Evaluating a diabetes-specific online cognitive behavioural therapy interventio

Not Applicable

Completed

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

• Registration Number: ISRCTN86160989
• Lead Sponsor: Roche Diabetes Care Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-22
• Study Completion: 2022-07-31
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 102

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> The following are assessed at the baseline, post-intervention and at the 6 months follow-up:<br> 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<br> 2. Distress (emotional burden, regimen distress, interpersonal distress and physician distress), assessed using the Diabetes Distress Scale (DDS)<br>