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NCT05140551 | Completed | Diabetes Mellitus

Emotional Wellbeing in Diabetes
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).

Condition or disease

Diabetes Mellitus

Diabetes Mellitus, Type 2

Diabetes Mellitus, Type 1

Diabetes

Depression

Anxiety

Distress, Emotional

Diabetes Distress

Loneliness

Social Functioning

Quality of Life

Intervention/treatment

COMPASS: digital CBT

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 12 participants
Masking : None (Open Label)
Primary Purpose : Health Services Research
Official Title : Investigating the Care That People With Diabetes Receive for Their Emotional Wellbeing
Actual Study Start Date : April 6, 2022
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : July 1, 2023
Arm Intervention/treatment

Experimental: COMPASS

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

Device: COMPASS: digital CBT
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
    • Emotional Wellbeing in Diabetes

    Location Details

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    Emotional Wellbeing in Diabetes

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United Kingdom, Other

    Guys Hospital

    London, Other, United Kingdom, CV31 2QE

    Not yet recruiting

    United Kingdom,

    Emma Jenkinson

    London, United Kingdom, Н19 ЧТА

    Not yet recruiting

    United Kingdom,

    King's College London

    London, United Kingdom, SE1 9RT

    Not yet recruiting

    United Kingdom,

    South London and Maudsley

    London, United Kingdom,