Inflammatory Bowel DiseasesNCT03059186
A Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease
A study testing Gratitude diary in people with Inflammatory Bowel Diseases, run by University of Sheffield at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Gratitude diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of inflammatory bowel disease from a clinician.
Who cannot join
- No access to internet via smartphone, tablet or computer.
- Cannot read English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Sheffield Clinical Psychology Department Catherdral Court
Sheffield
About this study
Official title: 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Gratitude diary
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gratitude diaryBehavioural
Also called Count your blessings
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Online daily gratitude journal. Receives: Behavioral: Gratitude diary |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Depression Anxiety and Stress Scale- 21
Change in wellbeing
Measured: 1 week, and 8 weeks follow up.
Change in the Inflammatory Bowel Disease Questionnaire UK
Change in health
Measured: 1 week, and 8 weeks follow up
Secondary outcomes (4)
Change in the IBD Self-efficacy scale
Change in coping
Measured: 1 week and 8 weeks follow up
Change in the Gratitude Questionnaire 6
Change in gratitude
Measured: 1 week and 8 weeks follow up
Change in the Gratitude Adjectives Checklist
Change in gratitude
Measured: 1 week and 8 weeks follow up
Change in Emotion Regulation Questionnaire-Revised
Change in emotion regulation
Measured: 1 week and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start6 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Isebor, University of Sheffield
- Investigators
- Georgina Rowse, Dr, Study chair, Researcher/SupervisorAmrit Sinha, Study chair, Research Support Secretary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059186
- Sponsor's protocol ID
- 151209
- Status last verified
- Aug 2018
- First submitted
- 14 Feb 2017
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Brief Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03059186
- Acronym / sponsor ID
- 151209
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Gratitude diaryOnline daily gratitude journal. |
| Control | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of inflammatory bowel disease from a clinician.
Key exclusion criteria (2 listed)
- No access to internet via smartphone, tablet or computer.
- Cannot read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gratitude diaryAlso: Count your blessingsThe 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. | Behavioural | Intervention |
Primary outcome
Change in The Depression Anxiety and Stress Scale- 21
Time frame: 1 week, and 8 weeks follow up.
Change in wellbeing
Change in the Inflammatory Bowel Disease Questionnaire UK
Time frame: 1 week, and 8 weeks follow up
Change in health
4 secondary outcomes
Change in the IBD Self-efficacy scale
Time frame: 1 week and 8 weeks follow up
Change in the Gratitude Questionnaire 6
Time frame: 1 week and 8 weeks follow up
Change in the Gratitude Adjectives Checklist
Time frame: 1 week and 8 weeks follow up
Change in Emotion Regulation Questionnaire-Revised
Time frame: 1 week and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgina Rowse, Dr study chair
Researcher/Supervisor
Amrit Sinha study chair
Research Support Secretary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude diary in people with Inflammatory Bowel Diseases, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Depression Anxiety and Stress Scale- 21 (time frame: 1 week, and 8 weeks follow up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.