Quality Of LIfe Tool for IBD

NCT02707068 | Completed

• 1 other identifier: RJ116/N006
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to test the feasibility of a self-management manual with minimal telephone support by a healthcare professional. The study will also explore the acceptability of the intervention manual to patients.

Conditions

Inflammatory Bowel Disease

Keywords

Quality of Life; Self-help intervention

Outcome Measures

Primary Outcomes (7)

• Feasibility

  Percentage of patients eligible

  within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study)

• Acceptability

  Percentage of eligible patients consenting

  within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study)

• Effectiveness: Change in depression

  Assessing whether depression levels have changed from pre- to post-intervention (Patient Health Questionnaire, PHQ-9)

  within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

• Acceptability: Change in numbers of participants throughout the trial

  Percentage of consenting eligible participants retained until completion

  2 weeks of obtaining consent compared to 10 weeks post-randomisation

• Effectiveness: Change in anxiety

  Assessing whether anxiety levels have changed from pre- to post-intervention (Generalised Anxiety Disorder 7-item scale, GAD-7)

  within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

• Effectiveness: Change in generic quality of life

  Assessing whether generic quality of life levels have changed from pre- to post-intervention (EQ-5D-5L)

  within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

• Effectiveness: Change in Inflammatory Bowel Disease - specific quality of life

  Assessing whether IBD-specific quality of life levels have changed from pre- to post-intervention (Inflammatory Bowel Disease Questionnaire, IBDQ)

  within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

Secondary Outcomes (5)

• Semi-structured qualitative interviews

  at 12 weeks post-randomisation

• Change in fatigue

  within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

• Change in illness perception

  within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

• Change in disease activity

  within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

• Change in disease activity

  within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

Study Arms (2)

QOLITI

EXPERIMENTAL

Intervention group receives the QOLITI ("Quality Of LIfe Tool for IBD") manual immediately to work with over the course of several weeks along with 3 x 30 minutes of telephone support by a trained healthcare professional. Telephone calls will occur at two, four and six weeks post-randomisation. Participants will be invited to discuss their experiences after the end of the actual study. These interviews are no obligatory part of the QOLITI study.

Behavioral: Quality Of LIfe Tool for IBD (QOLITI)

Waitlist Control group (WLC)

NO INTERVENTION

Waitlist control group waits until after the study finishes to receive the same manual, but without telephone support sessions.

Interventions

Quality Of LIfe Tool for IBD (QOLITI) BEHAVIORAL

The cognitive-behavioural therapy (CBT)-inspired manual will contain several chapters each of which addresses a different topic with information, guidance in setting goals for behaviour change and accompanying tasks to aid implementation which will be completed at home in the participant's own time. Key themes are likely to include symptom management, dealing with social implications of the disease and interacting effectively with healthcare professionals among others. Each chapter will address a theme providing information, sign posting to appropriate organisations, step-by-step tasks and quotes from pwIBD among others, drawing on relevant therapeutic approaches for self-management including CBT and certain elements of Acceptance and Commitment Therapy.

QOLITI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with must have a diagnosis of IBD,
• be over 18 years of age as well as able to read and understand English fluently.
• Informed consent must be obtained.

You may not qualify if:

• Suicidal patients will be directly referred to liaison psychiatry or their GP and will not be able to access the study as the intensity of the manual intervention is within the low-moderate range and thus not suitable to address severe symptoms appropriately.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Health Psychology Section, Psychology Dept, Institute of Psychiatry, King's College London

London, London, SE1 9RT, United Kingdom

Location

Related Publications (20)

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• Keefer L, Doerfler B, Artz C. Optimizing management of Crohn's disease within a project management framework: results of a pilot study. Inflamm Bowel Dis. 2012 Feb;18(2):254-60. doi: 10.1002/ibd.21679. Epub 2011 Feb 23.

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• 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.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Lynsady D Hughes, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: March 14, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 6, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)