NCT02536820

Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Fundación Salutia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Psychoneuroimmunotherapy (PNIT) is the study, modification and implementation of the interactions between the processes of adaptive behavior, neurological, endocrine and immune. Among its premises assuming homeostasis or physiological balance as an integrated process involving the systems above mentioned. Additionally, among the basics theme the re-mean is introduced, ie changing the direction, the function of a concept from a negative context carry a positive meaning, so that from the PNIT no disease is seen as a problem but as a situation to solve. The patient then transmits the importance of which will come. Primary objective: To investigate whether patients on PNIT have a higher proportion of patients achieving disease control (\<7% in glycosylated hemoglobin (HBAC1) and quality of life compared with conventional treatment patients. Methodology: quasi-experimental, simple blind, simple blind, parallel, phase III clinical trial The investigators will follow a group of patients with type 2 diabetes mellitus durgin three months with an interim analysis a month after receiving the intervention (two visits) During each visit a trained PNIT physician assess the effectiveness, safety and quality of life of each patient. The investigators will include male or female patients aged 18 years-old with diabetes mellitus type II in any severity, uncontrolled (\> 7% Glycosilated Haemoglobin (HbAc1)) and any treatment regimen included. The patients are not allocated by a random process and the investigators will have a convenience sample The investigators will perform an intention to treat analysis, patients will be analyzed according to the intervention received even if this was different from the one they were assigned.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BEHAVIORAL	psychoneuroimmune therapy
DRUG	Conventional treatment	Actual diabetes treatment in each participant

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• First posted: 2015-09-01
• Last updated: 2015-09-01