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
|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|
|Intervention Model:||Parallel Assignment|
|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|
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 )
- 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.
- 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 .
- 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.
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
|Contact: Blanca Vargas, Ph D||0051(55)firstname.lastname@example.org|
|Contact: Valerio Villamil, Master||0051(55)email@example.com|
|Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente||Recruiting|
|Mexico city, Mexico, 14370|
|Contact: Valerio Villamil, Master 0051(55)41605247 firstname.lastname@example.org|
|Principal Investigator:||Blanca Vargas, Ph D||Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente|