ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03059186
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Isebor, University of Sheffield

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Behavioral: Gratitude diary Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of a Brief Gratitude Intervention in Improving Well-being and Coping in People Living With Inflammatory Bowel Disease
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
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 Name: Count your blessings

No Intervention: Control



Primary Outcome Measures :
  1. Change in The Depression Anxiety and Stress Scale- 21 [ Time Frame: 1 week, and 8 weeks follow up. ]
    Change in wellbeing

  2. Change in the Inflammatory Bowel Disease Questionnaire UK [ Time Frame: 1 week, and 8 weeks follow up ]
    Change in health


Secondary Outcome Measures :
  1. Change in the IBD Self-efficacy scale [ Time Frame: 1 week and 8 weeks follow up ]
    Change in coping

  2. Change in the Gratitude Questionnaire 6 [ Time Frame: 1 week and 8 weeks follow up ]
    Change in gratitude

  3. Change in the Gratitude Adjectives Checklist [ Time Frame: 1 week and 8 weeks follow up ]
    Change in gratitude

  4. Change in Emotion Regulation Questionnaire-Revised [ Time Frame: 1 week and 8 weeks ]
    Change in emotion regulation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059186


Contacts
Contact: Peter Isebor, MSc 01142226650 pcisebor1@sheffield.ac.uk
Contact: Fuschia Sirois, Dr f.sirois@sheffield.ac.uk

Locations
United Kingdom
University of Sheffield Clinical Psychology Department Catherdral Court Recruiting
Sheffield, United Kingdom
Contact: Amrit Sinha       a.sinha@sheffield.ac.uk   
Sponsors and Collaborators
University of Sheffield
Investigators
Study Chair: Georgina Rowse, Dr Researcher/Supervisor
Study Chair: Amrit Sinha Research Support Secretary

Responsible Party: Peter Isebor, Principal Investigator, University of Sheffield
ClinicalTrials.gov Identifier: NCT03059186     History of Changes
Other Study ID Numbers: 151209
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis