Clinical trial NCT07018089: The Efficacy of the iWork.COMP Among Health Care Professionals
Official title: The Efficacy of the iWork.COMP Among Health Care Professionals: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Impact of Toxic Leadership Styles on Mental Health and Wellbeing of Health Care Professionals
Keywords: Health care workers
Surgical pathway
Clinical Trial
Compassion Focused Therapy
iWork.COMP
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: European Union (Horizon Europe Programme)
First posted: 2025-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 1. Introduction Healthcare workers are in significant risk for the development of psychopathology, including depression, anxiety (Hao et al., 2021), psychological distress (Batra et al., 2020) and burnout symptoms (Boucher et al., 2025). According to the European Agency for Safety and Health Work (EU-OSHA; https://osha.europa.eu/en), there are several factors that may contribute to these mental health issues, such as excessive workload, conflicting demands and lack of role clarity, lack of involvement in making decisions that affect the worker, poorly managed organizational change, ineffective communication, and lack of support from management. These factors can be directly or indirectly related to leadership styles (LeBreton et al., 2018). Within leadership research, there has been an increasing interest in the study of toxic leadership, as a form of malicious leadership (Whicker, 1996), in which leaders, through dysfunctional behaviour and/or deviant personality traits (psychopathic, Machiavelism, narcissistic), negatively impact on the mental health and wellbeing of the workforce (LeBreton et al., 2018; Lipman-Blumen, 2010). Despite its relevance, there is an absence of studies on the efficacy of intervention programs aimed at reducing the impact of toxic leadership styles in the workplace, namely among health care professionals (Wasson et al., 2020).

   Whitin psychotherapeutic interventions, there has been a growing empirical support for compassion-based interventions (e.g., Compassion-Focused Therapy; CFT), in a wide range of contexts (Kirby et al., 2017). Recent studies have shown that 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 (Gilbert \& Simos, 2022; Ribeiro da Silva et al., 2021). 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 (e.g., Matos et al., 2022). Compassion can be conceptualized as a motivation to be sensitive to the suffering of one-self and others, allied with the wisdom and commitment to prevent and/or relieve it (Gilbert, 2009). It is linked with psychological well-being (Zessin et al., 2015) and has been found to be negatively associated with emotion dysregulation (Gouveia et al., 2018), shame and self-criticism (Gilbert \& Procter, 2006). In the workplace, compassion has been linked with work commitment and work satisfaction (Eldor \& Shoshani, 2016). Moreover, compassion at work has been negatively associated with burnout symptoms (Santoro et al., 2022). 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. These mitigation programs can impact on an individual, team, and organizational levels. Promoting a compassionate motivation among health care professionals is crucial to their mental and physical health, to their wellbeing at work, and, consequently, to the delivery of safe, high-quality, and patient-centered care to the population.
2. Study Design This study will follow a Randomized Controlled Trial design (RCT; CONSORT-Statement; Montgomery et al., 2018) involving health care units from the Health Local Unity of Coimbra (HLU Coimbra; selected by the hospital's administration). The selected health care units will be randomly assigned to the Treatment Group (TG) and to the Waiting List Control Group WLCG). The randomization at the health care unit level (and not at an individual level) intends to maximize the intervention effects, as all participants will be receiving the intervention at the same time, potentially boosting and cumulating individual and team intervention effects (e.g., Matos et al., 2022).

   Individuals who agree to participate in this RCT will sign an informed consent and will be asked to fulfil their socioeconomic data and a set of questionnaires (baseline assessment, M0). Participants will be assessed in three more assessment points (4-weeks intervals): middle of the intervention (M1), post treatment (M2) and 4-week follow-up (M3). All assessments (M0 to M3) will approximately take 10 minutes.
3. Participants Participants will be 200 emerging/pre-service (Gen-Z) and current health care workers (i.e., doctors and nurses working in the surgical pathway), aged over 18 years old and assuming both leader and non-leader roles in two (or more) similar Portuguese health care units. As the iWork.COMP program aims to be applied to all the workforce, no more restrictions are planned on age as well as on gender distribution.

   Regarding the sample size, a power analysis was conducted a priori (GPower v3.1 software; Faul et al., 2009), specifying for F tests (multivariate analysis of variances: repeated measures, within-between interaction), showing that a sample of 162 participants was necessary to detect medium effects with a significance level of .05 and a power of .90.
4. Intervention 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.

   At the end of the iWork.COMP, participants will have full access to a SOS-Button tool, which aims to provide short-term exercises when one is dealing with an acute stressful situation.
5. Measures During the four assessment moments, both TG and WLCG participants will answer a set of questionnaires already validated for the Portuguese population, aimed at measuring toxic leadership styles (Toxic Leadership Scale; TLS; Schmidt, 2008; Portuguese version: Mónico et al., 2019), deviant personality traits (Dirty Dozen; DD; Jonason \& Webster, 2010; Portuguese version: Antunes et al., 2021), burnout (Burnout Assessment Tool; BAT-12; Schaufeli et al., 2020; Portuguese version: Sinval et al., 2022), wellbeing (Daniels's Five-Factor Measure; D-FAW; Russell \& Daniels, 2018; Portuguese version: Valdman et al., 2023), and compassion (Fears of Compassion Scales; FCS; Gilbert et al., 2011 ; Matos et al., 2011). A detailed description of these questionnaires will be presented in the outcome measures section.
6. Data analysis The data will be analyzed with SPSS v29 and Mplus v8 statistical software. Preliminary analyses, namely for comparisons between groups at baseline on sociodemographic data and outcome measures, will resort to independent-samples t-tests and chi-square tests. Internal consistency calculations will be based on Cronbach's alpha guidelines (George \& Mallery, 2003). To test the efficacy of the iWork.COMP, data will be analyzed both at an individual (Reliable Change Index) and group level (Latent Growth Curve Models). If Latent Growth Curve models don't present acceptable fit indices, treatment effects will be assessed through MANOVAs.
7. Ethical Considerations To address any ethical considerations, a series of procedures will be carried out.

First, all procedures involved in this project will be allied with the ethical principles of the Declaration of Helsinki and the European Code of Conduct for Research Integrity. Applicable national laws and regulations will also be followed. Moreover, all procedures were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra (CEDI/FPCEUC: 97/4).

Second, after the selection and randomization of the health care units, it will be conducted a series of meetings with the leaders and staff of the units. These meetings intend to inform about the nature and aims of the study, to explain the assessment procedures, to clarify any doubt that may arise, and to invite them to voluntarily participate. It will be explained that their decision to participate or not will have no negative consequences or monetary rewards, and that they can withdraw from the study at any time without further explanation. Confidentiality and anonymity will be guaranteed. Participants will fulfil a written informed consent.

Third, participants will be asked to provide their e-mail address (optional). The e-mail addresses will not be linked with the individual data of participants and will only be used to notify them regarding the availability of the sessions (for the TG) and/or assessment periods (for both TG and WLCG). Participants can ask to be removed from the mailing list at any time without further explanations.

Four, to assure data confidentiality, the following procedures will be carried out: 1) use of a system code in each research protocol; 2) unpair the research protocol and the informed consent, to maintain participants' anonymity; 3) collect personal data strictly necessary for research purposes; 4) enter data in statistical software, analyzing them exclusively in a collective way; 5) use of respondent-specific codes to link data from one time-point to the next.

Fifth, although participants in the WLCG will not receive any intervention during the study period, they will be able to access the iWork.COMP program (and then to the SOS-Button tool) after the study completion, if they choose to.

Eligibility criteria: Inclusion Criteria:

* 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 and assuming both leader and non-leader roles in two (or more) similar Portuguese health care units. As the iWork.COMP program aims to be applied to all the workforce, no more restrictions are planned on age as well as on gender distribution.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: The Toxic Leadership Scale
timeFrame: Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)
Secondary outcomes:
measure: The Dirty Dozen
timeFrame: Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)
measure: The Burnout Assessment Tool
timeFrame: Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)
measure: The Daniels's Five-Factor Measure
timeFrame: Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)
measure: The Fears of Compassion Scales
timeFrame: Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Educational Sciences of the University of Coimbra
Study officials:
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