Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04728958
Other study ID # 170732
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 19, 2021
Est. completion date February 28, 2022

Study information

Verified date January 2021
Source University of Sheffield
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date February 28, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
Gratitude
A positive psychology intervention using expressions of gratitude

Locations

Country Name City State
United Kingdom University of Sheffield Sheffield

Sponsors (5)

Lead Sponsor Collaborator
University of Sheffield Bradford Teaching Hospitals NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Positive and Negative Affect 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)
Primary Change in Depression Level 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)
Primary Change in Subjective Happiness Level 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 Change in State Gratitude 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)
Secondary State Gratitude Score 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)
Secondary Change in Trait Gratitude 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)
Secondary Trait Gratitude score 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A