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| Name | Class |
|---|---|
| South London and Maudsley NHS Foundation Trust | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMPASS | Experimental | This is a single arm study. We are investigating COMPASS digital CBT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMPASS: digital CBT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the socio-demographic and clinical reach of COMPASS. | 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 be collected throughout the study duration (the study will run for an average of 12 months). |
| To assess the socio-demographic and clinical reach of COMPASS. | Descriptive data on the types of treatment individuals with diabetes received throughout the study. | To be collected throughout the study duration (the study will run for an average of 12 months). |
| To assess the socio-demographic and clinical reach of COMPASS. | Descriptive data documenting the number of individuals who consent to be contacted about research and subsequently give informed consent. The investigators will also report reasons for non-consent where this is disclosed. | To be collected throughout the study duration (the study will run for an average of 12 months). |
| To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below). | - General psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) | To be collected at baseline, 12 weeks and 6 month follow up. |
| To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below). | - Depression: Patient health Questionnaire -9 (PHQ-9). | To be collected at baseline, 12 weeks and 6 month follow up. |
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IAPT (primary care recruitment)
Patients will be eligible for inclusion if they are:
GSTT (Secondary care recruitment)
The same criteria will be applied as above but with the additional criteria in place:
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys Hospital | London | Other | CV31 2QE | United Kingdom | ||
| Emma Jenkinson |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D012917 | Social Adjustment |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
|
| To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below). |
- Anxiety: Generalised anxiety disorder assessment-7 (GAD-7) |
| To be collected at baseline, 12 weeks and 6 month follow up. |
| To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below). | - Diabetes distress: Diabetes distress scale -17 (DDS-17) | To be collected at baseline, 12 weeks and 6 month follow up. |
| To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below). | - Loneliness: The revised University of California Los Angeles Loneliness scale (UCLA-R) | To be collected at baseline, 12 weeks and 6 month follow up. |
| To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below). | - Social Functioning: The Work and Social Adjustment Scale (WSAS) | To be collected at baseline, 12 weeks and 6 month follow up. |
| To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below). | - Health Related Quality of Life: The European Quality of Life scale (EQ-5D-3L) | To be collected at baseline, 12 weeks and 6 month follow up. |
| To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported physical health outcomes (listed below). | - Glycaemic control: self-reported HbA1c levels. | To be collected at baseline, 12 weeks and 6 month follow up. |
| To examine barriers and facilitators to the adoption of COMPASS from the perspective of both staff and patients. | 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 be collected at 12 weeks. |
| To examine: i) number of patients who require digital support to use COMPASS ii) monthly referrals to COMPASS by staff. | 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 be collected at 12 weeks. |
| To assess the implementation of COMPASS in terms of patient adherence to COMPASS online sessions and number and duration of therapist support calls attended. | Descriptive data on number of online sessions completed and number and duration of therapist support calls attended will be extracted from the COMPASS program. | To be collected throughout the study duration (the study will run for an average of 12 months). |
| London |
| N19 4TA |
| United Kingdom |
| King's College London | London | SE1 9RT | United Kingdom |
| South London and Maudsley | London | United Kingdom |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |