The Efficacy of the iWork.COMP Among Health Care Professionals

NCT07018089 | Not Yet Recruiting

• 2 other identifiers: 101137244HORIZON-HLTH-2023-CARE-04
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

According to the literature, the prevalence of anxiety, depression, and/or burnout symptoms among healthcare workers is high. There are several factors than can, directly or indirectly, be related to these symptoms, being the leadership styles one of them. Toxic leadership, as a form of malicious leadership, has been shown to negatively impact the mental health and wellbeing of the workforce, through the adoption of dysfunctional behaviour and/or the presence of deviant personality traits (psychopathic, Machiavellianism, narcissistic) in leaders. Despite its relevance, there is an absence of studies on the efficacy of intervention programs aimed to reduce the impact of toxic leadership styles in the workplace, namely among health care professionals. Compassion Focused Therapy (CFT) is considered an effective therapeutic approach for the rehabilitation of individuals with several psychopathological symptoms/disorders (e.g., anxiety, stress, burnout, and deviant personality traits) and for the establishment of healthy relationships with friends, family, and coworkers. In the workplace, CFT-based interventions have been shown to promote employees' wellbeing, through the reduction of stress and burnout symptoms and improvement of healthy and compassionate interpersonal relationships. It is thus mandatory to develop and test cost-effectiveness CFT-based intervention programs able to mitigate the impact of toxic leadership styles in the workforce, promoting compassionate workplaces in health care systems. To fulfil this gap, this clinical trial intends to develop and preliminarily test the efficacy of a short-term and low-time consuming internet delivery CFT-based intervention (iWork.COMP) specifically designed to mitigate the impact of toxic leadership styles through the development of compassionate motivation among health care professionals. Following a Randomized Controlled Trial, with 200 participants allocated to either a treatment group (TG) or a waiting-list control group (WLCG), it is hypothesized that the iWork.COMP will reduce the impact of toxic leadership styles, deviant traits and burnout symptoms among the TG when compared with the WLCG. Moreover, we expect that the iWork.COMP will promote wellbeing and a compassionate motivation among the TG when compared with the WLCG.

Conditions

Toxic Leadership Styles

Keywords

Health care workers; Surgical pathway; Clinical Trial; Compassion Focused Therapy; iWork.COMP

Outcome Measures

Primary Outcomes (1)

• The Toxic Leadership Scale

  Toxic Leadership: The Toxic Leadership Scale (TLS) is a 15-item instrument that aims to measure the five toxic leadership dimensions proposed by Schmidt: Abusive Supervision (i.e., the demonstration of hostile verbal and nonverbal behaviors), Authoritarian Leadership (i.e., an absolute control over his/her subordinates and all decision making), Narcissism (i.e., a grandiose and self-centered style), Self-promotion (i.e., a presentation of the self as a smart and capable person), and Unpredictability. Items are rated on a six-point Likert-type scale ranging from 1 (Strongly Disagree) to 6 (Strongly Agree). Higher total scores indicate higher levels of toxic leadership style. The TLS will be used in the present study to assess employees' perception of their direct leader's toxic leadership styles. Psychometric studies of the TLS have demonstrated a very good internal consistency (α ranging from .87 to .93).

  Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)

Secondary Outcomes (4)

• The Dirty Dozen

  Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)

• The Burnout Assessment Tool

  Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)

• The Daniels's Five-Factor Measure

  Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)

• The Fears of Compassion Scales

  Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)

Study Arms (2)

Treatment Group

EXPERIMENTAL

The TG will receive iWork.COMP. The iWork.COMP is an 8-week internet delivery intervention based on CFT, aimed at reducing the impact of toxic leadership styles through the development of a compassionate motivation. After this period, participants will have access to the SOS-Button tool. Participants in this group will be assessed in four assessment-points (4-weeks intervals; approximately 10 minutes per assessment point): baseline, middle of the intervention, post-treatment, four-week follow-up.

Behavioral: iWork.Comp

Waiting List Control Group

NO INTERVENTION

This group will not receive any intervention during the study period. However, the access to the iWork.COMP program (and then to the SOS-Button tool) will be available after the study completion, if they choose to. Participants in this group will be assessed in four assessment-point (4-weeks intervals; approximately 10 minutes per assessment point): baseline, middle of the intervention, post-treatment, four-week follow-up.

Interventions

iWork.Comp BEHAVIORAL

The iWork.COMP is a short-term and low-time consuming internet delivery CFT-based intervention specifically designed to mitigate the impact of toxic leadership styles through the development of compassionate motivation in the workforce of EU hospitals. The iWork.COMP encompasses 8 individual sessions (20 minutes each; mixed format including text, audio and video presentations), which will be available weekly for participants at the KEEPCARING website (https://keepcaring.eu). Each session has three parts. Part 1 encompasses a brief check-in on the stress level of the participant at that moment and on the source of their stress (if applicable). In Part 2, the theme of the session is developed. Finally, Part 3 encompasses a brief check-in on the stress level of the participant at the end of the session and on the usefulness of the session; an optional open question to provide feedback will also be displayed.

Also known as: CFT for health care professionals

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Emerging/pre-service (Gen-Z) and current health care worker (i.e., doctors and nurses working in the surgical pathway);
• Aged over 18 years old;
• Assuming both leader and non-leader roles.

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Coimbra: lead
• European Union (Horizon Europe Programme): collaborator

Study Sites (1)

Faculty of Psychology and Educational Sciences of the University of Coimbra

Coimbra, 3000-115, Portugal

Location

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MeSH Terms

Interventions

Health Personnel

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Central Study Contacts

Diana Ribeiro da Silva, PhD

CONTACT

+351 239 851 450; uckeepcaring@fpce.uc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This project will use a longitudinal design. The healthcare units will be randomly assigned to two conditions: the TG and WLCG. Considering that concealment of group allocation is not possible within the iWork.COMP (which is a transversal issue in any psycho-educative/psychotherapeutic approach), this specific RCT will not have a blinded design.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

PT (1)