A Pilot RCT Examining the Effectiveness of CMT for Healthcare Staff

A Pilot Randomised Control Trial Examining the Effectiveness of an Online Compassionate Mind Training for Healthcare Staff

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.

Study Overview

• Status: Recruiting
• Conditions: Staff Support
• Intervention / Treatment: Other: Staffcare Counselling; Other: Compassionate Mind Training

Detailed Description

Purpose The purpose of the study is to pilot and assess the effectiveness of an online compassionate based intervention for NHS staff accessing psychological assessment with the Occupational Health Service in one healthcare trust in Northern Ireland (BHSCT). This study aims to compare the effectiveness of this online intervention with usual treatment provided, Staffcare counselling.

Design Participants who meet the criteria and agree to take part will be randomly assigned to one of two groups: 1) CMT Intervention Group (IG) or 2) Treatment as Usual Group (TAUG). The random assignment will be done using online software.

Intervention Group (IG) The IG will follow an online programme developed and led by Dr. Chris Irons, a CMT expert. The programme is hosted on the Balanced Minds website and consists of four weekly sessions. Each session includes a 30-minute video, audio exercises, and reading materials. Participants must complete one session before moving to the next.

Treatment as Usual Group (TAUG) Participants in the TAUG will receive standard care as offered by the Occupational Health Service. This involves referral to Staffcare, for 6 weekly counselling sessions through the Employee Assistance Programme (EAP) following self-referral.

Questionnaires will be collected from both the IG and TAUG at the same four time points: pre intervention, mid intervention, post intervention and 4 week follow up. For the IG these time intervals for collecting measures will be at baseline, after 2 CMT sessions completed, after 4 CMT sessions completed and 4 week follow up. For the TAUG measures will be collected at baseline, after 3 counselling sessions have been completed, after 6 counselling sessions have been completed and 4 week follow up.

Recruitment Participants will be recruited from healthcare staff undergoing psychological assessments with the Occupational Health Service at BHSCT. Based on a statistical power analysis a minimum of 46 adults, aged 18-68, will be included in the study. Staff assessed as suitable for Treatment As Usual and meeting the study's inclusion criteria will receive an information sheet about the study during their assessment. If interested, their details will be added to a contact list by their clinician. The lead researcher will follow up via email to obtain written informed consent. Participants will generate a unique, non-identifiable ID code for anonymity, allowing data tracking across different timepoints. After random assignment to treatment group participants will be asked to complete baseline measures prior to commencing treatment.

RISK Ethical Risk: Participant information will remain confidential and will not be shared outside the research team. All data will be securely stored in an encrypted database within the Trust's Occupational Health Service. Once the study is completed, an anonymised version of the data will be sent to the chief investigator at Queen's University Belfast for analysis supervision.

Questionnaire Risk: Some survey questions about wellbeing and emotions could cause distress to participants. To mitigate this participants will be fully informed about the study before deciding to join. It will be clearly stated that participants can withdraw from the study at any time by contacting the research team. A debrief form with self-help and support service information will be provided at the end of the study.

Online Intervention Risk: While Compassion Focused Therapy and Compassionate Mind Training are considered safe, participants may be asked to reflect on emotions and engage in mindfulness exercises. As participants may already experience burnout or poor mental health they will be provided with support contact details for a member of the research team who is a Clinical Psychologist from the Occupational Health Service, who will be available throughout the intervention in case of any adverse effects.

Inclusion/Exclusion Eligibility for inclusion will require that participants are healthcare staff attending the occupational health service for psychological assessment in the BHSCT and are over the age of 18. Participants will need a good level of English to access and complete the intervention and TAU. Participants will require 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. Individuals who are currently participating in active psychological intervention will not be eligible to participate. Furthermore, individuals identified as being in active addiction or experiencing Serious Mental Illness, or if this is suspected by the staff member assessing the participant, they will not be eligible to participate. If an individual is actively suicidal and/or expressing suicidal ideation at the time of assessment they will not be eligible to participate. A CORE-10 score of 25 and above indicating severe psychological distress will also act as exclusion criteria as the intervention has shown to be most beneficial for mild to moderate psychological difficulties.

Consent Participants must provide fully informed, electronically written consent prior to joining the study. Healthcare staff who are assessed and deemed appropriate for TAU by Occupational Health staff and meet the inclusion criteria for the study will be provided with an information sheet during their assessment with details about the study. If they express an interest in taking part in the study and agree to being contacted by the lead researcher their details will be added to a spreadsheet by the Occupational Health staff member assessing them. The lead researcher will contact those who have expressed an interest in a follow up email to gather written informed consent to participate in the study. On the consent form, participants will be asked to generate a unique ID code which will be non-identifiable so all responses will be anonymous. This unique ID code will allow participants to be identified should they wish to withdraw from the study and to anonymously identify and match up participant data at different timepoints and allow the research team to track participant engagement with the intervention. Consent forms will be emailed along with the information sheets. Records of consent will be securely stored in the Trust's encrypted database, and participants will not be permitted to begin the intervention until consent is obtained. Following recruitment participants will be randomly assigned to 1) IG or 2) TAUG and the complete baseline measures.

Benefits This is a pilot study therefore benefit to participation cannot be guaranteed. Previous research has shown increases in self-compassion has a range of psychological benefits including reducing burnout and stress and improving mental health symptoms. It is hoped participants receiving the intervention will experience an improvement to their mental wellbeing. It is hoped to compare the effects of this treatment with treatment as usual provided by the Occupational Health Service.

Burdens The intervention will be provided through an online platform, enabling participants to access it at their convenience throughout the week. This approach minimises access barriers and alleviates the need for participants to travel for in-person sessions. The intervention consists of a 30-minute video each week over a four-week period and will include PDF materials. Participants will also be encouraged to practice mindfulness and imagery-based exercises during the week, though participation in these homework activities is not mandatory. Participants in the TAU group will be signposted to Staffcare counselling as routinely recommended by the service.

Confidentiality Participants' anonymity will be safeguarded throughout the study in accordance with BPS guidelines. Any identifiable information, such as email addresses, will remain confidential and stored in a password-protected database maintained by Occupational Health at Belfast Health and Social Care Trust. Upon completing a consent form, participants will be required to create and document a non-identifiable unique ID code to use when accessing questionnaires. The research team will maintain a record of each unique ID code within the password-protected database to track and manage participant information.

Conflict of Interest No conflicts of interest have been identified. On completion of the study participants will have the opportunity to request a summary of the results by emailing the research team to request a copy.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marylouise Mc Closkey; Phone Number: 07546774029; Email: mmccloskey29@qub.ac.uk
• Study Contact Backup: Name: David Curran; Phone Number: 028 90975652; Email: d.curran@qub.ac.uk

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • Recruiting
    • Queens University Belfast
    • Contact: Dr David Curran; Phone Number: 02890975445; Email: d.curran@qub.ac.uk
    • Contact: Professor Donncha Hanna
    • Sub-Investigator: Marylouise Mc Closkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• A CORE-10 score of 25 and above indicating severe psychological distress will also act as exclusion criteria as the intervention has shown to be most beneficial as a low intensity treatment option

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Staffcare Counselling	Other: Staffcare Counselling; 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.
Experimental: Compassionate Mind Training; 4 week online compassionate mind training	Other: Compassionate Mind Training; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Compassion Scale Short Form (SCS-SF)	The SCS-SF is a 12-item shortened version of the 26-item long form (SCS-26), designed to measure self-kindness vs self-judgement, common humanity vs isolation and mindfulness vs overidentification (Neff, 2003). Items are rated on a 5-point Likert scale ranging from 1 "almost never" to 5 "almost always" e.g. "When I fail at something that's important to me, I tend to feel alone in my failure".	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,	This 15 item scale measures fear of expressing kindness and compassion towards oneself e.g. "I fear that if I am too compassionate towards myself, bad things will happen". Items are rated using a 5-point Likert scale from 0 "don't agree at all" to 4 "completely agree".	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)	) is a 6 item scale that will be used at all timepoints for both the IG and TAUG to assess participant's experiences and perceptions of treatment. The CEQ is used to evaluate how credible the participant believes the treatment is and their expectations for improvement. The responses are aggregated to create an overall credibility score including subscales in confidence in treatment and expectation of success, with a higher score indicating greater perceived credibility and stronger treatment expectancies. The CEQ is useful in studies evaluating new treatments to understand how pre-treatment perceptions might influence treatment outcomes such as efficacy or adherence.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Clinical Outcomes in Routine Evaluation 10 (CORE-10)	The Clinical Outcomes in Routine Evaluation 10 (CORE-10) is a 10-item assessment measure for common presentations of psychological distress, and is designed to be generic, short, and easy-to-use in primary care mental health settings. Items are rated on a scale from 0 (not at all) to 4 (most or all the time), giving a total score range from 0 to 40. Higher scores indicate greater levels of distress, while lower scores reflect better emotional wellbeing. A score of 25 and above indicates severe psychological distress.	Eligibility screening pre study

Collaborators and Investigators

• Sponsor: Queen's University, Belfast

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: mental health; intervention; healthcare staff; pilot RCT; wellbeing; compassionate mind training
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: IRAS id 349638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To protect participant anonymity

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No