Clinical trial NCT04700878: A Randomized Controlled Evaluation of a Compassion-course for Healthcare Professionals
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Stress
Compassion
Occupational Health
Cognitive Behavioral Therapy
Lead sponsor: Linnaeus University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
name: Kalmar County Council
name: Sormland County Council, Sweden
name: Kronoberg County Council
First posted: 2021-01-08
Enrollment: 548
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample size was determined based on an expected between group effect size (between ICOP and ICB) of Cohen's d = 0.4 for the primary outcome at the five-week follow-up for the primary analysis for participants with SCQ scores of 45 and higher. To reach 80% power, the study need 100 participants in each active arm. Expecting 20% attrition, the investigators will include 120 participants. Thirty participants are required in the waitlist group with an expected between-group effect between the ICOP group and the waitlist of d = 0.8. Including the expected attrition, 36 participants will be required. Given the 200 participants and a power of 80%, the non-inferiority analysis will provide a minimal clinically important difference of roughly d = 0.35.

Participants with SCQ scores below 45 will be included for secondary analyses, thus expect to include 480 participants (ICOP and ICB), with an additional 72 participants in the waitlist group, for a total of 552.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change (from baseline) in Stress of conscience
timeFrame: 0, 5, 10 and 15 weeks and 6 months after baseline
Secondary outcomes:
measure: Change (from baseline) in Professional quality of life
timeFrame: 0, 5, 10 and 15 weeks and 6 months after baseline
measure: Change (from baseline) in Work-related stress
timeFrame: 0, 5, 10 and 15 weeks and 6 months after baseline
measure: Change (from baseline) in Self-compassion
timeFrame: 0, 5, 10 and 15 weeks and 6 months after baseline
Other outcomes:
measure: Sick leave
timeFrame: Number of periods of sick leave according the registry MIDAS from week 5 after baseline until week 52 after baseline.
measure: Satisfaction with treatment
timeFrame: Week 5 after baseline
Locations:
city: Växjö
country: Sweden
facility: Linnaeus University, Department of Psychology
state: Kronoberg
Study officials:
affiliation: Linnaeus University
name: Anna S Bratt, PhD
role: PRINCIPAL_INVESTIGATOR
References: