Emotional Wellbeing in Diabetes

NCT ID: NCT05140551

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2023-07-01

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

COMPASS

This is a single arm study. We are investigating COMPASS digital CBT.

Group Type: EXPERIMENTAL

COMPASS: digital CBT

Intervention Type: DEVICE

COMPASS is an evidence based digital CBT intervention with guided therapist support, tailored to treat anxiety and/or depression in long term conditions (LTCs). The intervention consists of eleven modules/sessions in which CBT techniques are taught. Users of COMPASS receive guided therapist support from a trained therapist. The guided support aims to help patients identify and apply the CBT skills outlined in COMPASS to meet their individual needs and experiences of living with LTC(s). The support can occur through in-site messaging or via the telephone.

Interventions

COMPASS: digital CBT

COMPASS is an evidence based digital CBT intervention with guided therapist support, tailored to treat anxiety and/or depression in long term conditions (LTCs). The intervention consists of eleven modules/sessions in which CBT techniques are taught. Users of COMPASS receive guided therapist support from a trained therapist. The guided support aims to help patients identify and apply the CBT skills outlined in COMPASS to meet their individual needs and experiences of living with LTC(s). The support can occur through in-site messaging or via the telephone.

Intervention Type: DEVICE

Other Intervention Names

COMPASS: Navigating your long-term condition

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guys Hospital

London, Other, United Kingdom

Emma Jenkinson

London, , United Kingdom

King's College London

London, , United Kingdom

South London and Maudsley

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

301444

Identifier Type: -

Identifier Source: org_study_id