Clinical trial NCT05140551: Emotional Wellbeing in Diabetes
Official title: Investigating the Care That People With Diabetes Receive for Their Emotional Wellbeing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes
Depression
Anxiety
Distress, Emotional
Diabetes Distress
Loneliness
Social Functioning
Quality of Life
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2021-12-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility 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)

or

- 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.

Primary outcomes:
measure: To assess the socio-demographic and clinical reach of COMPASS.
timeFrame: To be collected throughout the study duration (the study will run for an average of 12 months).
measure: To assess the socio-demographic and clinical reach of COMPASS.
timeFrame: To be collected throughout the study duration (the study will run for an average of 12 months).
measure: To assess the socio-demographic and clinical reach of COMPASS.
timeFrame: To be collected throughout the study duration (the study will run for an average of 12 months).
measure: To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
timeFrame: To be collected at baseline, 12 weeks and 6 month follow up.
measure: To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
timeFrame: To be collected at baseline, 12 weeks and 6 month follow up.
measure: To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
timeFrame: To be collected at baseline, 12 weeks and 6 month follow up.
measure: To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
timeFrame: To be collected at baseline, 12 weeks and 6 month follow up.
measure: To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
timeFrame: To be collected at baseline, 12 weeks and 6 month follow up.
measure: To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
timeFrame: To be collected at baseline, 12 weeks and 6 month follow up.
measure: To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
timeFrame: To be collected at baseline, 12 weeks and 6 month follow up.
measure: To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported physical health outcomes (listed below).
timeFrame: To be collected at baseline, 12 weeks and 6 month follow up.
measure: To examine barriers and facilitators to the adoption of COMPASS from the perspective of both staff and patients.
timeFrame: To be collected at 12 weeks.
measure: To examine: i) number of patients who require digital support to use COMPASS ii) monthly referrals to COMPASS by staff.
timeFrame: To be collected at 12 weeks.
measure: To assess the implementation of COMPASS in terms of patient adherence to COMPASS online sessions and number and duration of therapist support calls attended.
timeFrame: To be collected throughout the study duration (the study will run for an average of 12 months).
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys Hospital
state: Other
city: London
country: United Kingdom
facility: Emma Jenkinson
city: London
country: United Kingdom
facility: King's College London
city: London
country: United Kingdom
facility: South London and Maudsley
Study officials:
References: