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Emotional Wellbeing in Diabetes

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ClinicalTrials.gov Identifier: NCT05140551
Recruitment Status : Completed
First Posted : December 1, 2021
Last Update Posted : October 27, 2023
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Study Description
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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 Intervention/treatment Phase
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Diabetes Depression Anxiety Distress, Emotional Diabetes Distress Loneliness Social Functioning Quality of Life Device: COMPASS: digital CBT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Actual Primary Completion Date : May 1, 2023
Actual Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: COMPASS
This is a single arm study. We are investigating COMPASS digital CBT.
 Device: COMPASS: 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.
Other Name: COMPASS: Navigating your long-term condition


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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).

  6. 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)

  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)

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  12. 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.

  13. 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.

  14. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05140551


Locations
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United Kingdom
Guys Hospital
London, Other, United Kingdom, CV31 2QE
Emma Jenkinson
London, United Kingdom, N19 4TA
King's College London
London, United Kingdom, SE1 9RT
South London and Maudsley
London, United Kingdom
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
More Information
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT05140551    
Other Study ID Numbers: 301444
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: October 27, 2023
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases