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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04700878
Acronym
ICOP
Enrollment
548
Registered
2021-01-08
Start date
2021-02-01
Completion date
2027-12-31
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Behavioral Therapy, Compassion, Occupational Health, Psychological Stress

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.

Interventions

BEHAVIORALInternet-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.

BEHAVIORALGeneral 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.

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Kalmar County Council
CollaboratorUNKNOWN
Sormland County Council, Sweden
CollaboratorOTHER
Kronoberg County Council
CollaboratorOTHER_GOV
Linnaeus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

This study is a single-blind randomized trial where eligible participants will informed about that they will be assigned to either of two different stress-management courses or to waitlist, but they are unaware of which particular conditions. The waitlist group (ten weeks waitlist and thereafter either compassion- or cognitive behavioural courses) will receive thorough information about the two different courses and thereafter rate how attractive they find each course. Then they get to choose which course they want to attend to.

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change (from baseline) in Stress of conscience0, 5, 10 and 15 weeks and 6 months after baselineStress 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'.

Secondary

MeasureTime frameDescription
Change (from baseline) in Professional quality of life0, 5, 10 and 15 weeks and 6 months after baselineProfessional 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'.
Change (from baseline) in Work-related stress0, 5, 10 and 15 weeks and 6 months after baselineCopenhagen Psychosocial Questionnaire (COPSOQ), assessing psychosocial factors at work, stress, and the well-being of employees.
Change (from baseline) in Self-compassion0, 5, 10 and 15 weeks and 6 months after baselineSelf-compassion scale (SCS) consists of 26 items, assessed on a 5-point Likert scale, where 0 is 'Almost never' to 5 for 'Almost always'.

Other

MeasureTime frameDescription
Sick leaveNumber of periods of sick leave according the registry MIDAS from week 5 after baseline until week 52 after baseline.Sick leave from MIDAS registry, from the Swedish Social Insurance Agency
Satisfaction with treatmentWeek 5 after baselineQuestions of satisfaction with the internet-based course and treatment credibility scale.

Countries

Sweden

Contacts

Primary ContactAnna S Bratt, PhD
anna.bratt@lnu.se+46706015998
Backup ContactMaude Johansson, Phd
maude.johansson@lnu.se+46725941677

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026