Inflammatory Bowel Disease (IBD)NCT01852097
An Online Intervention to Address Barriers to IBD Medication Adherence
A study testing CBT based online intervention to elicit and address perceptual and practical barriers to taking medication. in people with Inflammatory Bowel Disease (IBD), run by University College, London.
Trial summary
Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing inflammatory conditions that usually affect the colon and the small intestine. Between 30 to 45% of patients with IBD do not take their treatment as prescribed by their health care team (Jackson, Clatworthy et al. 2010). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over.
- Diagnosis of IBD (Crohn's Disease or Ulcerative Colitis or Indeterminate Colitis).
- Currently prescribed one or more of the following medications for IBD: azathioprine, mesalazine, and adalimumab.
Who cannot join
- We will exclude people who are for any reason unable to make an informed decision about taking part and people who do not wish to complete follow-up questionnaires.
- People who declare that they do not understand written English. This is a pilot feasibility study that aims to assess the effectiveness and acceptability of an online CBT based intervention in English.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Randomised Controlled Trial to Determine the Feasibility, Acceptability and Effectiveness of a CBT Based Online Intervention to Address Practical and Perceptual Barriers to Medication Adherence in Inflammatory Bowel Disease.
Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing inflammatory conditions that usually affect the colon and the small intestine. Between 30 to 45% of patients with IBD do not take their treatment as prescribed by their health care team (Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA) provides a theoretical framework to develop adherence interventions that are patient-centred (Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the medication but there are barriers beyond their control, such as not understanding the instructions (practical barriers). Intentional non-adherence is the result of the beliefs affecting the patient's motivation to continue with treatment (perceptual barriers).
Aims
Read more
- To develop an internet-based intervention to address perceptual and practical barriers to adherence to medicine for IBD.
- To determine whether the intervention is effective based on change in both types of barriers.
Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD; currently prescribed azathioprine, mesalazine, and/or adalimumab.
240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will take part in the study. An online pilot Randomised Controlled Trial will allocate the participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or Treatment as Usual group. On first visiting the website, participants will be screened for eligibility and asked for consent before answering the questionnaires. The website will assign intervention modules to be completed based on an individual's profile.
Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month follow-ups.
Potential Impact A CBT based online intervention tailored to personal needs and concerns may benefit a large number of patients with low costs for the national healthcare services. A website can be accessed at a time and place convenient to the patient.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.
- Keywords
- Inflammatory Bowel Disease (IBD), Crohn's disease, Ulcerative colitis, Cognitive Behavioural Therapy (CBT), Medication adherence
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.Behavioural
The general approach to the intervention is the following:
- Assess and profile individual perceptual and practical barriers to medication for IBD using validated questionnaires.
- Give feedback to individuals on their questionnaire responses.
- Provide individualised advice to address doubts, misconceptions and concerns for currently prescribed medications.
- Provide advice on overcoming practical barriers.
- Send motivational messages (and reminders if applicable) by email or text based on the unique profile of each participant.
- Provide information about how to raise concerns with medical practitioners and how to get the most from a medical consultation.
| Study group | Role | What they receive |
|---|---|---|
| CBT based online intervention | Experimental | CBT based online intervention to elicit and address perceptual and practical barriers to taking medication. Receives: Behavioral: CBT based online intervention to elicit and address perceptual and practical barriers to taking medication. |
| Control group | No intervention | Care as Usual. Participants in the control group will be able to access the online intervention after they complete their last follow-up questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beliefs about Medicines Questionnaire (BMQ)
The BMQ (Horne and Weinman, 1999) has been validated for use with people with chronic conditions. It comprises a scale that measures beliefs about medication prescribed specifically for IBD and a general scale that evaluates beliefs that medicines are harmful, addictive, poisons.
Measured: Baseline, 1 month follow-up, 3 month follow-up
Secondary outcomes (7)
Change in Medication Adherence Report Scale (MARS)
The MARS scale (Horne and Hankins 1997) is extensively used as a measure of adherent behaviours in a variant of illness populations. The MARS attempts to diminish the social pressure on patients to under-report non-adherence by phrasing adherence questions in a non-threatening manner and assuring them that responses are anonymous and confidential.
Measured: Baseline, 1 month follow-up, 3 month follow-up
Change in Hospital Anxiety and Depression questionnaire (HADS)
The HADS scale (Zigmond and Snaith 1983) is a reliable and valid instrument for detecting states of depression and anxiety.
Measured: Baseline, 1 month follow-up, 3 month follow-up
Change in Visual Analogue measure of adherence
Self-reported estimation of the % of medication taken over the last 4 weeks.
Measured: Baseline, 1 month follow-up, 3 month follow-up.
Change in Brief Illness Perception Questionnaire (IPQ)
The brief IPQ (Broadbent, Petrie et al. 2006) has demonstrated adequate test-retest reliability and validity.
Measured: Baseline, 1 month follow-up, 3 month follow-up.
Change in Satisfaction with Information about Medicines Scale (SIMS)
The SIMS scale (Horne, Hankins et al. 2001) is a valid and reliable instrument for assessing how well the needs for medicines information in patient are being covered.
Measured: Baseline, 1 month follow-up, 3 month follow-up
Change in Marlow-Crowne Social Desirability Scale-Form C (M-C Form C) (Reynolds 1982)
The Marlow-Crowne Social Desirability Scale-Form C (Reynolds 1982) is a measure of social desirability as a response tendency and it has been proved reliable and consistent (Nordholm 1974; Crino, Rubenfeld et al. 1985; Barger 2002).
Measured: Baseline, 1 month follow-up, 3 month follow-up
Change in Short Inflammatory Bowel Disease Questionnaire
The SIBDQ is a valid and reliable tool able to detect meaningful clinical changes in the health related quality of life of individuals with both Crohn's disease and Ulcerative colitis. It measures physical, social, and emotional status (the scores go from 10 to 70, poor to good quality of life).
Measured: Baseline, 1 month follow-up, 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852097
- Sponsor's protocol ID
- 12/0210
- Status last verified
- Feb 2013
- First submitted
- 11 Oct 2012
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Trial to Determine the Feasibility, Acceptability and Effectiveness of a CBT Based Online Intervention to Address Practical and Perceptual Barriers to Medication Adherence in Inflammatory Bowel Disease.
- ClinicalTrials.gov ID
- NCT01852097
- Acronym / sponsor ID
- 12/0210
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Inflammatory Bowel Disease (IBD), Crohn's disease, Ulcerative colitis, Cognitive Behavioural Therapy (CBT), Medication adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing inflammatory conditions that usually affect the colon and the small intestine. Between 30 to 45% of patients with IBD do not take their treatment as prescribed by their health care team (Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA) provides a theoretical framework to develop adherence interventions that are patient-centred (Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the medication but there are barriers beyond their control, such as not understanding the instructions (practical barriers). Intentional non-adherence is the result of the beliefs affecting the patient's motivation to continue with treatment (perceptual barriers).
Aims
- To develop an internet-based intervention to address perceptual and practical barriers to adherence to medicine for IBD.
- To determine whether the intervention is effective based on change in both types of barriers.
Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD; currently prescribed azathioprine, mesalazine, and/or adalimumab.
240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will take part in the study. An online pilot Randomised Controlled Trial will allocate the participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or Treatment as Usual group. On first visiting the website, participants will be screened for eligibility and asked for consent before answering the questionnaires. The website will assign intervention modules to be completed based on an individual's profile.
Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month follow-ups.
Potential Impact A CBT based online intervention tailored to personal needs and concerns may benefit a large number of patients with low costs for the national healthcare services. A website can be accessed at a time and place convenient to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT based online intervention | Experimental | Behavioral: CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.CBT based online intervention to elicit and address perceptual and practical barriers to taking medication. |
| Control group | No intervention | –Care as Usual. Participants in the control group will be able to access the online intervention after they complete their last follow-up questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or over.
- Diagnosis of IBD (Crohn's Disease or Ulcerative Colitis or Indeterminate Colitis).
- Currently prescribed one or more of the following medications for IBD: azathioprine, mesalazine, and adalimumab.
Key exclusion criteria (2 listed)
- We will exclude people who are for any reason unable to make an informed decision about taking part and people who do not wish to complete follow-up questionnaires.
- People who declare that they do not understand written English. This is a pilot feasibility study that aims to assess the effectiveness and acceptability of an online CBT based intervention in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.The general approach to the intervention is the following: 1. Assess and profile individual perceptual and practical barriers to medication for IBD using validated questionnaires. 2. Give feedback to individuals on their questionnaire responses. 3. Provide individualised advice to address doubts, misconceptions and concerns for currently prescribed medications. 4. Provide advice on overcoming practical barriers. 5. Send motivational messages (and reminders if applicable) by email or text based on the unique profile of each participant. 6. Provide information about how to raise concerns with medical practitioners and how to get the most from a medical consultation. | Behavioural | CBT based online intervention |
Primary outcome
Change in Beliefs about Medicines Questionnaire (BMQ)
Time frame: Baseline, 1 month follow-up, 3 month follow-up
The BMQ (Horne and Weinman, 1999) has been validated for use with people with chronic conditions. It comprises a scale that measures beliefs about medication prescribed specifically for IBD and a general scale that evaluates beliefs that medicines are harmful, addictive, poisons.
7 secondary outcomes
Change in Medication Adherence Report Scale (MARS)
Time frame: Baseline, 1 month follow-up, 3 month follow-up
Change in Hospital Anxiety and Depression questionnaire (HADS)
Time frame: Baseline, 1 month follow-up, 3 month follow-up
Change in Visual Analogue measure of adherence
Time frame: Baseline, 1 month follow-up, 3 month follow-up.
Change in Brief Illness Perception Questionnaire (IPQ)
Time frame: Baseline, 1 month follow-up, 3 month follow-up.
Change in Satisfaction with Information about Medicines Scale (SIMS)
Time frame: Baseline, 1 month follow-up, 3 month follow-up
Change in Marlow-Crowne Social Desirability Scale-Form C (M-C Form C) (Reynolds 1982)
Time frame: Baseline, 1 month follow-up, 3 month follow-up
Change in Short Inflammatory Bowel Disease Questionnaire
Time frame: Baseline, 1 month follow-up, 3 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
- Derived from this study: PubMed 40243391Tiles-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.
- SponsorLink provided by the sponsor.
- UCL School of Pharmacy official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing CBT based online intervention to elicit and address perceptual and practical barriers to taking medication. in people with Inflammatory Bowel Disease (IBD), run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Sibelli, MSc. Health Psychology (+44(0)20 7874 1282, a.sibelli@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beliefs about Medicines Questionnaire (BMQ) (time frame: Baseline, 1 month follow-up, 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.