Back to resultsAcceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study (COMPASS-IBD)
Primary Purpose
IBD, Psychological Distress, Treatment of Illness-related Distress in IBD
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
COMPASS
Sponsored by
About this trial
This is an interventional treatment trial for IBD
Eligibility Criteria
PATIENT PARTICIPANTS
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Health Psychology SectionRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COMPASS (single arm)
Arm Description
Participants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of IBD.
Outcomes
Primary Outcome Measures
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
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.
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.
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.
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.
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.
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.
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.
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.
The proportion of IBD patients who show evidence of acute suicidal risk at screening
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.
Assessing clinical reach of the COMPASS intervention
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.
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.
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.
Change in Patient Health Questionnaire - (PHQ-9)
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression.
Change in Generalised Anxiety Disorder scale (GAD-7)
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
Change in EQ-5D-3L
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)
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)
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)
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)
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
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
Acceptance of illness. Min score = 0, Max = 40. Greater scores indicate higher levels of acceptance.
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.
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
Change in smoking status
Current smoking status, including amount of cigarettes consumed per day.
Change in alcohol consumption
Number of units drunk in the past week.
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.
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.
Change in IBD medication
Current medication and dose.
Change in IBD flares
Frequency and severity (4-point scale) of IBD flares
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.
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.
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.
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.
The adoption of routine screening and the COMPASS programme.
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)
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.
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
Exploration of the adoption of COMPASS
Patient adherence to online sessions
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.
Adherence defined as 3 calls/messages attended.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05330299
First Posted
March 18, 2022
Last Updated
December 9, 2022
Sponsor
King's College London
Collaborators
Guy's and St Thomas's NHS Foundation Trust, Crohn's and Colitis UK
1. Study Identification
Unique Protocol Identification Number
NCT05330299
Brief Title
Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study
Acronym
COMPASS-IBD
Official Title
Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Guy's and St Thomas's NHS Foundation Trust, Crohn's and Colitis UK
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBD, Psychological Distress, Treatment of Illness-related Distress in IBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will receive COMPASS as part of standard care.
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COMPASS (single arm)
Arm Type
Experimental
Arm Description
Participants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of IBD.
Intervention Type
Behavioral
Intervention Name(s)
COMPASS
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number and demographics of people who agree to and complete routine screening for psychological distress (including e-IMPARTS).
Description
Assessing clinical reach of routine screening and the COMPASS intervention
Time Frame
18 months
Title
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.
Description
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.
Time Frame
18 months
Title
The proportion of patients with IBD who report clinical levels of anxiety (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Description
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.
Time Frame
18 months
Title
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.
Description
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.
Time Frame
18 months
Title
The proportion of patients with IBD who report clinical levels of depression (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
Description
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.
Time Frame
18 months
Title
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
Description
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.
Time Frame
18 months
Title
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
Description
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.
Time Frame
18 months
Title
Descriptive statistics of functioning in IBD patients, using the Work and Social Adjustment Scale questionnaire measured as part of standard care / routine screening.
Description
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.
Time Frame
18 months
Title
Descriptive statistics of control of IBD in IBD patients, using the IBD control questionnaire measured as part of standard care / routine screening.
Description
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.
Time Frame
18 months
Title
The proportion of IBD patients who show evidence of acute suicidal risk at screening
Description
Assessing clinical reach of routine screening and the COMPASS intervention
Time Frame
18 months
Title
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.
Description
Assessing clinical reach of the COMPASS intervention
Time Frame
18 months
Title
The reasons for study ineligibility (descriptively).
Description
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.
Time Frame
18 months
Title
COMPASS engagement
Description
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.
Time Frame
18 months
Title
Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from pre- to post-treatment in IBD patients who receive COMPASS.
Description
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.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in Patient Health Questionnaire - (PHQ-9)
Description
Depression. Min score = 0, Max score = 27, with higher scores indicating greater depression.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in Generalised Anxiety Disorder scale (GAD-7)
Description
Anxiety. Min score = 0, Max score = 21, with higher scores indicating greater anxiety
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in EQ-5D-3L
Description
Quality of life. Min score = 5, Max score = 15 , with higher scores more problems in the scale dimensions.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in the The UK Inflammatory Bowel Disease Questionnaire (IBDQ-UK)
Description
IBD-related Quality of Life. Min score = 0, Max score = 96. Higher values indicate better quality of life.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in the Patient Global Impression Scales of Severity (PGI-S)
Description
Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in the Brief Illness Perception Questionnaire (BIPQ)
Description
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.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in the short Cognitive Behavioural Responses Questionnaire (CBRQ-short)
Description
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.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in the Chronic Disease Self-efficacy Scale
Description
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.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in the Acceptance of Chronic Health Conditions Scale
Description
Acceptance of illness. Min score = 0, Max = 40. Greater scores indicate higher levels of acceptance.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in Health Service Use Questionnaire
Description
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.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in Body Mass Index (BMI)
Description
Weight (in kg) and Height (in m) will be combined to calculate BMI (weight in kg / (height in m)^2
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in smoking status
Description
Current smoking status, including amount of cigarettes consumed per day.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in alcohol consumption
Description
Number of units drunk in the past week.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in the International Physical Activity Questionnaire
Description
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.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in IBD activity
Description
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.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in IBD medication
Description
Current medication and dose.
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
Change in IBD flares
Description
Frequency and severity (4-point scale) of IBD flares
Time Frame
At baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
The Patient Global Impression Scales of Severity (PGI-S)
Description
Perceived symptom severity. 1 item. Min = 0, Max = 3, with higher scores indicating greater perceived symptom severity.
Time Frame
Baseline, 12 weeks (post-therapy), 6 months (follow-up)
Title
The Patient Global Impression Scales of Improvement (PGI-I)
Description
Perceived symptom improvement. 1 item. Min = 0, Max = 6, with higher scores indicating greater perceived symptom deterioration.
Time Frame
12 weeks (post-therapy), 6 months (follow-up)
Title
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.
Description
Descriptive data pertaining to demographics and frequencies. These data will be used to establish the efficacy of treatment pathways for IBD patients.
Time Frame
18 months
Title
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.
Description
These data will be used to establish the efficacy of treatment pathways for IBD patients.
Time Frame
18 months
Title
The adoption of routine screening and the COMPASS programme.
Description
Qualitative exploration the perspectives of healthcare professionals (HCPs) and patients
Time Frame
For patients -12-weeks (post-therapy); For HCPs (over 18 months)
Title
Scores in the NoMAD (tool for measuring implementation processes) as rated by healthcare professionals (HCPs)
Description
23-item instrument for measuring implementation processes, organised by the Normalisation Process Theory framework.
Time Frame
18 months
Title
The number of patients who require digital support to use COMPASS.
Description
Exploration of the adoption of COMPASS
Time Frame
18 months
Title
The change in numbers on and duration of the wait-list to see clinical psychologist from pre- to post-COMPASS
Description
Exploration of the adoption of COMPASS
Time Frame
18 months
Title
Patient adherence to online sessions
Description
Adherence defined as 5 online sessions completed. Will be used to assess the implementation of COMPASS into the service.
Time Frame
12-weeks (post therapy)
Title
Number and duration of therapist calls attended.
Description
Adherence defined as 3 calls/messages attended.
Time Frame
12-weeks (post therapy)
Title
Drop out rate of COMPASS
Description
The number and proportion of patients that drop out of COMPASS will be recorded to assess the implementation of COMPASS into the service.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PATIENT PARTICIPANTS
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Jones, PhD
Phone
07411232532
Email
Annie.s.jones@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Harding, MSc
Email
sophie.1.harding@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rona Moss-Morris, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Psychology Section
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Seaton, Msc
Phone
0207 188 1189
Email
natasha.seaton@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Sophie Harding, MSc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
The data will only be available on request.
Learn more about this trial
Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study
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