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

NCT04700878 | Recruiting DMC

• 1 other identifier: 2020-05505
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Compassion; Occupational Health; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change (from baseline) in Professional quality of life

  0, 5, 10 and 15 weeks and 6 months after baseline

• Change (from baseline) in Work-related stress

  0, 5, 10 and 15 weeks and 6 months after baseline

• Change (from baseline) in Self-compassion

  0, 5, 10 and 15 weeks and 6 months after baseline

Other Outcomes (2)

• Sick leave

  Number of periods of sick leave according the registry MIDAS from week 5 after baseline until week 52 after baseline.

• Satisfaction with treatment

  Week 5 after baseline

Study Arms (3)

Internet-based compassion course

EXPERIMENTAL

Therapist guided Internet-compassion course for workrelated stress.

Behavioral: General Internet-based cognitive behavioural course for stress management

General internet-based CBT stress management course

ACTIVE COMPARATOR

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

Behavioral: General Internet-based cognitive behavioural course for stress management

Waitlist

OTHER

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

Behavioral: Internet-based compassion course for stress managemant; Behavioral: General Internet-based cognitive behavioural course for stress management

Interventions

Internet-based compassion course for stress managemant 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.

Waitlist

General Internet-based cognitive behavioural course for stress management 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; Internet-based compassion course; Waitlist

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linnaeus University: lead
• Vastra Gotaland Region: collaborator
• Kalmar County Council: collaborator
• Sormland County Council, Sweden: collaborator
• Kronoberg County Council: collaborator

Study Sites (1)

Linnaeus University, Department of Psychology

Vaxjo, Kronoberg County, 35195, Sweden

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Anna S Bratt, PhD

  Linnaeus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Bratt, PhD

CONTACT

+46706015998; anna.bratt@lnu.se

Maude Johansson, Phd

CONTACT

+46725941677; maude.johansson@lnu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)