NCT03059186

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

February 14, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

February 14, 2017

Last Update Submit

August 8, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in The Depression Anxiety and Stress Scale- 21

    Change in wellbeing

    1 week, and 8 weeks follow up.

  • Change in the Inflammatory Bowel Disease Questionnaire UK

    Change in health

    1 week, and 8 weeks follow up

Secondary Outcomes (4)

  • Change in the IBD Self-efficacy scale

    1 week and 8 weeks follow up

  • Change in the Gratitude Questionnaire 6

    1 week and 8 weeks follow up

  • Change in the Gratitude Adjectives Checklist

    1 week and 8 weeks follow up

  • Change in Emotion Regulation Questionnaire-Revised

    1 week and 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Online daily gratitude journal.

Behavioral: Gratitude diary

Control

NO INTERVENTION

Interventions

Gratitude diaryBEHAVIORAL

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.

Also known as: Count your blessings
Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of inflammatory bowel disease from a clinician.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sheffield Clinical Psychology Department Catherdral Court

Sheffield, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Georgina Rowse, Dr

    Researcher/Supervisor

    STUDY CHAIR
  • Amrit Sinha

    Research Support Secretary

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 23, 2017

Study Start

June 6, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations