Diabetes MellitusNCT05140551
Emotional Wellbeing in Diabetes
A study testing COMPASS: digital CBT in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by King's College London at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- COMPASS: digital CBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 6 Apr 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Guys Hospital
London, Other, CV31 2QE
Emma Jenkinson
London, N19 4TA
King's College London
London, SE1 9RT
South London and Maudsley
London
About this study
Official title: Investigating the Care That People With Diabetes Receive for Their Emotional Wellbeing
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
- Being tested
- COMPASS: digital CBT
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Depression, Anxiety Disorders, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMPASS: digital CBTDevice
Also called COMPASS: Navigating your long-term condition
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.
| Study group | Role | What they receive |
|---|---|---|
| COMPASS | Experimental | This is a single arm study. We are investigating COMPASS digital CBT. Receives: Device: COMPASS: digital CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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).
- Anxiety: Generalised anxiety disorder assessment-7 (GAD-7)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: To be collected throughout the study duration (the study will run for an average of 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start6 Apr 2022
- Primary completion1 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140551
- Sponsor's protocol ID
- 301444
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Care That People With Diabetes Receive for Their Emotional Wellbeing
- ClinicalTrials.gov ID
- NCT05140551
- Acronym / sponsor ID
- 301444
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMPASS | Experimental | Device: COMPASS: digital CBTThis is a single arm study. We are investigating COMPASS digital CBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMPASS: digital CBTAlso: COMPASS: Navigating your long-term conditionCOMPASS 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. | Device | COMPASS |
Primary outcome
To assess the socio-demographic and clinical reach of COMPASS.
Time frame: 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 assess the socio-demographic and clinical reach of COMPASS.
Time frame: To be collected throughout the study duration (the study will run for an average of 12 months).
Descriptive data on the types of treatment individuals with diabetes received throughout the study.
To assess the socio-demographic and clinical reach of COMPASS.
Time frame: To be collected throughout the study duration (the study will run for an average of 12 months).
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 explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
Time frame: 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 mental health outcomes (listed below).
Time frame: To be collected at baseline, 12 weeks and 6 month follow up.
- Depression: Patient health Questionnaire -9 (PHQ-9).
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
Time frame: To be collected at baseline, 12 weeks and 6 month follow up.
- Anxiety: Generalised anxiety disorder assessment-7 (GAD-7)
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
Time frame: To be collected at baseline, 12 weeks and 6 month follow up.
- Diabetes distress: Diabetes distress scale -17 (DDS-17)
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
Time frame: 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 psychosocial outcomes (listed below).
Time frame: To be collected at baseline, 12 weeks and 6 month follow up.
- Social Functioning: The Work and Social Adjustment Scale (WSAS)
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
Time frame: To be collected at baseline, 12 weeks and 6 month follow up.
- Health Related Quality of Life: The European Quality of Life scale (EQ-5D-3L)
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported physical health outcomes (listed below).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMPASS: digital CBT in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by King's College London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the socio-demographic and clinical reach of COMPASS. (time frame: To be collected throughout the study duration (the study will run for an average of 12 months).). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.