Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study (PNIT)
|ClinicalTrials.gov Identifier: NCT02536820|
Recruitment Status : Unknown
Verified August 2015 by Fundación Salutia.
Recruitment status was: Not yet recruiting
First Posted : September 1, 2015
Last Update Posted : September 1, 2015
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: psychoneuroimmune therapy Drug: Conventional treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2016|
Conventional treatment + PNIT
PNIT: Psychoneuroimmuno therapy Conventional treatment: Usual treatment that each diabetic patient recieved
Behavioral: psychoneuroimmune therapy
Other Name: Solarte Technique
Active Comparator: Conventional treatment
Conventional treatment: Usual treatment that each diabetic patient recieved
Drug: Conventional treatment
Actual diabetes treatment in each participant
- glycosylated hemoglobin (HbAc1 %) [ Time Frame: 3 months ]
- Adverse events [ Time Frame: 3 months ]
- Fasting Plasma Glucose (mmol/L) [ Time Frame: 3 months ]
- Quality of life in participants in each arm [ Time Frame: 3 months ]
- Follow-up lost [ Time Frame: 3 months ]