Inflammatory Bowel Diseases Clinical Trial
Official title:
A Randomised Controlled Trial of a Brief Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease
| NCT number | NCT03059186 |
| Other study ID # | 151209 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 6, 2017 |
| Est. completion date | June 1, 2018 |
| Verified date | August 2018 |
| Source | University of Sheffield |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 129 |
| Est. completion date | June 1, 2018 |
| Est. primary completion date | June 1, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of inflammatory bowel disease from a clinician. Exclusion Criteria: - No access to internet via smartphone, tablet or computer. - Cannot read English |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Sheffield Clinical Psychology Department Catherdral Court | Sheffield |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sheffield |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in The Depression Anxiety and Stress Scale- 21 | Change in wellbeing | 1 week, and 8 weeks follow up. | |
| Primary | Change in the Inflammatory Bowel Disease Questionnaire UK | Change in health | 1 week, and 8 weeks follow up | |
| Secondary | Change in the IBD Self-efficacy scale | Change in coping | 1 week and 8 weeks follow up | |
| Secondary | Change in the Gratitude Questionnaire 6 | Change in gratitude | 1 week and 8 weeks follow up | |
| Secondary | Change in the Gratitude Adjectives Checklist | Change in gratitude | 1 week and 8 weeks follow up | |
| Secondary | Change in Emotion Regulation Questionnaire-Revised | Change in emotion regulation | 1 week and 8 weeks |
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