Emotional Wellbeing in Diabetes

King's College London

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Diabetes

Quality of Life

Diabetes Mellitus

Loneliness

Social Functioning

Depression

Diabetes Mellitus, Type 2

Anxiety

Distress, Emotional

Diabetes Distress

Treatments

Device: COMPASS: digital CBT

Study type

Interventional

Funder types

Other

Identifiers

NCT05140551

301444

Details and patient eligibility

About

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).

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

IAPT (primary care recruitment)

Patients will be eligible for inclusion if they are:

Adults aged 18 or above.
Diagnosed with T1 diabetes or T2 diabetes
Have been self-referred/been referred to Southwark or Hackney (London) IAPT service for psychological support.
Speak English to a sufficiently high standard to allow them to interact with COMPASS.
Have access to the internet.

GSTT (Secondary care recruitment)

The same criteria will be applied as above but with the additional criteria in place:

Have psychological distress levels below the cut offs outlined by the service for face-to-face psychological treatment (see below for criteria):
(Diabetes Distress Scale (DDS-17) mean score <4

and/or

Patient Health Questionnaire (PHQ-9) score <19

and/or

Generalised Anxiety Disorder Scale (GAD-7 score) <15

AND

Diabetes Eating Problems Scale- Revised (DEPS-R) score <20)

Are deemed eligible for digital support by a clinician for patients who have not been assessed using mental health screening tools.

IAPT (primary care recruitment)

The following exclusion criteria will be applied:

Currently in receipt of psychological treatment for anxiety and/or depression.
Evidence of a severe mental health disorder (including bipolar disorder or psychosis) and/or alcohol and/or drug dependency identified by highly trained IAPT therapists as part of routine care.
Acute suicidal risk requiring a level of support that cannot be provided by therapists who are supporting patients remotely in their use of digital health interventions.

GSTT (secondary care recruitment)

As above but with the additional exclusion criteria below:

Evidence of a diabetes related eating disorder requiring a level of support that cannot be provided by therapists who are supporting patients remotely in their use of digital health interventions evidenced through a DEPS-R score of ≥20.

Eligibility criteria for the qualitative study - Qualitative Patient and healthcare professionals (HCP) interviews:

The investigators will interview participants who have experience of receiving COMPASS and those who do not uptake COMPASS.
The investigators also aim to interview participants who commenced COMPASS and subsequently dropped out of treatment.
The investigators will interview HCPs who have assessed and triaged patients for treatment, and those who have provided psychological support to individuals with diabetes.
Patients and HCPs will be purposively sampled to achieve a mix of age, gender, ethnicity, clinical variables and/or professional experience.