Emotional Wellbeing in Diabetes

Depression Clinical Trial

Official title:

Investigating the Care That People With Diabetes Receive for Their Emotional Wellbeing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140551
• Other study ID #: 301444
• Status: Completed
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Diabetes
• Diabetes Distress
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Distress, Emotional
• Loneliness
• Quality of Life
• Social Functioning

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Emma Jenkinson	London
United Kingdom	Guys Hospital	London	Other
United Kingdom	King's College London	London
United Kingdom	South London and Maudsley	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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).