The Efficacy of the iWork.COMP Among Health Care Professionals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Coimbra

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

N/A

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 1 intervention
Group B: Waiting List Control GroupNo intervention 0 interventions

Trial outcomes

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).

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

Secondary outcomes

1

The Dirty Dozen

Dark Triad: The Dirty Dozen (DD) is a brief 12-item questionnaire that aims to measures the "Dark Triad", as a constellation of three overlapping, although distinct, constructs: Machiavellianism (i.e., a manipulative and cold interpersonal style), Psychopathy (i.e., a callous, unemphatic and impulsive style), and Narcissism (i.e., a grandiose and dominant style). Items are scored using a five-point Likert-type scale ranging from 1 (Totally Disagree) to 5 (Totally Agree). Higher total scores indicate higher levels of Dark Triad traits. The other-report version of the scale will be used in the present study to assess employees' perception of their direct leader's Dark Triad traits. Psychometric studies of the other-report version of the DD have demonstrated good to very good internal consistency (α ranging from .87 to .93).

Time frame
Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)
2

The Burnout Assessment Tool

The Burnout Assessment Tool (BAT-12) is a brief 12-item self-report instrument that measures participant's four core burnout symptoms: Exhaustion (e.g., "At work, I feel physically exhausted."), Mental Distance (e.g., "I struggle to find any enthusiasm for my work."), Cognitive Impairment (e.g., "At work, I have problems staying focused."), and Emotional Impairment (e.g., "At work, I feel unable to control my emotions."). Items are rated on a five-point Likert-type scale ranging from 1 (Never) to 5 (Always). Higher scores indicate the participant's frequency of these symptoms. The BAT-12 will be used in the present study to assess employees' burnout symptoms and respective frequency. Psychometric studies of the BAT-12 have demonstrated good to very good internal consistency (α ranging from .85 to .95).

Time frame
Baseline; 4 weeks (middle intervention); 8 weeks (post-intervention); 12 weeks (Follow-up)
3

The Daniels's Five-Factor Measure

The Daniels's Five-Factor Measure (D-FAW) is a self-report questionnaire aimed at measuring participants' affective wellbeing in the past week at work. It comprised 10 items that purports to measure levels of Positive Activated Affect (PA; e.g., Happy", "At ease") and Negative Activated Affect (NA; e.g., "Anxious", "Tired"). Participants will be instructed to classify the feelings experienced using a five-point Likert-type scale ranging from 1 (Not at all) to 6 (Very much). Higher total scores indicate greater affective wellbeing at work, after the five items related to negative emotions have been reversed. Studies have demonstrated a good internal consistency for the PA and NA factors (α \> .80 and .80).

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

The Fears of Compassion Scales

The Fears of Compassion Scales (FCS) include three self-report questionnaires (total of 38-items) aimed at measuring fears, blocks and resistances to the three flows of compassion as posted by the CFT framework: expressing compassion for others (10 items; e.g., "People will take advantage of me if they see me as too compassionate"); receiving compassion from others (13 items; e.g., "Wanting others to be kind to oneself is a weakness"); and being self-compassionate (15 items; e.g., "I feel that I don't deserve to be kind and forgiving to myself"). Items are rated on a five-point Likert-type scale ranging from 0 (Don't agree at all) to 4 (Completely agree). These scales have been presenting acceptable to very good internal consistencies (α ranging from .78 to .87 on the original version; ranging from .88 to .94 in the Portuguese version).

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

Other outcomes

Sponsors and contacts

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University of Coimbra

Lead sponsor

European Union

Collaborator

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