Clinical trial NCT03473704: Telematic Program for the Treatment of Depression in Type 1 Diabetes
Official title: Assessment of the Effectiveness of a New Telematic Program for the Treatment of Depression in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Depression
Keywords: Type 1 diabetes
Depression
Telematic Program
Treatment
Web-based
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
Collaborators: name: University of Malaga
First posted: 2018-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Depression
timeFrame: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Depression symptoms
timeFrame: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary outcomes:
measure: Fear of Hypoglycemia
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Distress
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Quality of Life
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Anxiety
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Coping
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Personality
timeFrame: Pre treatment.
measure: Adherence
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Glycemic control
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Hypoglycemia
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Hyperglycemia
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Ketone
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Blood glucose self-tests
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Complications of diabetes
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
measure: Another disease
timeFrame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: University of Malaga
Study officials:
affiliation: University of Malaga
name: María Teresa Anarte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Bastelaar KM, Pouwer F, Cuijpers P, Twisk JW, Snoek FJ. Web-based cognitive behavioural therapy (W-CBT) for diabetes patients with co-morbid depression: design of a randomised controlled trial. BMC Psychiatry. 2008 Feb 19;8:9. doi: 10.1186/1471-244X-8-9.
citation: van der Feltz-Cornelis CM, Nuyen J, Stoop C, Chan J, Jacobson AM, Katon W, Snoek F, Sartorius N. Effect of interventions for major depressive disorder and significant depressive symptoms in patients with diabetes mellitus: a systematic review and meta-analysis. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):380-95. doi: 10.1016/j.genhosppsych.2010.03.011. Epub 2010 May 15.
citation: Carreira M, Ruiz de Adana MS, Pinzon JL, Anarte-Ortiz MT. Internet-based Cognitive-behavioral therapy (CBT) for depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study): A randomized controlled trial protocol. PLoS One. 2022 Sep 20;17(9):e0274551. doi: 10.1371/journal.pone.0274551. eCollection 2022.