Graded Exposure in Patients With Painful Diabetic Neuropathy (PDN&GEXP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03066570|
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : September 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Painful Diabetic Neuropathy Diabetic Neuropathies, Painful Neuralgia, Diabetic||Behavioral: Graded Exposure||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Randomized replicated sequential single-case design.|
|Masking:||None (Open Label)|
|Official Title:||Graded Exposure in Patients With Painful Diabetic Neuropathy|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
Experimental: Single case study
Single case study using Graded exposure.
Behavioral: Graded Exposure
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.
- Quality of Life as measured with Norfolk Quality of Life Questionnaire, Diabetic Neuropathy Version (Norfolk-QOL-DN) [ Time Frame: The primary outcome measure will be measured after 8 weeks of treatment with GEXP. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066570
|Contact: Charlotte Geelen, MDfirstname.lastname@example.org|
|Maastricht University Medical Center||Recruiting|
|Maastricht, Limburg, Netherlands, 6229HX|
|Contact: Charlotte Geelen, MD|
|Study Director:||Charlotte Geelen, MDemail@example.com|