Telematic Program for the Treatment of Depression in Type 1 Diabetes

March 21, 2018 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Assessment of the Effectiveness of a New Telematic Program for the Treatment of Depression in Patients With Type 1 Diabetes

In diabetes, web programs have been designed that have integrated cognitive-behavioral therapy (CBT) with diabetes education, obtaining positive results in the mood of the patient. In Spain, no similar approach has been performed in people with diabetes and depression. However, the need to provide professionals with adequate tools to help people with this problem is justified.

The main objective of this project is to apply a telematic program for the treatment of specific depression for people with type 1 diabetes designed by our research team in a sample of patients with type 1 diabetes and mild-moderate depressive symptomatology of the province of Malaga. To do this, the sample will be divided into two groups: treatment group (TG) and control group (CG). The design of the study is quasi-experimental, longitudinal randomized pre-post with control group. The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions, while the control group (CG) will be evaluated in the same phases as the TG. For ethical reasons, the CG will receive the web treatment once the TG intervention has been completed. There will be a follow-up at 3, 6 and 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

On the website will be collected the 9 sessions of which the treatment consists. The sessions will be weekly. Each week, the patient will find a brief summary of the previous session and an introduction to the topic, where the new session will be explained. Then, the patient will be provided with the new information (the topic treated) and different examples will be added to facilitate understanding. Once the information is presented, a summary of the key ideas of the session and a small evaluation to assess the understanding on the part of the patient will be presented. At the end of the session, the patient will have the key ideas and a self-evaluation of the session. Finally, the patient will be explained the task to be performed and sent to the therapist with an example of how to perform it. In addition, the patient will have a bibliography of each of the topics discussed. Each session will last 20-30 minutes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mónica Carreira, PhD
  • Phone Number: +34 952136697
  • Email: mcarreira@uma.es

Study Locations

  • Spain
      • Málaga, Spain, 29071
        • Recruiting
        • University of Malaga
        • Contact:
        • Contact:
          • Maria Teresa Anarte, PhD
          • Phone Number: +34 952132994
          • Email: anarte@uma.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a medical diagnosis of type 1 diabetes ≥1 year;
  • be over 18 years old;
  • have a psychological diagnosis of mild / moderate major depressive disorder, dysthymia or depressive symptomatology;
  • not have a concomitant pharmacological treatment that could modify the glycaemia values or the depressive symptomatology;
  • not be in previous psychological treatment;
  • absence of:
  • chronic renal failure,
  • impaired liver function tests,
  • active thyroid disease (except correctly substituted hypothyroidism),
  • gestation in progress;
  • absence of acute ketosis decompensation at the beginning of the study;
  • have access to the internet.

Exclusion Criteria:

  • Type 2 diabetes;
  • pregnant women or planning pregnancy;
  • severe macro or microvascular complications;
  • diagnosis of severe major depressive disorder with suicide risk;
  • no collaboration (no informed consent signature);
  • not have access to the internet;
  • present a disabling psychiatric disorder, psychosis, diagnosis of severe depressive disorder, suicidal ideation;
  • not have access to the internet.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group (TG)
The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
Behavioral: Treatment group (TG)
The Treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
Placebo Comparator: Control group (CG)
The control group (CG) will be evaluated in the same phases as the TG.
Behavioral: Control group (CG)
For ethical reasons, the CG will receive the web treatment once the TG intervention has been completed (as long as it continues to meet the conditions of the study).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5)
Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Depression symptoms
Time Frame: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Beck Depression Inventory-Fast Screen (BDI-FS)
Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fear of Hypoglycemia
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Fear of Hypoglycemia Scale (FH-15): 15 summable items assessed on a 5-point Likert scale with a range of 1-5. The cutoff score was set at 28 points. Individuals with scores equal to or greater than 28 points will be classified as having fear of hypoglycemia.
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Distress
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Diabetes Distress Scale (DDS): 17 items measure that uses a Likert scale to score each item from 1 (no problem) to 6 (a serious problem) during the last month. Based on four distress-related domains: emotional burden subscale, physician-related distress subscale, regimen-related distress subscale, and diabetes-related interpersonal distress.
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Quality of Life
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Diabetes Quality of Life Questionnaire (DQOL)
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Anxiety
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
The State-Trait Anxiety Inventory (STAI)
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Coping
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Coping Inventory (COPE)
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Personality
Time Frame: Pre treatment.
Millon Clinical Multiaxial Inventory (MCMI-III)
Pre treatment.
Adherence
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Self-Care Inventory-revised (SCI-R)
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Glycemic control
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Glycosylated hemoglobin test (HbA1c)
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Hypoglycemia
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Number of mild hypoglycemia weekly and severe hypoglycaemia in the last year.
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Hyperglycemia
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Number of hyperglycemia weekly.
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Ketone
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Number of ketone test positive in the last year.
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Blood glucose self-tests
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Number of blood glucose self-tests daily.
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Complications of diabetes
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Collect if there is any complication of diabetes in the patient's clinical history.
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Another disease
Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Collect if there is any illness (other than diabetes) diagnosed by the doctor in the patient's clinical history.
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Malaga

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: María Teresa Anarte, PhD, University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WEB_TDDI1 STUDY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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