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Completed

NCT Number: NCT03066570

Graded Exposure in Patients With Painful Diabetic Neuropathy

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.

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Key information

Conditions

Painful Diabetic Neuropathy Anxiety Disorders Behavior Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathies, Painful Endocrine System Diseases Mental Disorders Motor Activity Nervous System Diseases Neuralgia, Diabetic Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with type II diabetes mellitus,
  • aged > 18 years who suffer from peripheral polyneuropathy.

Exclusion criteria

  • Patients with lower limb morbidities other than PDN such as peripheral arterial disease
  • severe osteoarthritis, any other neurological disease than PDN or any other disease that may cause pain in the feet and/or damage to the peripheral nervous system (e.g. ulcers).

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Acronym: PDN&GEXP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2017
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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