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Evaluating a diabetes-specific online cognitive behavioural therapy intervention

A pre-post intervention study to investigate the effectiveness of diabetes specific online therapist delivered cognitive behavioural therapy for patients with Type 2 diabetes and with a comorbid axis I disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86160989
Enrollment
500
Registered
2018-10-22
Start date
2019-12-01
Completion date
Unknown
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes with co-morbid anxiety disorder and/or depression Nutritional, Metabolic, Endocrine Type 2 Diabetes with co-morbid anxiety disorder and/or depression

Interventions

Participants will receive an evidence-based cognitive behavioural therapy (CBT) treatment which will consist of weekly therapy appointments lasting 60 minutes. CBT will be delivered online, using sync

Sponsors

Roche Diabetes Care Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Diagnosed with type 2 diabetes at least 12 months prior 3. Co-morbid anxiety disorder and/or depression

Exclusion criteria

Exclusion criteria: 1. Unsuitable for cognitive behavioural therapy 2. Unable to access an Internet-enabled device or no access to an Internet connection 3. Low level of literacy 4. Visually impaired and unable to write on or read from a computer, and unable to access appropriate assistive technology for the visually impaired 5. Unable to speak English 6. Unsuitable for treatment within a primary care psychological therapy service: 6.1. Patients who become actively suicidal or present as a risk to others will be referred to a more specialised, secondary care service 6.2. Patients experiencing symptoms of psychosis, hypermania, severe cognitive impairment, severe personality disorders or a severe learning disability are also unsuitable for the study and will be referred to more specialised services 7. Already involved in a different research project 8. Undergoing any other mental health therapy at present

Design outcomes

Primary

MeasureTime frame
The following are assessed at the baseline, post-intervention and at the 6 months follow-up: 1. Depression, assessed using the Patient Health Questionnaire (PHQ-9) 2. Anxiety, assessed using the Generalised Anxiety Disorder Assessment (GAD-7)

Secondary

MeasureTime frame
The following are assessed at the baseline, post-intervention and at the 6 months follow-up: 1. Patient activation level and knowledge, skill and confidence in measuring their long-term health condition, assessed using the Patient Activation Measure (PAM) via telephone 2. Distress (emotional burden, regimen distress, interpersonal distress and physician distress), assessed using the Diabetes Distress Scale (DDS)

Countries

England, United Kingdom

Contacts

Public ContactAna Catarino
a.catarino@iesohealth.com+44 (0)800 074 5560

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026