Telematic Program for the Treatment of Depression in Type 1 Diabetes

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Treatment group (TG); Behavioral: Control group (CG)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain, 29071
    • Recruiting
    • University of Malaga
    • Contact: Mónica Carreira, PhD; Phone Number: +34 952136697; Email: mcarreira@uma.es
    • Contact: Maria Teresa Anarte, PhD; Phone Number: +34 952132994; Email: anarte@uma.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group (TG); The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.	Behavioral: Treatment group (TG); The Treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
Placebo Comparator: Control group (CG); The control group (CG) will be evaluated in the same phases as the TG.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Depression symptoms	Beck Depression Inventory-Fast Screen (BDI-FS)	Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Collaborators: University of Malaga
• Investigators: Principal Investigator: María Teresa Anarte, PhD, University of Malaga

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Gen Hosp Psychiatry. 2010 Nov-Dec;32(6):645.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2017
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Treatment; Type 1 diabetes; Web-based; Telematic Program
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Mood Disorders; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Depression; Depressive Disorder; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: WEB_TDDI1 STUDY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No