Reflective Tasks With Healthcare Workers During COVID-19

May 17, 2022 updated by: University of Sheffield

Studying the Effect of Written Reflective Tasks With Healthcare Staff Working During the COVID-19 Health Pandemic

The healthcare workforce is amongst the most stressed in the United Kingdom (UK). The Coronavirus (COVID-19) health pandemic has increased depression, anxiety, insomnia and distress in this population. Gratitude interventions have been shown to improve wellbeing, alongside reducing risk factors associated with the aforementioned mental health conditions. This online Randomised Control Trial of 219 healthcare staff, will investigate the effects of a gratitude intervention on wellbeing (gratitude, positive affect, happiness) and psychological distress (depression and negative affect). Means of pre- and post-outcome measures of two groups (gratitude journal and control) will be assessed for differences utilising t-tests.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

  1. To investigate if gratitude interventions are effective at increasing state gratitude in HCWs
  2. To investigate if gratitude interventions are effective at reducing psychological distress and improving wellbeing in HCWs
  3. To investigate if high baseline trait gratitude is a moderator of changes in state gratitude, psychological distress and wellbeing after a gratitude intervention

Hypotheses

  1. A gratitude intervention will increase state gratitude in HCWs
  2. A gratitude intervention will improve wellbeing (positive affect and subjective happiness) and reduce psychological distress (depression and negative affect) in HCWs
  3. High levels of trait gratitude will moderate the outcomes

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S1 2LT
        • University of Sheffield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: Gratitude
A positive psychology intervention using expressions of gratitude
Other Names:
  • Gratitude Letter
  • Gratitude Diary
  • Gratitude Journal
  • Appreciation Letter
  • expressing gratitude
  • positive psychology intervention
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).
Behavioral: Gratitude
A positive psychology intervention using expressions of gratitude
Other Names:
  • Gratitude Letter
  • Gratitude Diary
  • Gratitude Journal
  • Appreciation Letter
  • expressing gratitude
  • positive psychology intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Depression Level
Time Frame: Pre- to post-intervention (28 days)
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.
Pre- to post-intervention (28 days)
Change in Subjective Happiness Level
Time Frame: Pre- to post-intervention (28 days)
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.
Pre- to post-intervention (28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in State Gratitude
Time Frame: Pre- to post-intervention (28 days)
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.
Pre- to post-intervention (28 days)
State Gratitude Score
Time Frame: Weekly (Day 1, Day 7, Day 14, Day 28)
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.
Weekly (Day 1, Day 7, Day 14, Day 28)
Change in Trait Gratitude
Time Frame: Pre- to post-intervention (28 days)
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.
Pre- to post-intervention (28 days)
Trait Gratitude score
Time Frame: Pre-intervention
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.
Pre-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive and Negative Affect
Time Frame: Weekly (Day 1, Day 7, Day 14, Day 28)
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.
Weekly (Day 1, Day 7, Day 14, Day 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sheffield

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Leeds Teaching Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Bradford Teaching Hospitals NHS Foundation Trust
York Teaching Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vicky Lamb, MSc, University of Sheffield

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 170732

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

No

Studies a U.S. FDA-regulated device product

No

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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