Quality Of LIfe Tool for IBD

Inflammatory Bowel Disease Clinical Trial

— QOLITI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707068
• Other study ID #: RJ116/N006
• Status: Completed
• Phase: N/A
• First received: February 4, 2016
• Last updated: March 3, 2017
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Health Psychology Section, Psychology Dept, Institute of Psychiatry, King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (19)

Bonaz BL, Bernstein CN. Brain-gut interactions in inflammatory bowel disease. Gastroenterology. 2013 Jan;144(1):36-49. doi: 10.1053/j.gastro.2012.10.003. Review. — View Citation

Cheung WY, Garratt AM, Russell IT, Williams JG. The UK IBDQ-a British version of the inflammatory bowel disease questionnaire. development and validation. J Clin Epidemiol. 2000 Mar 1;53(3):297-306. — View Citation

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Denters MJ, Schreuder M, Depla AC, Mallant-Hent RC, van Kouwen MC, Deutekom M, Bossuyt PM, Fockens P, Dekker E. Patients' perception of colonoscopy: patients with inflammatory bowel disease and irritable bowel syndrome experience the largest burden. Eur J Gastroenterol Hepatol. 2013 Aug;25(8):964-72. doi: 10.1097/MEG.0b013e328361dcd3. — View Citation

Graff LA, Walker JR, Clara I, Lix L, Miller N, Rogala L, Rawsthorne P, Bernstein CN. Stress coping, distress, and health perceptions in inflammatory bowel disease and community controls. Am J Gastroenterol. 2009 Dec;104(12):2959-69. doi: 10.1038/ajg.2009.529. — View Citation

Hüppe A, Langbrandtner J, Raspe H. [Assessing complex health problems of patients with IBD--first step to patient activation]. Z Gastroenterol. 2013 Mar;51(3):257-70. doi: 10.1055/s-0032-1325354. German. — View Citation

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. — View Citation

Knowles SR, Cook SI, Tribbick D. Relationship between health status, illness perceptions, coping strategies and psychological morbidity: a preliminary study with IBD stoma patients. J Crohns Colitis. 2013 Nov;7(10):e471-8. doi: 10.1016/j.crohns.2013.02.022. — View Citation

Marri SR, Buchman AL. The education and employment status of patients with inflammatory bowel diseases. Inflamm Bowel Dis. 2005 Feb;11(2):171-7. Review. — View Citation

Moradkhani A, Beckman LJ, Tabibian JH. Health-related quality of life in inflammatory bowel disease: psychosocial, clinical, socioeconomic, and demographic predictors. J Crohns Colitis. 2013 Jul;7(6):467-73. doi: 10.1016/j.crohns.2012.07.012. — View Citation

Moss-Morris R, McAlpine L, Didsbury LP, Spence MJ. A randomized controlled trial of a cognitive behavioural therapy-based self-management intervention for irritable bowel syndrome in primary care. Psychol Med. 2010 Jan;40(1):85-94. doi: 10.1017/S0033291709990195. — View Citation

Nahon S, Lahmek P, Durance C, Olympie A, Lesgourgues B, Colombel JF, Gendre JP. Risk factors of anxiety and depression in inflammatory bowel disease. Inflamm Bowel Dis. 2012 Nov;18(11):2086-91. doi: 10.1002/ibd.22888. — View Citation

Tang LY, Nabalamba A, Graff LA, Bernstein CN. A comparison of self-perceived health status in inflammatory bowel disease and irritable bowel syndrome patients from a Canadian national population survey. Can J Gastroenterol. 2008 May;22(5):475-83. — View Citation

Taylor RS, Watt A, Dalal HM, Evans PH, Campbell JL, Read KL, Mourant AJ, Wingham J, Thompson DR, Pereira Gray DJ. Home-based cardiac rehabilitation versus hospital-based rehabilitation: a cost effectiveness analysis. Int J Cardiol. 2007 Jul 10;119(2):196-201. — View Citation

Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. — View Citation

Thompson RD, Craig A, Crawford EA, Fairclough D, Gonzalez-Heydrich J, Bousvaros A, Noll RB, DeMaso DR, Szigethy E. Longitudinal results of cognitive behavioral treatment for youths with inflammatory bowel disease and depressive symptoms. J Clin Psychol Med Settings. 2012 Sep;19(3):329-37. doi: 10.1007/s10880-012-9301-8. — View Citation

Triantafillidis JK, Merikas E, Gikas A. Psychological factors and stress in inflammatory bowel disease. Expert Rev Gastroenterol Hepatol. 2013 Mar;7(3):225-38. doi: 10.1586/egh.13.4. Review. — View Citation

van Kessel K, Moss-Morris R, Willoughby E, Chalder T, Johnson MH, Robinson E. A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. Psychosom Med. 2008 Feb;70(2):205-13. doi: 10.1097/PSY.0b013e3181643065. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Percentage of patients eligible	within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study)
Primary	Acceptability	Percentage of eligible patients consenting	within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Semi-structured qualitative interviews	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
Secondary	Change in fatigue	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
Secondary	Change in illness perception	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
Secondary	Change in disease activity	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
Secondary	Change in disease activity	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