Telematic Program for the Treatment of Depression in Type 1 Diabetes
- Conditions
- DepressionType 1 Diabetes Mellitus
- Interventions
- Behavioral: Control group (CG)Behavioral: Treatment group (TG)
- Registration Number
- NCT03473704
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group (CG) Control group (CG) The control group (CG) will be evaluated in the same phases as the TG. Treatment group (TG) Treatment group (TG) The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
- Primary Outcome Measures
Name Time Method Depression 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)
Depression symptoms Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Beck Depression Inventory-Fast Screen (BDI-FS)
- Secondary Outcome Measures
Name Time Method Glycemic control Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Glycosylated hemoglobin test (HbA1c)
Hypoglycemia Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Number of mild hypoglycemia weekly and severe hypoglycaemia in the last year.
Hyperglycemia Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Number of hyperglycemia weekly.
Quality of Life Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Diabetes Quality of Life Questionnaire (DQOL)
Fear of Hypoglycemia 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.
Anxiety Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. The State-Trait Anxiety Inventory (STAI)
Coping Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Coping Inventory (COPE)
Distress 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.
Personality Pre treatment. Millon Clinical Multiaxial Inventory (MCMI-III)
Adherence Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Self-Care Inventory-revised (SCI-R)
Ketone Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Number of ketone test positive in the last year.
Blood glucose self-tests Pre treatment, post treatment (12 weeks), 3, 6 and 12 months. Number of blood glucose self-tests daily.
Complications of diabetes 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.
Another disease 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.
Trial Locations
- Locations (1)
University of Malaga
🇪🇸Málaga, Spain