A Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease

August 8, 2018 updated by: Peter Isebor, University of Sheffield

A Randomised Controlled Trial of a Brief Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease

The primary aim of the proposed research is to investigate the extent to which a one-week online gratitude intervention can improve levels of wellbeing in individuals living with Inflammatory Bowel Disease (IBD). A secondary aim was to investigate the extent to which dispositional gratitude influences levels of coping and wellbeing and to what extent this mediates the effect of the intervention. Participants with IBD will be randomized to either treatment or control group. Participants will complete measures pre- and post- intervention, and follow-up (eight weeks) measuring: gratitude (state and trait), illness severity, mood, stress and coping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • 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
        • University of Sheffield Clinical Psychology Department Catherdral Court

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

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of inflammatory bowel disease from a clinician.

Exclusion Criteria:

  • No access to internet via smartphone, tablet or computer.
  • Cannot read English

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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Intervention
Online daily gratitude journal.
Behavioral: Gratitude diary

The intervention involves keeping a record of three things that the individual feels grateful for during that day.

This can be completed daily, and for the purpose of this study will be completed every evening for the duration of one week.

Other Names:
  • Count your blessings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in The Depression Anxiety and Stress Scale- 21
Time Frame: 1 week, and 8 weeks follow up.
Change in wellbeing
1 week, and 8 weeks follow up.
Change in the Inflammatory Bowel Disease Questionnaire UK
Time Frame: 1 week, and 8 weeks follow up
Change in health
1 week, and 8 weeks follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the IBD Self-efficacy scale
Time Frame: 1 week and 8 weeks follow up
Change in coping
1 week and 8 weeks follow up
Change in the Gratitude Questionnaire 6
Time Frame: 1 week and 8 weeks follow up
Change in gratitude
1 week and 8 weeks follow up
Change in the Gratitude Adjectives Checklist
Time Frame: 1 week and 8 weeks follow up
Change in gratitude
1 week and 8 weeks follow up
Change in Emotion Regulation Questionnaire-Revised
Time Frame: 1 week and 8 weeks
Change in emotion regulation
1 week and 8 weeks

Collaborators and Investigators

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

Sponsor

University of Sheffield

Investigators

  • Study Chair: Georgina Rowse, Dr, Researcher/Supervisor
  • Study Chair: Amrit Sinha, Research Support Secretary

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)

June 6, 2017

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151209

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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