Back to resultsA Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Gratitude diary
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of inflammatory bowel disease from a clinician.
Exclusion Criteria:
- No access to internet via smartphone, tablet or computer.
- Cannot read English
Sites / Locations
- University of Sheffield Clinical Psychology Department Catherdral Court
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Online daily gratitude journal.
Outcomes
Primary Outcome Measures
Change in The Depression Anxiety and Stress Scale- 21
Change in wellbeing
Change in the Inflammatory Bowel Disease Questionnaire UK
Change in health
Secondary Outcome Measures
Change in the IBD Self-efficacy scale
Change in coping
Change in the Gratitude Questionnaire 6
Change in gratitude
Change in the Gratitude Adjectives Checklist
Change in gratitude
Change in Emotion Regulation Questionnaire-Revised
Change in emotion regulation
Full Information
NCT ID
NCT03059186
First Posted
February 14, 2017
Last Updated
August 8, 2018
Sponsor
University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT03059186
Brief Title
A Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease
Official Title
A Randomised Controlled Trial of a Brief Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Online daily gratitude journal.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Gratitude diary
Other Intervention Name(s)
Count your blessings
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in The Depression Anxiety and Stress Scale- 21
Description
Change in wellbeing
Time Frame
1 week, and 8 weeks follow up.
Title
Change in the Inflammatory Bowel Disease Questionnaire UK
Description
Change in health
Time Frame
1 week, and 8 weeks follow up
Secondary Outcome Measure Information:
Title
Change in the IBD Self-efficacy scale
Description
Change in coping
Time Frame
1 week and 8 weeks follow up
Title
Change in the Gratitude Questionnaire 6
Description
Change in gratitude
Time Frame
1 week and 8 weeks follow up
Title
Change in the Gratitude Adjectives Checklist
Description
Change in gratitude
Time Frame
1 week and 8 weeks follow up
Title
Change in Emotion Regulation Questionnaire-Revised
Description
Change in emotion regulation
Time Frame
1 week and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of inflammatory bowel disease from a clinician.
Exclusion Criteria:
No access to internet via smartphone, tablet or computer.
Cannot read English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgina Rowse, Dr
Organizational Affiliation
Researcher/Supervisor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amrit Sinha
Organizational Affiliation
Research Support Secretary
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sheffield Clinical Psychology Department Catherdral Court
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease
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