Telematic Program for the Treatment of Depression in Type 1 Diabetes

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status: Unknown

Conditions: Type 1 Diabetes Mellitus; Depression

Treatments: Behavioral: Control group (CG); Behavioral: Treatment group (TG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03473704

WEB_TDDI1 STUDY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Treatment group (TG)

Experimental group

Description:

The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.

Treatment:

Behavioral: Treatment group (TG)

Control group (CG)

Placebo Comparator group

Description:

The control group (CG) will be evaluated in the same phases as the TG.

Treatment:

Behavioral: Control group (CG)