A Pilot RCT Examining the Effectiveness of CMT for Healthcare Staff

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.