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| ID | Type | Description | Link |
|---|---|---|---|
| MREC: 08/H0405/39 |
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| Name | Class |
|---|---|
| University of Stirling | OTHER |
| Robert Gordon University | OTHER |
| University of Glasgow | OTHER |
| Chief Scientist Office of the Scottish Government |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-help CBT | Experimental | A nurse supported self-help CBT intervention in addition to usual care. |
|
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Living Life to the Full | Behavioral | A nurse-supported, self-help, cognitive behavioural therapy with web, video and booklet formats. |
|
| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Maxwell, PhD | University of Stirling | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health and Social Care, Garthdee Campus, Robert Gordon University | Aberdeen | AB10 7QG | United Kingdom | |||
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003924 | Diabetes Mellitus, Type 2 |
| D003327 | Coronary Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| OTHER_GOV |
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| 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 |
| Community Health Sciences, GP Section, University of Edinburgh |
| Edinburgh |
| EH8 9DX |
| United Kingdom |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |