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Telematic Program for the Treatment of Depression in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03473704
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
University of Malaga
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Depression Behavioral: Treatment group (TG) Behavioral: Control group (CG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Assessment of the Effectiveness of a New Telematic Program for the Treatment of Depression in Patients With Type 1 Diabetes
Actual Study Start Date : January 19, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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)

  2. Depression symptoms [ Time Frame: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    Beck Depression Inventory-Fast Screen (BDI-FS)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Quality of Life [ Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    Diabetes Quality of Life Questionnaire (DQOL)

  4. Anxiety [ Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    The State-Trait Anxiety Inventory (STAI)

  5. Coping [ Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    Coping Inventory (COPE)

  6. Personality [ Time Frame: Pre treatment. ]
    Millon Clinical Multiaxial Inventory (MCMI-III)

  7. Adherence [ Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    Self-Care Inventory-revised (SCI-R)

  8. Glycemic control [ Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    Glycosylated hemoglobin test (HbA1c)

  9. 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.

  10. Hyperglycemia [ Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    Number of hyperglycemia weekly.

  11. Ketone [ Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    Number of ketone test positive in the last year.

  12. Blood glucose self-tests [ Time Frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. ]
    Number of blood glucose self-tests daily.

  13. 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.

  14. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03473704


Contacts
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Contact: Mónica Carreira, PhD +34 952136697 mcarreira@uma.es

Locations
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Spain
University of Malaga Recruiting
Málaga, Spain, 29071
Contact: Mónica Carreira, PhD    +34 952136697    mcarreira@uma.es   
Contact: Maria Teresa Anarte, PhD    +34 952132994    anarte@uma.es   
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
University of Malaga
Investigators
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Principal Investigator: María Teresa Anarte, PhD University of Malaga

Publications:
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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT03473704     History of Changes
Other Study ID Numbers: WEB_TDDI1 STUDY
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
Type 1 diabetes
Depression
Telematic Program
Treatment
Web-based
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Autoimmune Diseases
Immune System Diseases