Emotional Wellbeing in Diabetes
Investigating the Care That People With Diabetes Receive for Their Emotional Wellbeing
1 other identifier
interventional
12
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Apr 2022
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
April 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedOctober 27, 2023
November 1, 2021
1.1 years
November 9, 2021
October 25, 2023
Conditions
Outcome Measures
Primary Outcomes (14)
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.
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).
Study Arms (1)
COMPASS
EXPERIMENTALThis is a single arm study. We are investigating COMPASS digital CBT.
Interventions
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.
Eligibility Criteria
You may not qualify if:
- 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)
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Guys Hospital
London, Other, CV31 2QE, United Kingdom
Emma Jenkinson
London, N19 4TA, United Kingdom
King's College London
London, SE1 9RT, United Kingdom
South London and Maudsley
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2021
First Posted
December 1, 2021
Study Start
April 6, 2022
Primary Completion
May 1, 2023
Study Completion
July 1, 2023
Last Updated
October 27, 2023
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share