Cerebral mechanisms of acceptance and commitment therapy for neuropathic pain: a longitudinal randomised controlled neuroimaging trial

Not Applicable

• Conditions: Painful diabetic neuropathy (PDN); Nervous System Diseases

• Registration Number: ISRCTN18110844
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-16
• Last Update Posted: 21 December 2021
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age 18 years or older, who have normal or corrected to normal vision and hearing by having a visual acuity of at least decimal 0.5 (6/12) measured on the Snellen scale (e.g., without metal-rimmed glasses or hearing aids)
2. Willing to participate in the study and complete the scientific protocol
3. People with type 1 or type 2 diabetes, with a glycated hemoglobin (HbA1c) level =11% at the screening visit, will be considered eligible to participate in the study

Exclusion Criteria

1. Current or planned hospitalisation during the period of study
2. Patients not giving consent to participate
3. Patients who cannot communicate fluently in English
4. Unable, in the opinion of the research investigator, to comply or adhere to the requirements of the study. This may include, for example, an inability to understand the written documentation for the study
5. A history of serious head injury, brain surgery or brain injury
6. A history of neurological disease or psychiatric disorder which would negate involvement in the study. For example, Alzheimer's disease, Huntington’s Disease, Epilepsy, Parkinson Disease, large territory cerebrovascular accidents, severe depression, schizoaffective disorders, current under active therapy in psychiatric services
7. Patients that have any underlying medical condition that in the opinion of the investigator will interfere with the study findings. For example: Patients with renal impairment, or hypothyroidism or hyperthyroidism; patients with a previous or current problem of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, hepatitis B or C, HIV infection or peripheral neuropathy due to a non-diabetic cause; pregnant; patients participating in any other interventional research trial, will be excluded from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified