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Emotional Wellbeing in Diabetes

Primary Purpose

Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
COMPASS: digital CBT
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COMPASS

Arm Description

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

Outcomes

Primary Outcome Measures

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 assess the socio-demographic and clinical reach of COMPASS.
Descriptive data on the types of treatment individuals with diabetes received throughout the study.
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 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 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 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 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 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 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 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 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 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 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 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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2021
Last Updated
April 6, 2022
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05140551
Brief Title
Emotional Wellbeing in Diabetes
Official Title
Investigating the Care That People With Diabetes Receive for Their Emotional Wellbeing
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes, Depression, Anxiety, Distress, Emotional, Diabetes Distress, Loneliness, Social Functioning, Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COMPASS
Arm Type
Experimental
Arm Description
This is a single arm study. We are investigating COMPASS digital CBT.
Intervention Type
Device
Intervention Name(s)
COMPASS: digital CBT
Other Intervention Name(s)
COMPASS: Navigating your long-term condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the socio-demographic and clinical reach of COMPASS.
Description
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.
Time Frame
To be collected throughout the study duration (the study will run for an average of 12 months).
Title
To assess the socio-demographic and clinical reach of COMPASS.
Description
Descriptive data on the types of treatment individuals with diabetes received throughout the study.
Time Frame
To be collected throughout the study duration (the study will run for an average of 12 months).
Title
To assess the socio-demographic and clinical reach of COMPASS.
Description
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.
Time Frame
To be collected throughout the study duration (the study will run for an average of 12 months).
Title
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
Description
- General psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
Time Frame
To be collected at baseline, 12 weeks and 6 month follow up.
Title
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
Description
- Depression: Patient health Questionnaire -9 (PHQ-9).
Time Frame
To be collected at baseline, 12 weeks and 6 month follow up.
Title
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
Description
- Anxiety: Generalised anxiety disorder assessment-7 (GAD-7)
Time Frame
To be collected at baseline, 12 weeks and 6 month follow up.
Title
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
Description
- Diabetes distress: Diabetes distress scale -17 (DDS-17)
Time Frame
To be collected at baseline, 12 weeks and 6 month follow up.
Title
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
Description
- Loneliness: The revised University of California Los Angeles Loneliness scale (UCLA-R)
Time Frame
To be collected at baseline, 12 weeks and 6 month follow up.
Title
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
Description
- Social Functioning: The Work and Social Adjustment Scale (WSAS)
Time Frame
To be collected at baseline, 12 weeks and 6 month follow up.
Title
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
Description
- Health Related Quality of Life: The European Quality of Life scale (EQ-5D-3L)
Time Frame
To be collected at baseline, 12 weeks and 6 month follow up.
Title
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported physical health outcomes (listed below).
Description
- Glycaemic control: self-reported HbA1c levels.
Time Frame
To be collected at baseline, 12 weeks and 6 month follow up.
Title
To examine barriers and facilitators to the adoption of COMPASS from the perspective of both staff and patients.
Description
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.
Time Frame
To be collected at 12 weeks.
Title
To examine: i) number of patients who require digital support to use COMPASS ii) monthly referrals to COMPASS by staff.
Description
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.
Time Frame
To be collected at 12 weeks.
Title
To assess the implementation of COMPASS in terms of patient adherence to COMPASS online sessions and number and duration of therapist support calls attended.
Description
Descriptive data on number of online sessions completed and number and duration of therapist support calls attended will be extracted from the COMPASS program.
Time Frame
To be collected throughout the study duration (the study will run for an average of 12 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Jenkinson, MSc
Email
emma.jenkinson@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Joanna Hudson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotional Wellbeing in Diabetes

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