NCT07411183

Brief Summary

The COVID-19 pandemic has highlighted the critical need for evidence-based interventions to support the psychological wellbeing of healthcare staff, particularly within Occupational Health settings. Recent research has documented significant mental health challenges among healthcare professionals, including high rates of burnout and stress. Fostering self-compassion has emerged as a key area for intervention. This study aims to pilot and assess the effectiveness of an online compassion-based intervention for healthcare staff, using a randomised Treatment As Usual (TAU) control group. The intervention will be grounded in Compassion Focused Therapy (CFT) and Compassionate Mind Training (CMT). CFT aims to shift focus from self-blame and shame to self-compassion, while CMT involves specific techniques to cultivate compassionate attitudes. The four-week online intervention, led by a CMT expert, will include mindfulness practices such as attention training, imagery, and behaviour-based exercises designed to foster an identity grounded in compassion. The sample will consist of healthcare professionals accessing Occupational Health service in Belfast Health and Social Care Trust (BHSCT) for psychological assessment. Participants who meet inclusion criteria will be randomly assigned to either the intervention group or the TAU control group. Questionnaires will be administered online at four time points: pre-intervention,mid intervention, post-intervention, and at one-month follow-up. The measures will assess mental health, burnout, self-compassion, fear of self-compassion and credibility and expectancy of treatment. Participants will be recruited through BHSCT Occupational Health Service and will be screened to meet inclusion criteria by the clinician completing psychological assessment. If the client agrees to be contacted by the researcher their name will be added to a study spreadsheet by their clinician and they will be contacted by the researcher to provide further information and obtain informed consent. Data will be collected electronically using Microsoft Forms and stored securely on an encrypted Trust-based database.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

September 23, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

October 13, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 13, 2026

Status Verified

October 1, 2025

Enrollment Period

11 months

First QC Date

September 23, 2025

Last Update Submit

February 6, 2026

Conditions

Keywords

compassionate mind traininghealthcare staffinterventionpilot RCTwellbeingmental health

Outcome Measures

Primary Outcomes (2)

  • The Professional Quality of Life (ProQOL) scale

    a self-report questionnaire designed by Stamm (2010) to measure the positive and negative aspects of working in helping professions. The ProQOL scale has three subscales: Compassion Satisfaction, Burnout and Secondary Traumatic Stress. Respondents rate how frequently they experience each item on a 5-point Likert scale from 1 "never" to 5 "very often". Respondents' scores on each subscale can provide insight into their overall professional quality of life. Higher scores on the Compassion Satisfaction subscale indicate greater satisfaction and fulfilment, while higher scores on the Burnout and Secondary Traumatic Stress subscales indicate greater levels of distress. Each scale has a minimum score of 10 and a maximum score of 50.

    Each group is measured at 4 timepoints: IG: Baseline, after 2 sessions of CMT, after 4 sessions of CMT, 4 weeks post treatment. TAUG: Baseline, after approx. 3 sessions of counselling, after approx. 6 sessions of counselling, 4 weeks post treatment.

  • The Depression, Anxiety and Stress Scale (DASS-21),

    a 21-item shortened version of the long-form DASS-42 (Lovibond \& Lovibond, 1995). The DASS-21 includes three, 7 item, self-report subscales designed to measure the emotional states of depression, anxiety and stress over the past week e.g. "I felt scared without any good reason", "I felt I had nothing to look forward to", "I found myself getting agitated". Items are rated on a 4-point Likert scale ranging from 0 "did not apply to me at all" to 3 "applied to me very much or most of the time". Scores need to be multiplied by 2 to calculate the full-scale score. Clinical cut offs range from 'Normal' to 'Extremely Severe'.

    Each group is measured at 4 timepoints: IG: Baseline, after 2 sessions of CMT, after 4 sessions of CMT, 4 weeks post treatment. TAUG: Baseline, after approx. 3 sessions of counselling, after approx. 6 sessions of counselling, 4 weeks post treatment.

Secondary Outcomes (3)

  • Self Compassion Scale Short Form (SCS-SF)

    Each group is measured at 4 timepoints: IG: Baseline, after 2 sessions of CMT, after 4 sessions of CMT, 4 weeks post treatment. TAUG: Baseline, after approx. 3 sessions of counselling, after approx. 6 sessions of counselling, 4 weeks post treatment.

  • Fears of Compassion Scale three: Expressing kindness and compassion towards yourself,

    Each group is measured at 4 timepoints: IG: Baseline, after 2 sessions of CMT, after 4 sessions of CMT, 4 weeks post treatment. TAUG: Baseline, after approx. 3 sessions of counselling, after approx. 6 sessions of counselling, 4 weeks post treatment.

  • The Credibility Expectancy Questionnaire (CEQ)

    Each group is measured at 4 timepoints: IG: Baseline, after 2 sessions of CMT, after 4 sessions of CMT, 4 weeks post treatment. TAUG: Baseline, after approx. 3 sessions of counselling, after approx. 6 sessions of counselling, 4 weeks post treatment.

Other Outcomes (1)

  • The Clinical Outcomes in Routine Evaluation 10 (CORE-10)

    Eligibility screening pre study

Study Arms (2)

Staffcare Counselling

ACTIVE COMPARATOR

Staffcare Counselling

Other: Staffcare Counselling

Compassionate Mind Training

EXPERIMENTAL

4 week online compassionate mind training

Other: Compassionate Mind Training

Interventions

The IG will receive an online intervention created, recorded and delivered by a member of the research team, Dr Chris Irons, founder of Balanced Minds and Board Member of the Compassionate Mind Foundation. The content of the intervention is based on the principles of CFT theory (Gilbert, 2009), CMT practices (Irons \& Beaumont, 2017) and research outcomes. The intervention is hosted on the Balanced Minds website by Dr Chris Irons and this will be freely accessible to participants. There is no cost to the research team for using this intervention and Dr Irons will be a named author for his participation. After participants provide consent, complete baseline measures and randomisation takes place, those randomised into the IG will receive an information leaflet detailing how to register on the Balanced Minds website using their provided email address. The intervention will consist of four weekly sessions, containing a 30-minute video, additional audio exercises and reading materials. Part

Compassionate Mind Training

Participants who are randomly allocated to the TAUG will be referred to an information leaflet providing usual care following assessment in the Occupational Health Service, as an appropriate intervention for their presenting difficulties as per the stepped care model. This involves referral to Staffcare for 6 weekly counselling sessions through the Employee Assistance Programme (EAP). This treatment is not affiliated with the Occupational Health Service.

Staffcare Counselling

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare staff attending the occupational health service for psychological assessment in the BHSCT
  • Over the age of 18
  • Good level of English to access and complete the intervention and TAU
  • Internet access on a suitable device to access the intervention and/or questionnaires
  • Individuals who are off on sickness absence will be eligible to participate.

You may not qualify if:

  • Individuals who are engaging in alternative active psychological intervention
  • Individuals identified as being in active addiction or experiencing Serious Mental Illness, or if this is suspected by the staff member assessing the participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queens University Belfast

Belfast, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Marylouise Mc Closkey

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 23, 2025

First Posted

February 13, 2026

Study Start

October 13, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 13, 2026

Record last verified: 2025-10

Locations