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Trial record 19 of 3120 for:    Mexico | Mexico

Intervention for Reducing Psychiatric Symptoms and Metabolic Variables in Patients With Diabetes Mellitus (DM) (DM)

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ClinicalTrials.gov Identifier: NCT02889172
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : September 7, 2016
Sponsor:
Collaborator:
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Valerio Villamil-Salcedo, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Brief Summary:
The purpose of this study is apply a Brief Intervention (PST) in Diabetic and Obesity patient in primary care of Mexico City to improve their depressive and anxious symptoms and stabilization of metabolic variables.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Problem Solving Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Brief Intervention for Reducing Depressive and Anxiety Symptoms and Their Impact on Metabolic Variables in Patients With Type II Diabetes Mellitus and Obesity
Study Start Date : February 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Problem Solving Therapy
Will be apply a Brief Intervention (PST) for patients with Type II Diabetes Mellitus and Obesity who receive treatment in primary care centers from Mexico City. The aim is evaluate if PST improvement the depressive and anxiety symptoms and help to adhere to treatment and stabilize their metabolic variables
Behavioral: Problem Solving Therapy
It will be apply a Brief Intervention (PST) for patients with Type II Diabetes Mellitus and Obesity who receive treatment in primary care centers from Mexico City to evaluate if PST improvement the depressive and anxiety symptoms and help to adhere to treatment and stabilize their metabolic variables

No Intervention: Control
This group will receive the usual treatment , without intervention with Brief Intervention ( PST )



Primary Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: Six months ]

    The Beck Depression Inventory is a questionnaire of 21 items , is a self- applied instrument ; and determines the severity of depression in a Likert scale ranging from 0 to 4 points ; the minimum score is 0 and the maximum of 63 points : 0-13 = minimal depression ; 14-19 = mild depression ; 20-28 = moderate depression ; 29-63 = severe depression .

    This instrument has been used in several international studies and in Mexico showing validity and reliability.



Secondary Outcome Measures :
  1. Beck Anxiety Inventory [ Time Frame: Six Months ]
    The Beck Anxiety Inventory is a semi-structured questionnaire, which applies as assessed clinical having the patient. It consists of 21 questions Likert from 0 to 4 points that assesses the severity of anxiety : 0-7 = minimal anxiety ; 8-15 = mild anxiety ; 16-25 = moderate anxiety ; 26-63 = severe anxiety. The questionnaire has been validated in international studies in Mexico and in clinical settings .

  2. Simplified Medication Adherence Questionnaire [ Time Frame: Six Months ]

    The SMAQ questionnaire was validated between 1998 and 1999 in Spanish population was treated with unboosted nelfinavir in patients with renal transplantation.

    It is a questionnaire to assess adherence to treatment consisting of 6 self-applied questions investigating different aspects of the phenomenon: a) oversights ; b ) times ; c ) adverse effects; d ) failure of the weekend ; e) quantification in the last week , and f ) quantification in the last quarter.




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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 35-70 years old
  2. Female and male
  3. Type II Diabetes Mellitus
  4. Obesity (BMI ≥ 30)
  5. K-10 ≥ 21 points
  6. Beck Depression Inventory 13 to ≤ 28 points
  7. Beck Anxiety Inventory 7 to ≤ 25 points
  8. Informed consent accepted and signed

Exclusion Criteria:

  1. Severe depression or suicidal ideation
  2. Type I Diabetes Mellitus

Elimination criteria

  1. Questionnaires and scales incomplete
  2. Two sessions of PST missing
  3. Exacerbation of depressive and / or anxious symptoms during the intervention or monitoring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889172


Contacts
Contact: Blanca Vargas, Ph D 0051(55)41605327 vargast@imp.edu.mx
Contact: Valerio Villamil, Master 0051(55)41605247 valemil_2000@yahoo.com

Locations
Mexico
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente Recruiting
Mexico city, Mexico, 14370
Contact: Valerio Villamil, Master    0051(55)41605247    valemil_2000@yahoo.com   
Sponsors and Collaborators
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Universidad Nacional Autonoma de Mexico
Investigators
Principal Investigator: Blanca Vargas, Ph D Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Responsible Party: Valerio Villamil-Salcedo, Master, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
ClinicalTrials.gov Identifier: NCT02889172     History of Changes
Other Study ID Numbers: SC-14-2411
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases