A Randomized Controlled Evaluation of a Compassion-course for Healthcare Professionals

Psychological Stress Clinical Trial

— ICOP  

Official title:

A Randomized Controlled Evaluation of a Compassion-course With the Aim of Reducing Stress of Conscience and Work-related Stress and Increase Levels of Professional Quality of Life and Self-compassion in Healthcare Professionals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04700878
• Other study ID #: 2020-05505
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: October 2023
• Source: Linnaeus University
• Contact: Anna S Bratt, PhD
• Phone: +46706015998
• Email: anna.bratt[@]lnu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to investigate whether an internet-based compassion course of five modules contributes to reducing stress of conscience and work-related stress, increase the experience of professional quality of life and self-compassion in healthcare professionals.

Description:

Reactions to severe stress is one of the most common causes of sick leave in Sweden. Previous research has shown that compassion interventions for staff can affect work-related stress by increased self-care, better self-awareness and an increased healthy attitude, however, Swedish studies on the subject are scarce.

Compassion is a motivation to reduce suffering in oneself and others characterized by a warm, understanding, and respectful attitude. In addition to beneficial effects for the staff, a compassion-oriented approach, has shown to improve the relationship between patient and staff, increase patient satisfaction with care and reduce patient anxiety and stress. As a result of the covid-19 pandemic, healthcare professionals have been exposed to difficult physical and mental work conditions that cause feelings of stress and inadequacy. In the long run, increased stress can cause fatigue and increased number of sick leaves. This can in turn contribute to increased stress for the staff who remain working and difficulties to recruit new staff, which make the situation worse. There is a lack of interventions for staff aimed at preventing stress-related health issues, enabling recovery and reduce mental suffering linked to a stressful work situations. The aim of this study is to find a method that help healthcare providers cope with stress of conscience in relation to stressful work situations, particularly during the current covid-19 pandemic. A five week internet-based compassion course of five modules will be conducted and evaluated with the aim of exploring whether the course contributes to reduce stress of conscience and work-related stress, and increases the levels of professional quality of life and self-compassion among healthcare professionals. The internet-based compassion course will be compared with: one group that is on a waiting list for ten weeks and then receives an internet-based general stress management course and one group that participate in the general stress management course.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 548
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

The inclusion criteria will be as follows: the participants work directly with patients full-time or part-time, score 45 points or higher on the primary outcome measure Stress of Conscience Questionnaire (SCQ), are proficient in Swedish, have the requisite time to attend a digital course, and accept the course's format.

The exclusion criteria include being partially or fully on sick leave due to stress.

All criteria are assessed on the basis of self-assessment forms of the participants, but in case of uncertainty, follow-up questions can be done by phone.

Related Conditions & MeSH terms

• Cognitive Behavioral Therapy
• Compassion
• Occupational Health
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Internet-based compassion course for stress managemant
A five week long, structured self-help program with weekly reports to, and feedback from a compassion-focused (CFT) therapist over the Internet. Includes traditional CFT-methods for stress-related problems.
• General Internet-based cognitive behavioural course for stress management
A five week long, structured self-help program with weekly reports to, and feedback from a cognitive-behavioral (CBT) therapist over the Internet. Includes traditional CBT-methods for stress-related problems.

Locations

Country	Name	City	State
Sweden	Linnaeus University, Department of Psychology	Växjö	Kronoberg

Sponsors (5)

Lead Sponsor	Collaborator
Linnaeus University	Kalmar County Council, Kronoberg County Council, Sormland County Council, Sweden, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sick leave	Sick leave from MIDAS registry, from the Swedish Social Insurance Agency	Number of periods of sick leave according the registry MIDAS from week 5 after baseline until week 52 after baseline.
Other	Satisfaction with treatment	Questions of satisfaction with the internet-based course and treatment credibility scale.	Week 5 after baseline
Primary	Change (from baseline) in Stress of conscience	Stress of Conscience Questionnaire (SCQ). The purpose of the SCQ is to estimate stress related to a troubled conscience. The questionnaire consists of nine items describing different healthcare situations, each made up of two parts, an A question and a B question. The A question concerns how frequently the subject estimates that the situation discussed arises in the workplace. This is assessed on a 6-point Likert scale, where 0 is 'Never' and 5 stands for 'Every day'. For each A question, there is a B question following it, in which the degree to which the conscience is troubled in the given situation is estimated on a 10 cm visual analogue scale. The visual analogue scale ranges from 0 = 'No, it gives me no troubled conscience at all' to 5 = 'Yes, it gives me a very troubled conscience'.	0, 5, 10 and 15 weeks and 6 months after baseline
Secondary	Change (from baseline) in Professional quality of life	Professional quality of life scale (PROQOL) Professional quality of life is the quality one feels in relation to their work as a helper. Both the positive and negative aspects of doing one's job influence ones professional quality of life. Professional quality of life incorporates two aspects, the positive (Compassion Satisfaction) and the negative (Compassion Fatigue). Compassion fatigue breaks into two parts. The first part concerns things such like exhaustion, frustration, anger and depression typical of burnout. Secondary Traumatic Stress is a negative feeling driven by fear and work-related trauma. Some trauma at work can be direct (primary) trauma. In other cases, work-related trauma be a combination of both primary and secondary trauma. The PROQOL consists of 30 questions assessed on a 5-point Likert scale, where 0 is 'Never' and 5 stands for 'Very often'.	0, 5, 10 and 15 weeks and 6 months after baseline
Secondary	Change (from baseline) in Work-related stress	Copenhagen Psychosocial Questionnaire (COPSOQ), assessing psychosocial factors at work, stress, and the well-being of employees.	0, 5, 10 and 15 weeks and 6 months after baseline
Secondary	Change (from baseline) in Self-compassion	Self-compassion scale (SCS) consists of 26 items, assessed on a 5-point Likert scale, where 0 is 'Almost never' to 5 for 'Almost always'.	0, 5, 10 and 15 weeks and 6 months after baseline