Telematic Program for the Treatment of Depression in Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-19

Study Completion Date

2020-10-01

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.

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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.

Conditions

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Type 1 Diabetes Mellitus Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Treatment group (TG)

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

Group Type EXPERIMENTAL

Treatment group (TG)

Intervention Type BEHAVIORAL

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

Control group (CG)

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

Group Type PLACEBO_COMPARATOR

Control group (CG)

Intervention Type BEHAVIORAL

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).

Interventions

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Treatment group (TG)

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

Intervention Type 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).

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No