NCT04728958

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

May 24, 2022

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 11, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

Gratitude

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (4)

  • Change in State Gratitude

    Pre- to post-intervention (28 days)

  • State Gratitude Score

    Weekly (Day 1, Day 7, Day 14, Day 28)

  • Change in Trait Gratitude

    Pre- to post-intervention (28 days)

  • Trait Gratitude score

    Pre-intervention

Other Outcomes (1)

  • Positive and Negative Affect

    Weekly (Day 1, Day 7, Day 14, Day 28)

Study Arms (2)

Gratitude Journal

EXPERIMENTAL

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

Weekly Diary

PLACEBO COMPARATOR

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

Interventions

GratitudeBEHAVIORAL

A positive psychology intervention using expressions of gratitude

Also known as: Gratitude Letter, Gratitude Diary, Gratitude Journal, Appreciation Letter, expressing gratitude, positive psychology intervention
Gratitude JournalWeekly Diary

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Staff working in a healthcare environment during the COVID-19 health pandemic, in clinical or non-clinical roles
  • Basic understanding of the English language

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sheffield

Sheffield, S1 2LT, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Vicky Lamb, MSc

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will only be aware of the arm they are allocated to and not the other arms available. They will also be unaware as to whether this is a treatment arm or the comparator control
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: T-tests compare the mean differences between groups split across the two IVs (intervention \& time), due to the between factors and within factors levels of the two IVs. Descriptive Statistics \& t-tests will be used to compare and assess cumulative gratitude week-by-week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 28, 2021

Study Start

March 19, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

May 24, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

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.

Locations