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

NCT ID: NCT04700878

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Psychological Stress Compassion Occupational Health Cognitive Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
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.

Study Groups

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Internet-based compassion course

Therapist guided Internet-compassion course for workrelated stress.

Group Type EXPERIMENTAL

General Internet-based cognitive behavioural course for stress management

Intervention Type BEHAVIORAL

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.

General internet-based CBT stress management course

Therapist guided Internet-cognitive behavioral (CBT) course for workrelated stress.

Group Type ACTIVE_COMPARATOR

General Internet-based cognitive behavioural course for stress management

Intervention Type BEHAVIORAL

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.

Waitlist

Waitlist for 10 weeks, and thereafter the general internet-based CBT management course.

Group Type OTHER

Internet-based compassion course for stress managemant

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Kalmar County Council

UNKNOWN

Sponsor Role collaborator

Sormland County Council, Sweden

OTHER

Sponsor Role collaborator

Kronoberg County Council

OTHER_GOV

Sponsor Role collaborator

Linnaeus University

OTHER

Sponsor Role lead

Responsible Party

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Anna Bratt

PhD, Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna S Bratt, PhD

Role: PRINCIPAL_INVESTIGATOR

Linnaeus University

Locations

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Linnaeus University, Department of Psychology

Vaxjo, Kronoberg County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Anna S Bratt, PhD

Role: CONTACT

+46706015998

Maude Johansson, Phd

Role: CONTACT

+46725941677

Facility Contacts

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Anna Bratt, PhD

Role: primary

+46706015998

Viktor Kaldo, Professor

Role: backup

Other Identifiers

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2020-05505

Identifier Type: -

Identifier Source: org_study_id

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