Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study

King's College London

Status: Unknown

Conditions: Treatment of Illness-related Distress in IBD; IBD; Psychological Distress

Treatments: Behavioral: COMPASS

Study type: Interventional

Funder types: Other

Identifiers

NCT05330299

312818

Details and patient eligibility

About

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).

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

COMPASS (single arm)

Experimental group

Description:

Participants will be treated with an online CBT program that is specifically tailored to illness-related distress in the context of IBD.

Treatment:

Behavioral: COMPASS