Quality Of LIfe Tool for IBD (QOLITI)

March 3, 2017 updated by: King's College London

Quality Of LIfe Tool for IBD (QOLITI): Pilot Testing of a Self-administered Intervention to Target Psychological Distress in Inflammatory Bowel Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Psychological distress and poor quality of life are common in Long Term Conditions (LTCs) including Inflammatory Bowel Disease (IBD). Rates of depression are 11-21% in people with IBD (pwIBD) with high levels of anxiety in 41%. Additionally, as diagnosis typically occurs at 15-40 years, educational and employment attainment can be effected and symptoms and medical procedures such as diarrhoea and colonoscopies can be stressful and embarrassing. The relapsing and remitting nature can also cause uncertainty and fear of social integration.

Most of the psychosocial literature in IBD has focused on the potential impact of stress and recording the prevalence and non-modifiable predictors of depression and anxiety such as active disease, hospitalisation, surgery (particularly stoma formation) and unemployment. Less research in IBD has investigated potentially modifiable factors known to be related to distress and quality of life in other LTCs such as illness perceptions, social support and coping strategies, although one study has found a similar association in IBD. This is of particular interest due to the potential behavioural and physiological pathways through which they could impact on health and quality of life.

Psychosocial interventions in IBD to date have focused on stress management or Cognitive Behavioural Therapy (CBT) to reduce distress and improve quality of life. Although small sample studies have shown small to moderate benefits of the interventions, these approaches are time consuming and resource intensive such as group or individual therapy. This can result in low adherence and retention due to the required time commitment, but more importantly are not widely applicable in the NHS due to limited available expertise and in particular, their cost. Psychological interventions are most effective when tailored specifically to disease-related factors and the patients' developmental stage. Such interventions are currently lacking for IBD.

An alternative to therapist-led intervention is to promote self-management through paper or online self-help interventions supplemented by minimal guided support by a health care professional. This type of supported, self-directed intervention is cost-effective and has shown strongest results when targeted to the needs of specific diseases. There is currently no similar self-directed manual for IBD available. This type of supported, self-directed intervention can be incorporated into standard care where required, is cost-effective and has the potential to support pwIBD to successfully adjust to their LTC for better clinical and quality of life outcomes. Although most people will not require intensive psychological therapy for debilitating distress, structured support to adjust to the many demands that IBD places on people could help to bridge the gap for the 40-50% of pwIBD that show moderate levels of distress, improving their quality of life and management of the illness.

Sample size justification: A sample size of 30 per group is in line with recommendations for pilot studies where the aim is to determine the feasibility of a future efficacy study by estimating the treatment effect (for a power calculation) and estimating rate of non-completion of the intervention. A minimum total sample size of 50 (i.e. 25 per group) is recommended to allow for a precise estimate of the pooled standard deviation at the post intervention assessment. Increasing the number to 30 per group allows for non-completion of up to 20%. Furthermore, a sample size of 30 per group allows for an acceptably precise estimate of the non-completion rate; a 95% confidence interval less than +/-11% for completion rates of 80% or higher.

Adults (>18 years) with IBD will be provided with an information sheet and invited to participate in the study. Following informed consent and the completion of baseline questionnaires, participants will be randomised to receive either intervention + treatment as usual (treatment group) or treatment as usual (control group). Randomisation will be completed by King's College London Clinical Trials Unit independently of the research team so that the researchers remain blind to condition.

As recommended for a pilot or feasibility study, results will be mainly descriptive and will include; proportion of eligible people; consent rate; retention rate. The investigators plan on using an intention-to-treat regression analysis and include the pre measure as a covariate. This data will allow for effect sizes and feasibility to be determined in order to adequately power a full trial of the intervention in a follow-up study. Thematic analysis of the qualitative feedback data will be conducted by a member independent of the research team.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Health Psychology Section, Psychology Dept, Institute of Psychiatry, King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participants are not eligible for the study, if they do not fulfil the inclusion criteria.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QOLITI

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)
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.
No Intervention: Waitlist Control group (WLC)
Waitlist control group waits until after the study finishes to receive the same manual, but without telephone support sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study)
Percentage of patients eligible
within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study)
Acceptability
Time Frame: within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study)
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
Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
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
Time Frame: 2 weeks of obtaining consent compared to 10 weeks post-randomisation
Percentage of consenting eligible participants retained until completion
2 weeks of obtaining consent compared to 10 weeks post-randomisation
Effectiveness: Change in anxiety
Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
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
Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
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
Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-structured qualitative interviews
Time Frame: at 12 weeks post-randomisation
semi-structured qualitative interviews of up to 30 minutes to obtain retrospective appraisal of the intervention (i.e. content and layout), conducted by a person independent of the research group, transcribed data will be analysed based on principles of grounded theory
at 12 weeks post-randomisation
Change in fatigue
Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
Assessing whether fatigue levels have changed from pre- to post-intervention (Chalder Fatigue Scale, CFS)
within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
Change in illness perception
Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
Assessing whether illness perception has changed from pre- to post-intervention (Illness Perception Questionnaire, IPQ-R)
within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
Change in disease activity
Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
Assessing whether subjective levels if disease activity have changed from pre- to post-intervention (patient-modified Simple Clinical Colitis Activity Index, p-SCCAI)
within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
Change in disease activity
Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation
Assessing whether subjective levels if disease activity have changed from pre- to post-intervention (Crohn's Disease Activity Index for research surveys, CDAI for research surveys)
within 2 weeks of obtaining consent as well as 10 weeks post-randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Lynsady D Hughes, PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ116/N006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators seek to publish the results of the study which are going to be based on group statistics only, i.e. no individual patient data will be made available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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