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Objective: To investigate the effects of a cognitive behavioural intervention targeting specific fears in patients with painful diabetic neuropathy, on physical activity and quality of life.
Intervention: Graded Exposure in vivo (GEXP) is a second-generation cognitive-behavioural intervention, and is characterized by systematic and repeated exposure to feared movements, activities and/or sensations in order to decrease fear and subsequently increase physical activity.
Main study parameters/endpoints: The purpose of this project is to develop and test a cognitive behavioural intervention targeting specific fears in patients with PDN, in order to increase physical activity and improve QOL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single case study | Experimental | Single case study using Graded exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graded Exposure | Behavioral | Graded Exposure in vivo (GEXP) is a second-generation cognitive-behavioural intervention, and is characterized by systematic and repeated exposure to feared movements, activities and/or sensations in order to decrease fear and subsequently increase physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as measured with Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN) | Quality of life (QOL) will be measured using the 33-item Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN), a self-administered questionnaire designed to capture and quantify the perceived impact of diabetic neuropathy on the QOL, physical and psychosocial functioning of patients with diabetic neuropathy. | The primary outcome measure will be measured after 8 weeks of treatment with GEXP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Geelen, MD | charlotte.geelen@mumc.nl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229HX | Netherlands |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D009043 | Motor Activity |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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Randomized replicated sequential single-case design.
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|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D001523 | Mental Disorders |