IBDCOMPASS-IBDNCT05330299
Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study
A study testing COMPASS in people with IBD and Psychological Distress, run by King's College London at 1 site in United Kingdom.
Trial summary
This study is a single-centre, interventional implementation and feasibility study. Patients in the IBD service will be able to access COMPASS, an online cognitive-behavioural therapy (CBT) programme, as part of standard care at Guy's and St Thomas's NHS Foundation Trust. COMPASS is an online program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD, Psychological Distress, Treatment of Illness-related Distress in IBD
- What is being tested?
- COMPASS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Dec 2022to 29 Feb 2024
- 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
- Aged 18 or over
- Have an IBD diagnosis
- Have English proficiency
- Have access to a computer
- Have mild to moderate symptoms of depression and/or anxiety (PHQ-9 score 5-19 and/or GAD-7 score 5-14, or PHQ-ADS score 10-29) or severe depression and/or anxiety (PHQ-9 score≥20 and/or GAD-7 score ≥15, or PHQ-ADS score ≥30 but no acute suicidal risk) and awaiting treatment from clinical psychologist as specified above.
- Have evidence of illness-related distress
Who cannot join
- Evidence of substance dependency, cognitive impairment, severe mental health conditions
- Evidence of acute suicidal risk PHQ-9 item-9 >1 and recent serious suicidal intent and/or planning
- Are receiving current psychological treatment or are on a wait-list to receive treatment within the study period (next 6 months)
- Have depression and/or anxiety unrelated to IBD (e.g. where disease long-standing/well-controlled unrelated to current presentation of distress)
- HEALTHCARE PROFESSIONAL PARTICIPANTS
- Work in the Gastroenterology IBD service at Guy's and St Thomas' Hospitals NHS Trust (GSTT).
- Have experience of either: i) Utilising the routine mental health screening tools ii) Assessing and triaging patients onto the COMPASS programme and/or iii) Providing therapist support to the users of COMPASS.
Trial locations and contacts
1 site in 1 country.
Sophie Harding, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Health Psychology Section
London, SE1 9RT
Natasha Seaton, Msc, 0207 188 1189, natasha.seaton@kcl.ac.uk
Sophie Harding, MSc
About this study
This study is a single-centre, interventional implementation and feasibility study.
Patients in the IBD service will be able to access COMPASS, an online cognitive-behavioural therapy (CBT) programme, as part of standard care at Guy's and St Thomas's NHS Foundation Trust.
COMPASS is an online program. It will consist of 11 online modules which target challenges associated with living with IBD (and other long-term conditions) and includes, amongst other things, psycho-education, patient examples, interactive tasks and goal setting. Participants are linked to a therapist; 'guide', who will provide 5-6 x 30 minute support sessions delivered fortnightly in the format preferred by the client (phone and/or in-site message).
- Being tested
- COMPASS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMPASSBehavioural
Participants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of long-term conditions. It consists of 11 online modules and is therapist-supported.
| Study group | Role | What they receive |
|---|---|---|
| COMPASS (single arm) | Experimental | Participants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of IBD. Receives: Behavioral: COMPASS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and demographics of people who agree to and complete routine screening for psychological distress (including e-IMPARTS).
Assessing clinical reach of routine screening and the COMPASS intervention
Measured: 18 months
The demographic characteristics of patients with IBD who report clinical levels of anxiety (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Assessing clinical reach of routine screening and the COMPASS intervention. Anxiety is measured with the Generalised Anxiety Disorder Scale (GAD-7). Min score = 0, Max score = 21, with higher scores indicating greater anxiety.
Measured: 18 months
The proportion of patients with IBD who report clinical levels of anxiety (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Assessing clinical reach of routine screening and the COMPASS intervention. Anxiety is measured with the Generalised Anxiety Disorder Scale (GAD-7). Min score = 0, Max score = 21, with higher scores indicating greater anxiety.
Measured: 18 months
The demographic characteristics of patients with IBD who report clinical levels of depression (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Assessing clinical reach of routine screening and the COMPASS intervention. Depression is measured with the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 27, with higher scores indicating greater depression.
Measured: 18 months
The proportion of patients with IBD who report clinical levels of depression (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Assessing clinical reach of routine screening and the COMPASS intervention. Depression is measured with the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 27, with higher scores indicating greater depression.
Measured: 18 months
The demographics of IBD patients who report clinical levels of psychological distress in the mild to moderate (PHQ-ADS distress score 10-29) and severe (PHQ-ADS distress score ≥30, but no acute suicidal risk) range at screening
Assessing clinical reach of routine screening and the COMPASS intervention. Psychological Distress is measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). The PHQ-ADS is a composite measure of Generalised Anxiety Disorder questionnaire (GAD-7) and Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.
Measured: 18 months
The proportion of IBD patients who report clinical levels of psychological distress in the mild to moderate (PHQ-ADS distress score 10-29) and severe (PHQ-ADS distress score ≥30, but no acute suicidal risk) range at screening
Assessing clinical reach of routine screening and the COMPASS intervention. Psychological Distress is measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). The PHQ-ADS is a composite measure of Generalised Anxiety Disorder questionnaire (GAD-7) and Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.
Measured: 18 months
Descriptive statistics of functioning in IBD patients, using the Work and Social Adjustment Scale questionnaire measured as part of standard care / routine screening.
Assessing clinical reach of routine screening and the COMPASS intervention. The Work and Social Adjustment Scale (WSAS) measures impaired functioning. Min score = 0, max score = 40, with higher scores indicating greater impaired functioning.
Measured: 18 months
Descriptive statistics of control of IBD in IBD patients, using the IBD control questionnaire measured as part of standard care / routine screening.
Assessing clinical reach of routine screening and the COMPASS intervention. The IBD control measures the extent to which patients have control over their IBD. Min score = 0, max score = 16, with higher scores indicating poorer control.
Measured: 18 months
The proportion of IBD patients who show evidence of acute suicidal risk at screening
Assessing clinical reach of routine screening and the COMPASS intervention
Measured: 18 months
The demographic and clinical characteristics, and proportion of IBD patients who meet inclusion criteria and are willing and able to engage in the COMPASS treatment.
Assessing clinical reach of the COMPASS intervention
Measured: 18 months
The reasons for study ineligibility (descriptively).
Assessing clinical reach of the COMPASS intervention. Descriptive data, specifically frequencies documenting the number of individuals who are willing to use COMPASS, reasons documented for ineligibility/non-uptake and the sociodemographic and clinical profile of eligible vs non-eligible of COMPASS.
Measured: 18 months
COMPASS engagement
Assessing clinical reach of the COMPASS intervention. Descriptive data regarding demographic and clinical characteristics of non-engagers, less-adherent users and adherent-users of COMPASS.
Measured: 18 months
Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from pre- to post-treatment in IBD patients who receive COMPASS.
The PHQ-ADS will be used to establish the efficacy of treatment pathways for IBD patients. It is a composite measure of the Generalised Anxiety Disorder questionnaire (GAD-7) and the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in Patient Health Questionnaire - (PHQ-9)
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in Generalised Anxiety Disorder scale (GAD-7)
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in EQ-5D-3L
Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in the The UK Inflammatory Bowel Disease Questionnaire (IBDQ-UK)
IBD-related Quality of Life. Min score = 0, Max score = 96. Higher values indicate better quality of life.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in the Patient Global Impression Scales of Severity (PGI-S)
Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in the Brief Illness Perception Questionnaire (BIPQ)
Illness perceptions. Questionnaire adapted to use first 8 items: illness consequences and timeline, the controllability of the illness personally and through treatment, illness identity, concerns, coherence, and the emotional-impact of the illness. Each item on the BIPQ is assessed as a separate construct (for each construct, min = 0, max = 10). Higher scores relate to stronger/greater illness perceptions.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in the short Cognitive Behavioural Responses Questionnaire (CBRQ-short)
Views and behaviours regarding symptoms. Only 3 subscales will be used: embarrassment avoidance (3 items), symptom focusing (3 items) and all-or-nothing behaviour (3 items) subscales. Min = 0, Max = 36. Higher scores indicate poorer cognitive and behavioural responses.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in the Chronic Disease Self-efficacy Scale
Disease self-efficacy. 9 sub-scales will be used: exercise regularly, get information about disease, obtain help from community, communicate with physician, manage disease in general, do chores, social/recreational activity, manage symptoms, control/manage depression. Min scores = 0, Max scores = 320. Higher scores indicate higher self-efficacy.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in the Acceptance of Chronic Health Conditions Scale
Acceptance of illness. Min score = 0, Max = 40. Greater scores indicate higher levels of acceptance.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in Health Service Use Questionnaire
4 service use items (GP, psychologist, emergency care, secondary care service) from the client service receipt inventory (CSRI) will be used. Frequency and duration of particular services will be recorded, from which a total time will be calculated. There is no maximum value. Higher scores indicate more health service time used.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in Body Mass Index (BMI)
Weight (in kg) and Height (in m) will be combined to calculate BMI (weight in kg / (height in m)^2
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in smoking status
Current smoking status, including amount of cigarettes consumed per day.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in alcohol consumption
Number of units drunk in the past week.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in the International Physical Activity Questionnaire
Physical activity. There are three subscales (vigorous activity, moderate activity and lower-level activity). Scores will be in minutes. Higher scores will indicate more physical activity performed.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in IBD activity
For Crohn's Disease patients: The Patient-Reported Outcomes for the Assessment of Crohn's Disease Activity (PRO-CD). The scale contains two sub-scales: 1) bowel signs and symptoms, 2) functional symptoms. Each scale is scored separately. There is no total score for the PRO-CD. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms.
For Ulcerative Colitis / unclassified patients: The Patient-Reported Outcomes for Assessment of Ulcerative Colitis (PRO-UC). The scale has 9-items and includes two scales: 1) Bowel signs/symptoms and 2) functional symptoms. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in IBD medication
Current medication and dose.
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Change in IBD flares
Frequency and severity (4-point scale) of IBD flares
Measured: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
The Patient Global Impression Scales of Severity (PGI-S)
Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.
Measured: Baseline, 12 weeks (post-therapy), 6 months (follow-up)
The Patient Global Impression Scales of Improvement (PGI-I)
Perceived symptom improvement. 1 item. Min = 0, Max = 6, with higher scores indicating greater perceived symptom deterioration.
Measured: 12 weeks (post-therapy), 6 months (follow-up)
The demographic characteristics of IBD patients who receive COMPASS while on the IBD psychology wait-list, but are removed from the wait-list at the end of COMPASS.
Descriptive data pertaining to demographics and frequencies. These data will be used to establish the efficacy of treatment pathways for IBD patients.
Measured: 18 months
The clinical characteristics of IBD patients who receive COMPASS while on the IBD psychology wait-list, but are removed from the wait-list at the end of COMPASS.
These data will be used to establish the efficacy of treatment pathways for IBD patients.
Measured: 18 months
The adoption of routine screening and the COMPASS programme.
Qualitative exploration the perspectives of healthcare professionals (HCPs) and patients
Measured: For patients -12-weeks (post-therapy); For HCPs (over 18 months)
Scores in the NoMAD (tool for measuring implementation processes) as rated by healthcare professionals (HCPs)
23-item instrument for measuring implementation processes, organised by the Normalisation Process Theory framework.
Measured: 18 months
The number of patients who require digital support to use COMPASS.
Exploration of the adoption of COMPASS
Measured: 18 months
The change in numbers on and duration of the wait-list to see clinical psychologist from pre- to post-COMPASS
Exploration of the adoption of COMPASS
Measured: 18 months
Patient adherence to online sessions
Adherence defined as 5 online sessions completed. Will be used to assess the implementation of COMPASS into the service.
Measured: 12-weeks (post therapy)
Number and duration of therapist calls attended.
Adherence defined as 3 calls/messages attended.
Measured: 12-weeks (post therapy)
Drop out rate of COMPASS
The number and proportion of patients that drop out of COMPASS will be recorded to assess the implementation of COMPASS into the service.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start2 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by King's 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will receive COMPASS as part of standard care.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Crohn's and Colitis UK
- Responsible party
- Sponsor
- Investigators
- Rona Moss-Morris, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330299
- Sponsor's protocol ID
- 312818
- Acronym
- COMPASS-IBD
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available on request from the corresponding author. The data will not be available publicly due to privacy or ethical restrictions.
Publications
Harding S, Singh H, Hulme K, Seaton N, Wroe A, Duff A, Hudson J, Moss-Morris R, Jones ASK. Using a Person-Centred Approach to Adapt a Digital Therapy for Inflammatory Bowel Disease (COMPASS-IBD). Health Expect. 2026 Aug;29(4):e70818. doi: 10.1111/hex.70818.
PubMed 42627217Jones ASK, Harding S, Seaton N, Hudson JL, Duff A, Wroe A, Singh H, Norton S, Picariello F, Moss-Morris R. A real-world longitudinal study implementing digital screening and treatment for distress in inflammatory bowel disease (IBD): The COMPASS-IBD study protocol. Contemp Clin Trials. 2024 Oct;145:107658. doi: 10.1016/j.cct.2024.107658. Epub 2024 Aug 8.
PubMed 39121990
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study
- ClinicalTrials.gov ID
- NCT05330299
- Acronym / sponsor ID
- COMPASS-IBD / 312818
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Crohn's and Colitis UK
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 15 Apr 2022 (actual)
- 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.
This study is a single-centre, interventional implementation and feasibility study.
Patients in the IBD service will be able to access COMPASS, an online cognitive-behavioural therapy (CBT) programme, as part of standard care at Guy's and St Thomas's NHS Foundation Trust.
COMPASS is an online program. It will consist of 11 online modules which target challenges associated with living with IBD (and other long-term conditions) and includes, amongst other things, psycho-education, patient examples, interactive tasks and goal setting. Participants are linked to a therapist; 'guide', who will provide 5-6 x 30 minute support sessions delivered fortnightly in the format preferred by the client (phone and/or in-site message).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive COMPASS as part of standard care.
| Arm | Type | Receives |
|---|---|---|
| COMPASS (single arm) | Experimental | Behavioral: COMPASSParticipants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of IBD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 or over
- Have an IBD diagnosis
- Have English proficiency
- Have access to a computer
- Have mild to moderate symptoms of depression and/or anxiety (PHQ-9 score 5-19 and/or GAD-7 score 5-14, or PHQ-ADS score 10-29) or severe depression and/or anxiety (PHQ-9 score≥20 and/or GAD-7 score ≥15, or PHQ-ADS score ≥30 but no acute suicidal risk) and awaiting treatment from clinical psychologist as specified above.
Key exclusion criteria (7 listed)
- Evidence of substance dependency, cognitive impairment, severe mental health conditions
- Evidence of acute suicidal risk PHQ-9 item-9 >1 and recent serious suicidal intent and/or planning
- Are receiving current psychological treatment or are on a wait-list to receive treatment within the study period (next 6 months)
- Have depression and/or anxiety unrelated to IBD (e.g. where disease long-standing/well-controlled unrelated to current presentation of distress)
- HEALTHCARE PROFESSIONAL PARTICIPANTS
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 |
|---|---|---|
| COMPASSParticipants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of long-term conditions. It consists of 11 online modules and is therapist-supported. | Behavioural | COMPASS (single arm) |
Primary outcome
The number and demographics of people who agree to and complete routine screening for psychological distress (including e-IMPARTS).
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention
The demographic characteristics of patients with IBD who report clinical levels of anxiety (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention. Anxiety is measured with the Generalised Anxiety Disorder Scale (GAD-7). Min score = 0, Max score = 21, with higher scores indicating greater anxiety.
The proportion of patients with IBD who report clinical levels of anxiety (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention. Anxiety is measured with the Generalised Anxiety Disorder Scale (GAD-7). Min score = 0, Max score = 21, with higher scores indicating greater anxiety.
The demographic characteristics of patients with IBD who report clinical levels of depression (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention. Depression is measured with the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 27, with higher scores indicating greater depression.
The proportion of patients with IBD who report clinical levels of depression (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention. Depression is measured with the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 27, with higher scores indicating greater depression.
The demographics of IBD patients who report clinical levels of psychological distress in the mild to moderate (PHQ-ADS distress score 10-29) and severe (PHQ-ADS distress score ≥30, but no acute suicidal risk) range at screening
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention. Psychological Distress is measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). The PHQ-ADS is a composite measure of Generalised Anxiety Disorder questionnaire (GAD-7) and Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.
The proportion of IBD patients who report clinical levels of psychological distress in the mild to moderate (PHQ-ADS distress score 10-29) and severe (PHQ-ADS distress score ≥30, but no acute suicidal risk) range at screening
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention. Psychological Distress is measured with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). The PHQ-ADS is a composite measure of Generalised Anxiety Disorder questionnaire (GAD-7) and Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.
Descriptive statistics of functioning in IBD patients, using the Work and Social Adjustment Scale questionnaire measured as part of standard care / routine screening.
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention. The Work and Social Adjustment Scale (WSAS) measures impaired functioning. Min score = 0, max score = 40, with higher scores indicating greater impaired functioning.
Descriptive statistics of control of IBD in IBD patients, using the IBD control questionnaire measured as part of standard care / routine screening.
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention. The IBD control measures the extent to which patients have control over their IBD. Min score = 0, max score = 16, with higher scores indicating poorer control.
The proportion of IBD patients who show evidence of acute suicidal risk at screening
Time frame: 18 months
Assessing clinical reach of routine screening and the COMPASS intervention
The demographic and clinical characteristics, and proportion of IBD patients who meet inclusion criteria and are willing and able to engage in the COMPASS treatment.
Time frame: 18 months
Assessing clinical reach of the COMPASS intervention
The reasons for study ineligibility (descriptively).
Time frame: 18 months
Assessing clinical reach of the COMPASS intervention. Descriptive data, specifically frequencies documenting the number of individuals who are willing to use COMPASS, reasons documented for ineligibility/non-uptake and the sociodemographic and clinical profile of eligible vs non-eligible of COMPASS.
COMPASS engagement
Time frame: 18 months
Assessing clinical reach of the COMPASS intervention. Descriptive data regarding demographic and clinical characteristics of non-engagers, less-adherent users and adherent-users of COMPASS.
Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from pre- to post-treatment in IBD patients who receive COMPASS.
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
The PHQ-ADS will be used to establish the efficacy of treatment pathways for IBD patients. It is a composite measure of the Generalised Anxiety Disorder questionnaire (GAD-7) and the Patient Health Questionnaire (PHQ-9). Min score = 0, Max score = 48, with higher scores indicating higher levels of distress.
Change in Patient Health Questionnaire - (PHQ-9)
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression.
Change in Generalised Anxiety Disorder scale (GAD-7)
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
Change in EQ-5D-3L
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions.
Change in the The UK Inflammatory Bowel Disease Questionnaire (IBDQ-UK)
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
IBD-related Quality of Life. Min score = 0, Max score = 96. Higher values indicate better quality of life.
Change in the Patient Global Impression Scales of Severity (PGI-S)
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.
Change in the Brief Illness Perception Questionnaire (BIPQ)
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Illness perceptions. Questionnaire adapted to use first 8 items: illness consequences and timeline, the controllability of the illness personally and through treatment, illness identity, concerns, coherence, and the emotional-impact of the illness. Each item on the BIPQ is assessed as a separate construct (for each construct, min = 0, max = 10). Higher scores relate to stronger/greater illness perceptions.
Change in the short Cognitive Behavioural Responses Questionnaire (CBRQ-short)
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Views and behaviours regarding symptoms. Only 3 subscales will be used: embarrassment avoidance (3 items), symptom focusing (3 items) and all-or-nothing behaviour (3 items) subscales. Min = 0, Max = 36. Higher scores indicate poorer cognitive and behavioural responses.
Change in the Chronic Disease Self-efficacy Scale
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Disease self-efficacy. 9 sub-scales will be used: exercise regularly, get information about disease, obtain help from community, communicate with physician, manage disease in general, do chores, social/recreational activity, manage symptoms, control/manage depression. Min scores = 0, Max scores = 320. Higher scores indicate higher self-efficacy.
Change in the Acceptance of Chronic Health Conditions Scale
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Acceptance of illness. Min score = 0, Max = 40. Greater scores indicate higher levels of acceptance.
Change in Health Service Use Questionnaire
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
4 service use items (GP, psychologist, emergency care, secondary care service) from the client service receipt inventory (CSRI) will be used. Frequency and duration of particular services will be recorded, from which a total time will be calculated. There is no maximum value. Higher scores indicate more health service time used.
Change in Body Mass Index (BMI)
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Weight (in kg) and Height (in m) will be combined to calculate BMI (weight in kg / (height in m)^2
Change in smoking status
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Current smoking status, including amount of cigarettes consumed per day.
Change in alcohol consumption
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Number of units drunk in the past week.
Change in the International Physical Activity Questionnaire
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Physical activity. There are three subscales (vigorous activity, moderate activity and lower-level activity). Scores will be in minutes. Higher scores will indicate more physical activity performed.
Change in IBD activity
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
For Crohn's Disease patients: The Patient-Reported Outcomes for the Assessment of Crohn's Disease Activity (PRO-CD). The scale contains two sub-scales: 1) bowel signs and symptoms, 2) functional symptoms. Each scale is scored separately. There is no total score for the PRO-CD. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms. For Ulcerative Colitis / unclassified patients: The Patient-Reported Outcomes for Assessment of Ulcerative Colitis (PRO-UC). The scale has 9-items and includes two scales: 1) Bowel signs/symptoms and 2) functional symptoms. The first sub-scale starts at 0 and has no maximum value, with greater scores indicating greater bowel signs/symptoms. The second subscale ranges from 0-21, with higher scores indicating greater functional symptoms.
Change in IBD medication
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Current medication and dose.
Change in IBD flares
Time frame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Frequency and severity (4-point scale) of IBD flares
The Patient Global Impression Scales of Severity (PGI-S)
Time frame: Baseline, 12 weeks (post-therapy), 6 months (follow-up)
Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.
The Patient Global Impression Scales of Improvement (PGI-I)
Time frame: 12 weeks (post-therapy), 6 months (follow-up)
Perceived symptom improvement. 1 item. Min = 0, Max = 6, with higher scores indicating greater perceived symptom deterioration.
The demographic characteristics of IBD patients who receive COMPASS while on the IBD psychology wait-list, but are removed from the wait-list at the end of COMPASS.
Time frame: 18 months
Descriptive data pertaining to demographics and frequencies. These data will be used to establish the efficacy of treatment pathways for IBD patients.
The clinical characteristics of IBD patients who receive COMPASS while on the IBD psychology wait-list, but are removed from the wait-list at the end of COMPASS.
Time frame: 18 months
These data will be used to establish the efficacy of treatment pathways for IBD patients.
The adoption of routine screening and the COMPASS programme.
Time frame: For patients -12-weeks (post-therapy); For HCPs (over 18 months)
Qualitative exploration the perspectives of healthcare professionals (HCPs) and patients
Scores in the NoMAD (tool for measuring implementation processes) as rated by healthcare professionals (HCPs)
Time frame: 18 months
23-item instrument for measuring implementation processes, organised by the Normalisation Process Theory framework.
The number of patients who require digital support to use COMPASS.
Time frame: 18 months
Exploration of the adoption of COMPASS
The change in numbers on and duration of the wait-list to see clinical psychologist from pre- to post-COMPASS
Time frame: 18 months
Exploration of the adoption of COMPASS
Patient adherence to online sessions
Time frame: 12-weeks (post therapy)
Adherence defined as 5 online sessions completed. Will be used to assess the implementation of COMPASS into the service.
Number and duration of therapist calls attended.
Time frame: 12-weeks (post therapy)
Adherence defined as 3 calls/messages attended.
Drop out rate of COMPASS
Time frame: 18 months
The number and proportion of patients that drop out of COMPASS will be recorded to assess the implementation of COMPASS into the service.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 42627217Harding S, Singh H, Hulme K, Seaton N, Wroe A, Duff A, Hudson J, Moss-Morris R, Jones ASK. Using a Person-Centred Approach to Adapt a Digital Therapy for Inflammatory Bowel Disease (COMPASS-IBD). Health Expect. 2026 Aug;29(4):e70818. doi: 10.1111/hex.70818.
- Derived from this study: PubMed 39121990Jones ASK, Harding S, Seaton N, Hudson JL, Duff A, Wroe A, Singh H, Norton S, Picariello F, Moss-Morris R. A real-world longitudinal study implementing digital screening and treatment for distress in inflammatory bowel disease (IBD): The COMPASS-IBD study protocol. Contemp Clin Trials. 2024 Oct;145:107658. doi: 10.1016/j.cct.2024.107658. Epub 2024 Aug 8.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available on request from the corresponding author. The data will not be available publicly due to privacy or ethical restrictions.
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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.
Sophie Harding, MSc contact
Rona Moss-Morris, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMPASS in people with IBD and Psychological Distress, run by King's College London at 1 site in United Kingdom.
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 6 inclusion and 7 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 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Annie Jones, PhD (07411232532, Annie.s.jones@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and demographics of people who agree to and complete routine screening for psychological distress (including e-IMPARTS). (time frame: 18 months). The study lists 42 primary outcomes in all. 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 NCT05330299, which also lists 2 linked publications.
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 Dec 2022.