Telematic Program for the Treatment of Depression in Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes Mellitus, Depression

Intervention / Treatment
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* Behavioral: Treatment group (TG)
* Behavioral: Control group (CG)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group (TG)<br>The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions. | Behavioral: Treatment group (TG)<br>* The Treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.<br>|
| Placebo Comparator: Control group (CG)<br>The control group (CG) will be evaluated in the same phases as the TG. | Behavioral: Control group (CG)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | 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 | Beck Depression Inventory-Fast Screen (BDI-FS) | Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Hypoglycemia | 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 | 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 | Diabetes Quality of Life Questionnaire (DQOL) | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Anxiety | The State-Trait Anxiety Inventory (STAI) | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Coping | Coping Inventory (COPE) | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Personality | Millon Clinical Multiaxial Inventory (MCMI-III) | Pre treatment. | 
| Adherence | Self-Care Inventory-revised (SCI-R) | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Glycemic control | Glycosylated hemoglobin test (HbA1c) | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Hypoglycemia | Number of mild hypoglycemia weekly and severe hypoglycaemia in the last year. | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Hyperglycemia | Number of hyperglycemia weekly. | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Ketone | Number of ketone test positive in the last year. | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Blood glucose self-tests | Number of blood glucose self-tests daily. | Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. | 
| Complications of diabetes | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, Depression, Telematic Program, Treatment, Web-based