Diabetes Mellitus, Type 2DMNCT02889172
Intervention for Reducing Psychiatric Symptoms and Metabolic Variables in Patients With Diabetes Mellitus (DM)
A study testing Problem Solving Therapy in people with Diabetes Mellitus, Type 2, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Problem Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2015to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35-70 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Mexico City, 14370
About this study
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
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.
Read the detailed description
Diabetes and depression are chronic diseases that affect the quality of life of people and they increase disability and reduced life expectancy. The World Health Organization estimates there will be 300 million people with diabetes worldwide. The International Diabetes Federation warns that there are currently 382 million diabetics and may increase to 471 million in 2035 if it fails to make an international preventive action.
Furthermore, depression and anxiety disorders are the most common mental disorders worldwide. It is estimated that in 2030, depression will be the principal cause of all diseases worldwide; while anxiety disorders are related to other mental and medical conditions that prolong disability.
For these reasons, researchers have developed brief psychotherapeutic treatments with good results (Cognitive and Behavioural Therapy, Interpersonal therapy, and others) but with limitations due to lack of trained personnel for such interventions. However, the need for the care of people with diabetes with depression and anxiety symptoms are increasing, and pharmacological and therapeutic treatments are not enough. In other countries are using the Problem Solving Therapy (PST) as a brief technique to support the patient for possible solutions for daily problems which will generate emotional distress and depressive and anxiety symptoms. PST focuses on learning to cope with specific problems areas and where therapist and patient work collaboratively to identify and prioritise key problem areas, to break problems down into specific, manageable tasks, problem solve, and develop appropriate coping behaviours for problems. World Health Organization recommends the PST for depression treatment, which act "in the here and now" that helps identify a relationship between physical and emotional symptoms. Previous studies have shown the efficacy of the PST in reducing depressive and anxiety symptoms. The therapist may be a general practitioner, nurse, psychologist, social worker, etc., which serves as "advisor or counselor" while the patient is an active entity to solve their problems.
Objective The aim of this study is apply a Brief Intervention (PST) in Diabetic and Obesity patients in primary care centers of Mexico City to improve their depressive and anxious symptoms and assess their impact on treatment and stabilization of metabolic variables.
Method First Stage: Training medical students who are in last part of their education of medicine.
Second Stage: Application of brief intervention (PST) in patients with diagnosis of Diabetes and Obesity.
Stage Three: Analysis of results and publication of the study. Study design. A randomized, longitudinal, comparative clinical trial will be used.
Patients:
The study population will be 70 patients (35 experimental and 35 controls) of 11 primary care centers in Mexico City, with diagnosis of type II diabetes mellitus and / or obesity.
Inclusion criteria
- 35-70 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
Exclusion criteria
- Severe depression or suicidal ideation
- Type I Diabetes Mellitus
Procedure. Patients with K-10 ≥ 21 will invited to participate in the project; sign the informed consent and complete the Depression and Anxiety Beck Inventory; randomly, each subject will be assigned to the experimental or control group. Patients in the experimental group will receive the PST while the control group will receive usual treatment.
Metabolic variables: Glucose, weight, blood pressure, body mass index, total cholesterol, triglycerides and waist circumference at baseline, at 6 weeks and 4 months will be evaluated during the study.
Statistical Analysis. Percentages, means, standard deviation, Chi square, t student for independent samples and analysis of variance for repeated measures will be used.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Problem Solving Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Problem Solving Therapy |
| Control | No intervention | This group will receive the usual treatment , without intervention with Brief Intervention ( PST ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (2)
Beck Anxiety Inventory
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 .
Measured: Six Months
Simplified Medication Adherence Questionnaire
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.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico
- Responsible party
- Principal investigator, Valerio Villamil-Salcedo, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889172
- Sponsor's protocol ID
- SC-14-2411
- Acronym
- DM
- Status last verified
- Sep 2023
- First submitted
- 30 Apr 2015
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02889172
- Acronym / sponsor ID
- DM / SC-14-2411
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico
- Study start
- Feb 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetes and depression are chronic diseases that affect the quality of life of people and they increase disability and reduced life expectancy. The World Health Organization estimates there will be 300 million people with diabetes worldwide. The International Diabetes Federation warns that there are currently 382 million diabetics and may increase to 471 million in 2035 if it fails to make an international preventive action.
Furthermore, depression and anxiety disorders are the most common mental disorders worldwide. It is estimated that in 2030, depression will be the principal cause of all diseases worldwide; while anxiety disorders are related to other mental and medical conditions that prolong disability.
For these reasons, researchers have developed brief psychotherapeutic treatments with good results (Cognitive and Behavioural Therapy, Interpersonal therapy, and others) but with limitations due to lack of trained personnel for such interventions. However, the need for the care of people with diabetes with depression and anxiety symptoms are increasing, and pharmacological and therapeutic treatments are not enough. In other countries are using the Problem Solving Therapy (PST) as a brief technique to support the patient for possible solutions for daily problems which will generate emotional distress and depressive and anxiety symptoms. PST focuses on learning to cope with specific problems areas and where therapist and patient work collaboratively to identify and prioritise key problem areas, to break problems down into specific, manageable tasks, problem solve, and develop appropriate coping behaviours for problems. World Health Organization recommends the PST for depression treatment, which act "in the here and now" that helps identify a relationship between physical and emotional symptoms. Previous studies have shown the efficacy of the PST in reducing depressive and anxiety symptoms. The therapist may be a general practitioner, nurse, psychologist, social worker, etc., which serves as "advisor or counselor" while the patient is an active entity to solve their problems.
Objective The aim of this study is apply a Brief Intervention (PST) in Diabetic and Obesity patients in primary care centers of Mexico City to improve their depressive and anxious symptoms and assess their impact on treatment and stabilization of metabolic variables.
Method First Stage: Training medical students who are in last part of their education of medicine.
Second Stage: Application of brief intervention (PST) in patients with diagnosis of Diabetes and Obesity.
Stage Three: Analysis of results and publication of the study. Study design. A randomized, longitudinal, comparative clinical trial will be used.
Patients:
The study population will be 70 patients (35 experimental and 35 controls) of 11 primary care centers in Mexico City, with diagnosis of type II diabetes mellitus and / or obesity.
Inclusion criteria
- 35-70 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
Exclusion criteria
- Severe depression or suicidal ideation
- Type I Diabetes Mellitus
Procedure. Patients with K-10 ≥ 21 will invited to participate in the project; sign the informed consent and complete the Depression and Anxiety Beck Inventory; randomly, each subject will be assigned to the experimental or control group. Patients in the experimental group will receive the PST while the control group will receive usual treatment.
Metabolic variables: Glucose, weight, blood pressure, body mass index, total cholesterol, triglycerides and waist circumference at baseline, at 6 weeks and 4 months will be evaluated during the study.
Statistical Analysis. Percentages, means, standard deviation, Chi square, t student for independent samples and analysis of variance for repeated measures will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Therapy | Experimental | Behavioral: Problem Solving TherapyWill 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 |
| Control | No intervention | –This group will receive the usual treatment , without intervention with Brief Intervention ( PST ) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 35-70 years old
- Female and male
- Type II Diabetes Mellitus
- Obesity (BMI ≥ 30)
- K-10 ≥ 21 points
Key exclusion criteria (6 listed)
- Severe depression or suicidal ideation
- Type I Diabetes Mellitus
- Elimination criteria
- Questionnaires and scales incomplete
- Two sessions of PST missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving TherapyIt 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 | Behavioural | Problem Solving Therapy |
Primary outcome
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.
2 secondary outcomes
Beck Anxiety Inventory
Time frame: Six Months
Simplified Medication Adherence Questionnaire
Time frame: Six Months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy in people with Diabetes Mellitus, Type 2, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.