, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

April 3, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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.