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

NCT02536820 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2015-09-01

No results posted yet for this study

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

BEHAVIORAL

psychoneuroimmune therapy

DRUG

Conventional treatment

Actual diabetes treatment in each participant

Sponsors & Collaborators

  • Coomeva E.P.S

    collaborator UNKNOWN

  • Sinergia

    collaborator UNKNOWN

  • Fundación Salutia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02536820 on ClinicalTrials.gov