Anxiety, Depression, Diabetes, Diabetes Distress, Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Distress, Emotional, Loneliness, Quality of Life, Social Functioning
Conditions
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).
Interventions
DEVICECOMPASS: 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.
Sponsors
South London and Maudsley NHS Foundation Trust
King's College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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, specifically frequencies documenting the number of individuals who are willing to use COMPASS, reasons documented for ineligibility/non-uptake and the sociodemographic and clinical profile of users vs non-users of COMPASS. |
| 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. | \- General psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) |
| 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. | \- Loneliness: The revised University of California Los Angeles Loneliness scale (UCLA-R) |
| 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 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 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 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. |
Countries
United Kingdom
Outcome results
None listed