Telematic Program for the Treatment of Depression in Type 1 Diabetes

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03473704
• Other study ID #: WEB_TDDI1 STUDY
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2018
• Last updated: March 21, 2018
• Start date: January 19, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2018
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: Mónica Carreira, PhD
• Phone: +34 952136697
• Email: mcarreira[@]uma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Spain	University of Malaga	Málaga

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	University of Malaga

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. Review. Erratum in: Gen Hosp Psychiatry. 2010 Nov-Dec;32(6):645. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Depression symptoms	Beck Depression Inventory-Fast Screen (BDI-FS)	Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	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.
Secondary	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.
Secondary	Quality of Life	Diabetes Quality of Life Questionnaire (DQOL)	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	Anxiety	The State-Trait Anxiety Inventory (STAI)	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	Coping	Coping Inventory (COPE)	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	Personality	Millon Clinical Multiaxial Inventory (MCMI-III)	Pre treatment.
Secondary	Adherence	Self-Care Inventory-revised (SCI-R)	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	Glycemic control	Glycosylated hemoglobin test (HbA1c)	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	Hypoglycemia	Number of mild hypoglycemia weekly and severe hypoglycaemia in the last year.	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	Hyperglycemia	Number of hyperglycemia weekly.	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	Ketone	Number of ketone test positive in the last year.	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	Blood glucose self-tests	Number of blood glucose self-tests daily.	Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary	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.
Secondary	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.