Emotional Wellbeing in Diabetes

Not Applicable

Completed

• Conditions: Diabetes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Anxiety; Distress, Emotional; Diabetes Mellitus, Type 1; Social Functioning; Quality of Life; Depression; Diabetes Distress

• Registration Number: NCT05140551
• Lead Sponsor: King's College London

Brief Summary

The investigators want to understand the feasibility and acceptability of implementing COMPASS: Online Cognitive behavioural therapy (CBT) in routine NHS care for individuals with diabetes. People with type 1 or type 2 diabetes with co-morbid psychological distress will be invited to take part in a pre-post implementation study of COMPASS: Online CBT for managing depression and anxiety in context of Long-Term conditions (LTCs). Patients with diabetes who are also experiencing depression and/or anxiety and/or diabetes specific distress will be recruited from: Improving Access to Psychological therapies (IAPT) services or clinics within Guys and St Thomas National Health Service (NHS) trust (GSTT) in London, United Kingdom (UK).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-01
• Study Start: 2022-04-06
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the socio-demographic and clinical reach of COMPASS.	To be collected throughout the study duration (the study will run for an average of 12 months).	Descriptive data documenting the number of individuals who consent to be contacted about research and subsequently give informed consent. The investigators will also report reasons for non-consent where this is disclosed.
To examine: i) number of patients who require digital support to use COMPASS ii) monthly referrals to COMPASS by staff.	To be collected at 12 weeks.	The investigators will use descriptive statistics to quantify the number of patients who require digital support to use COMPASS and ii) monthly referrals to COMPASS by staff.
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).	To be collected at baseline, 12 weeks and 6 month follow up.	- Health Related Quality of Life: The European Quality of Life scale (EQ-5D-3L)
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported physical health outcomes (listed below).	To be collected at baseline, 12 weeks and 6 month follow up.	- Glycaemic control: self-reported HbA1c levels.
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).	To be collected at baseline, 12 weeks and 6 month follow up.	- Diabetes distress: Diabetes distress scale -17 (DDS-17)
To examine barriers and facilitators to the adoption of COMPASS from the perspective of both staff and patients.	To be collected at 12 weeks.	Semi-structured interviews will be conducted to explore patient and health care professional (HCP) perceptions of the barriers and facilitators of using COMPASS in the context of diabetes.
To assess the implementation of COMPASS in terms of patient adherence to COMPASS online sessions and number and duration of therapist support calls attended.	To be collected throughout the study duration (the study will run for an average of 12 months).	Descriptive data on number of online sessions completed and number and duration of therapist support calls attended will be extracted from the COMPASS program.

Trial Locations

Locations (4)

South London and Maudsley; 🇬🇧 London, United Kingdom

King's College London; 🇬🇧 London, United Kingdom

Emma Jenkinson; 🇬🇧 London, United Kingdom

Guys Hospital; 🇬🇧 London, Other, United Kingdom