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

NCT02889172 | Terminated DMC

• 1 other identifier: SC-14-2411
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory

  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.

  Six months

Secondary Outcomes (2)

• Beck Anxiety Inventory

  Six Months

• Simplified Medication Adherence Questionnaire

  Six Months

Study Arms (2)

Problem Solving Therapy

EXPERIMENTAL

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

Control

NO INTERVENTION

This group will receive the usual treatment , without intervention with Brief Intervention ( PST )

Interventions

Problem Solving Therapy BEHAVIORAL

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

Problem Solving Therapy

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Female and male
• Type II Diabetes Mellitus
• Obesity (BMI ≥ 30)
• K-10 ≥ 21 points
• Beck Depression Inventory 13 to ≤ 28 points
• Beck Anxiety Inventory 7 to ≤ 25 points
• Informed consent accepted and signed

You may not qualify if:

• Severe depression or suicidal ideation
• Type I Diabetes Mellitus
• Elimination criteria
• Questionnaires and scales incomplete
• Two sessions of PST missing
• Exacerbation of depressive and / or anxious symptoms during the intervention or monitoring

Sponsors & Collaborators

• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: lead
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Mexico City, 14370, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: September 5, 2016
• Study Start: February 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

ME (1)