Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-26 @ 6:55 PM
Study NCT ID:
NCT02707068
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2016-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Of LIfe Tool for IBD
Sponsor:
King's College London
Organization:
Study Overview
Official Title:
Quality Of LIfe Tool for IBD (QOLITI): Pilot Testing of a Self-administered Intervention to Target Psychological Distress in Inflammatory Bowel Disease
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QOLITI
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: