Clinical trial NCT05330299: Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study
Official title: Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IBD
Psychological Distress
Treatment of Illness-related Distress in IBD
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Crohn's and Colitis UK
First posted: 2022-04-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will receive COMPASS as part of standard care.
Primary purpose: TREATMENT

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).


Eligibility criteria: PATIENT PARTICIPANTS

Inclusion Criteria:

1. Aged 18 or over
2. Have an IBD diagnosis
3. Have English proficiency
4. Have access to a computer
5. 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.
6. Have evidence of illness-related distress

Exclusion Criteria:

1. Evidence of substance dependency, cognitive impairment, severe mental health conditions
2. Evidence of acute suicidal risk PHQ-9 item-9 \>1 and recent serious suicidal intent and/or planning
3. Are receiving current psychological treatment or are on a wait-list to receive treatment within the study period (next 6 months)
4. 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

1. Work in the Gastroenterology IBD service at Guy's and St Thomas' Hospitals NHS Trust (GSTT).
2. 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.

Primary outcomes:
measure: The number and demographics of people who agree to and complete routine screening for psychological distress (including e-IMPARTS).
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: The proportion of patients with IBD who report clinical levels of anxiety (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: The proportion of patients with IBD who report clinical levels of depression (according to IMPARTS pre-determined cut-offs) during routine mental health screening.
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: Descriptive statistics of functioning in IBD patients, using the Work and Social Adjustment Scale questionnaire measured as part of standard care / routine screening.
timeFrame: 18 months
measure: Descriptive statistics of control of IBD in IBD patients, using the IBD control questionnaire measured as part of standard care / routine screening.
timeFrame: 18 months
measure: The proportion of IBD patients who show evidence of acute suicidal risk at screening
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: The reasons for study ineligibility (descriptively).
timeFrame: 18 months
measure: COMPASS engagement
timeFrame: 18 months
measure: Change in Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from pre- to post-treatment in IBD patients who receive COMPASS.
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in Patient Health Questionnaire - (PHQ-9)
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in Generalised Anxiety Disorder scale (GAD-7)
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in EQ-5D-3L
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in the The UK Inflammatory Bowel Disease Questionnaire (IBDQ-UK)
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in the Patient Global Impression Scales of Severity (PGI-S)
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in the Brief Illness Perception Questionnaire (BIPQ)
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in the short Cognitive Behavioural Responses Questionnaire (CBRQ-short)
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in the Chronic Disease Self-efficacy Scale
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in the Acceptance of Chronic Health Conditions Scale
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in Health Service Use Questionnaire
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in Body Mass Index (BMI)
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in smoking status
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in alcohol consumption
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in the International Physical Activity Questionnaire
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in IBD activity
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in IBD medication
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: Change in IBD flares
timeFrame: At baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: The Patient Global Impression Scales of Severity (PGI-S)
timeFrame: Baseline, 12 weeks (post-therapy), 6 months (follow-up)
measure: The Patient Global Impression Scales of Improvement (PGI-I)
timeFrame: 12 weeks (post-therapy), 6 months (follow-up)
measure: 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.
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: The adoption of routine screening and the COMPASS programme.
timeFrame: For patients -12-weeks (post-therapy); For HCPs (over 18 months)
measure: Scores in the NoMAD (tool for measuring implementation processes) as rated by healthcare professionals (HCPs)
timeFrame: 18 months
measure: The number of patients who require digital support to use COMPASS.
timeFrame: 18 months
measure: The change in numbers on and duration of the wait-list to see clinical psychologist from pre- to post-COMPASS
timeFrame: 18 months
measure: Patient adherence to online sessions
timeFrame: 12-weeks (post therapy)
measure: Number and duration of therapist calls attended.
timeFrame: 12-weeks (post therapy)
measure: Drop out rate of COMPASS
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Health Psychology Section
Study officials:
affiliation: King's College London
name: Rona Moss-Morris, PhD
role: PRINCIPAL_INVESTIGATOR
References: