Coronary Heart Disease, Depression, Diabetes Mellitus Type 2
Conditions
Keywords
Depression, diabetes, Coronary heart disease, CBT, Cognitive behavioural therapy
Brief summary
A feasibility pilot trial of the self-help, Cognitive behavioural therapy based Living Life to the Full Materials for use by patients with diabetes type 2 and / or coronary heart disease.
Detailed description
Depressed mood is common in patients with chronic disease and physical disability. It adversely affects quality of life, adherence to treatment and clinical outcome. Depression is expensive to the person, their family, employers and society. Recent developments in the UK General Practitioners' Contract mean that patients with two chronic diseases (Coronary Heart Disease- CHD and Diabetes - DM) are routinely screened for depression using a simple screening tool. We propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way. This RCT is the second phase of a 2 phase mixed methods study examining the feasibility of a Full RCT. The first involved focus group with patients and health practitioners.
Interventions
BEHAVIORALLiving Life to the Full
A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats.
Sponsors
University of Stirling
Robert Gordon University
University of Glasgow
Chief Scientist Office of the Scottish Government
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease. * Be aged 35 or over. * Be attending a participating primary care practice. * Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44
Exclusion criteria
* Unable to provide informed consent to participate * Already receiving psychological treatment for their depression * Have commenced treatment with an SSRI within the past 8 weeks * Likely to have difficulty communicating by telephone * Likely to have difficulty completing the forms and questionnaires * Have a serious physical disorder * Have a serious mental disorder * Express significant suicidal thoughts (PHQ9 or BDI-2 question 9 scoring \>1) * Took part in an earlier related focus group
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients. | 13 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients would prefer or require a non-computerised treatment alternative to treatment (i.e. a book or DVD based form of the treatment). | 13 weeks |
| The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses. | 13 weeks |
| A change in depression (BDI-2), anxiety , social function (WASAS), quality of life (Euroqol 5D) or illness perception (IPQ-R) from participation in a self help programme. | 13 weeks |
Countries
United Kingdom
Outcome results
None listed