- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728958
Reflective Tasks With Healthcare Workers During COVID-19
Studying the Effect of Written Reflective Tasks With Healthcare Staff Working During the COVID-19 Health Pandemic
Study Overview
Status
Intervention / Treatment
Detailed Description
The healthcare workforce is amongst the most stressed in the UK, with 40.3% of staff feeling unwell as a result of work-related stress in the past year. This is steadily increasing each year, rising 3.5% from 36.8% since 2016. Chronic stress can cause psychological health problems, including low mood, anxiety and insomnia. Unfortunately, only 29.3% of staff across the NHS felt their trust took positive action on health and wellbeing, which may contribute to and prolong this continued rise in work-related stress.
With the COVID-19 health pandemic adding additional pressure to the NHS, healthcare workers (HCWs) are at further risk of mental health problems, including post-traumatic stress disorder, depression and substance misuse, as evident from historical health pandemics. Furthermore, preliminary data from China during the COVID-19 health pandemic indicated frontline HCWs experienced depression (50.4%), anxiety (44.6%), insomnia (34%) and distress (71.5%). A systematic review identified risk factors for increased psychological distress of HCWs during a health pandemic: being female, a nurse and experiencing stigmatised attitudes from the general public, as well as being quarantined. Perceived control and social support were associated with lower distress. Recommendations were made, to encourage a sense of autonomy (with information and resources), increase social support and to initiate public health campaigns with accurate facts, to reduce stigma and distress.
Positive Psychology Interventions (PPIs) are one approach for promoting autonomy and reducing distress, by increasing positive emotions, behaviours, and/or thoughts, thereby increasing the wellbeing of an individual. Positive psychology focuses on optimism, positive attitude and gratitude, to encourage creativity, improve happiness and reduce mental barriers to productivity, as opposed to focusing on 'problems'. PPIs include gratitude journals, using affirmations, strength focussing exercises and mindful meditations. PPIs in workplaces have improved performance, job wellbeing, engagement and other areas, whilst reducing negative performance and negative job wellbeing.
PPIs have focused on gratitude as a target for improving wellbeing, due to the inverse relationship found between gratitude and burnout. Burnout is a state of emotional and physical exhaustion, cynicism and detachment from work, caused by prolonged stress. Gratitude is a positive, social emotion, similar to appreciation, which can either be state (of being) or trait (dispositional). State gratitude is experienced when undeserved acts of kindness or generosity are given freely by another person. Whereas trait gratitude is viewed as a characteristic of a person, that varies in intensity and frequency throughout their daily life. Gratitude interventions have found improvements (with a small to medium effect size) in quality of relationships, wellbeing and optimism, alongside job satisfaction . Furthermore, a reduction in anxiety, depression and negative affect is also evident.
Gratitude interventions utilise both expression and self-reflection as their methodological properties. Expression includes giving small tokens of appreciation or paying gratitude visits. Self-reflection includes writing personal gratitude lists or journals. Gratitude lists were as effective as clinical therapies when working with excessive worry. Whereas, sharing a gratitude letter was not as effective at improving gratitude, furthermore expression of gratitude immediately induced feelings of embarrassment and discomfort. However, increases in elevation were noted here, namely improved job performance, connectedness, empowerment and autonomy. The reduced effectiveness of this expressive gratitude intervention, may be due to barriers in engagement with the intervention, including the expected awkwardness of the situation and the 'gratitude expresser's' mood.
Effectiveness of gratitude interventions in improving gratitude is likely to be affected by both traits of participants and specificities of the intervention, such as length. Research found trait gratitude moderated the effectiveness of the gratitude intervention in increasing gratitude. This supports the resistance hypothesis, suggesting that those who are predisposed to experience gratitude will not benefit from a gratitude intervention. Irrespective of gratitude moderation, wellbeing significantly improved. The duration of the intervention may also have an impact on effectiveness. Research found higher life satisfaction, more gratitude and an improved positive affect in HCWs, after writing a gratitude diary bi-weekly over 4-weeks. Whereas a shorter 5-day intervention in the workplace, using a similar journaling methodology, was not effective at improving gratitude. This may be explained by research, which found a cumulative improvement in gratitude and happiness over 8-weeks of grateful letter writing, indicating gratitude interventions are required to be of a reasonable length in order to be effective.
HCWs are suffering from psychological distress as a result of the COVID-19 health pandemic. It is vital interventions are offered to support their wellbeing. Gratitude interventions are effective at improving wellbeing and reducing psychological distress, namely the risk factors associated with psychological distress in HCWs at present. Self-reflective gratitude interventions, over a period of weeks are effective at improving gratitude with HCWs, without inducing embarrassment, discomfort or barriers to engagement. However, it is not clear if there are differences in effectiveness dependent upon the methodological properties of the intervention.
This study will aim to investigate the effects of a gratitude intervention with HCWs, with a view to increasing state gratitude and psychological wellbeing (subjective happiness and positive affect), whilst reducing psychological distress (negative affect and depression).
Objectives
- To investigate if gratitude interventions are effective at increasing state gratitude in HCWs
- To investigate if gratitude interventions are effective at reducing psychological distress and improving wellbeing in HCWs
- To investigate if high baseline trait gratitude is a moderator of changes in state gratitude, psychological distress and wellbeing after a gratitude intervention
Hypotheses
- A gratitude intervention will increase state gratitude in HCWs
- A gratitude intervention will improve wellbeing (positive affect and subjective happiness) and reduce psychological distress (depression and negative affect) in HCWs
- High levels of trait gratitude will moderate the outcomes
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sheffield, United Kingdom, S1 2LT
- University of Sheffield
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Staff working in a healthcare environment during the COVID-19 health pandemic, in clinical or non-clinical roles
- Basic understanding of the English language
Exclusion Criteria:
- Those engaged in other research projects
- Those without access to an electronic device to complete measures on
- Those without access to an email address
- Those receiving any other form of psychological intervention
- People who cannot commit to engage in a 4-week intervention study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gratitude Journal
Participants will be given instructions and asked to write a gratitude journal about their week, focusing upon what they are grateful for.
Over the course of the 4-week intervention they will be asked to do this weekly (a total of four times).
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A positive psychology intervention using expressions of gratitude
Other Names:
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Placebo Comparator: Weekly Diary
Participants will be given instructions and asked to write a diary about their week, focusing upon both the good and the bad they have experienced that week.
Over the course of the 4-week intervention they will be asked to do this weekly (a total of four times).
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A positive psychology intervention using expressions of gratitude
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Depression Level
Time Frame: Pre- to post-intervention (28 days)
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Patient Health Questionnaire-9 (PHQ-9).
This 9-item questionnaire, uses a 4-point likert scale to measure depression level.
Minimum score = 0; maximum score = 27.
Higher scores indicate higher levels of depression.
Positive change scores indicates a worse outcome.
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Pre- to post-intervention (28 days)
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Change in Subjective Happiness Level
Time Frame: Pre- to post-intervention (28 days)
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Subjective Happiness Scale (SHS).
This 4-item questionnaire, uses a 7-point likert scale to measure happiness level.
Minimum score = 7; maximum score = 28.
Higher scores indicate higher subjective happiness levels.
Positive change scores indicates a better outcome.
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Pre- to post-intervention (28 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in State Gratitude
Time Frame: Pre- to post-intervention (28 days)
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Gratitude Adjective Checklist (GAC).
This 3-item measures of state gratitude uses a 5-point likert scale.
Minimum score = 3; maximum score = 15.
Higher scores indicate higher levels of state gratitude.
A positive change score indicates a better outcome.
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Pre- to post-intervention (28 days)
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State Gratitude Score
Time Frame: Weekly (Day 1, Day 7, Day 14, Day 28)
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Gratitude Adjective Checklist (GAC).
This 3-item measures of state gratitude uses a 5-point likert scale.
Minimum score = 3; maximum score = 15.
Higher scores indicate higher levels of state gratitude.
A positive change score indicates a better outcome.
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Weekly (Day 1, Day 7, Day 14, Day 28)
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Change in Trait Gratitude
Time Frame: Pre- to post-intervention (28 days)
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The gratitude Questionnaire-6 (GQ-6).
This 6-item measure of trait gratitude uses a 7-point likert scale.
Minimum score = 6; maximum score = 42.
Higher scores indicate higher levels of Trait gratitude.
A positive change score indicates a better outcome.
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Pre- to post-intervention (28 days)
|
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Trait Gratitude score
Time Frame: Pre-intervention
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The gratitude Questionnaire-6 (GQ-6).
This 6-item measure of trait gratitude uses a 7-point likert scale.
Minimum score = 6; maximum score = 42.
Higher scores indicate higher levels of Trait gratitude.
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Pre-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Positive and Negative Affect
Time Frame: Weekly (Day 1, Day 7, Day 14, Day 28)
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The Positive and Negative Affect Scale - Short Form (PANAS-SF) is a 10-item measure of positive and negative affect.
It uses a 5-point likert scale across both positive and negative affect.
Positive affect is scored separately to negative affect, each with a minimum score of 5 and a maximum score of 25. High score on positive affect items indicate higher positive affect, whilst higher scores on negative affect items indicate higher negative affect.
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Weekly (Day 1, Day 7, Day 14, Day 28)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vicky Lamb, MSc, University of Sheffield
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 170732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD will be stored securely on the UniDrive, in a shared folder between the principal investigator and the research supervisor. Raw data will also be stored on the Qualtrics system, under a password protected log-in.
Study results will be available in the University of Sheffield Online Research Data (ORDA) hub once completed. Sensitive and personal information will not be available as the key linking participant numbers to the personal will be destroyed once the study is completed. The data available will be completely anonymised.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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