Internet-based Cognitive-behavioral therapy (CBT) for depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study): A randomized controlled trial protocol

Mónica Carreira; María Soledad Ruiz de Adana; José Luis Pinzón; María Teresa Anarte-Ortiz

doi:10.1371/journal.pone.0274551

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.

Authors

Mónica Carreira¹, María Soledad Ruiz de Adana², José Luis Pinzón³, María Teresa Anarte-Ortiz¹

Affiliations

¹ Department of Personality, Assessment and Psychological Treatment, Biomedical Research Institute of Malaga (IBIMA), University of Malaga, Málaga, Spain.
² Clinical Management Unit of Endocrinology and Nutrition, Biomedical Research Institute of Malaga (IBIMA), Regional University Hospital, University of Malaga, Málaga, Spain.
³ Clinical Management Unit of Endocrinology and Nutrition, Biomedical Research Institute of Malaga (IBIMA), Virgen de la Victoria University Hospital, University of Malaga, Málaga, Spain.

Abstract

Background: Professionals need adequate tools to help patients with diabetes and depression. Although web programs integrating cognitive-behavioral therapy with diabetes education have shown good results, no similar approach has been performed as yet in Spain. The objective is to develop an Internet-based program for the treatment of mild-moderate depressive symptomatology in individuals with type 1 diabetes (WEB_TDDI1 study) based on Cognitive-behavioral therapy (CBT) and assess its results.

Methods: A 2-arm randomized controlled trial will be conducted. Adults with type 1 diabetes and mild-moderate depressive symptoms will be screened to participate in the study and randomly assigned to either the treatment group (TG) that will use a Web-based application for a specific 9-week intervention in depression and type 1 diabetes or the control group (CG) that will be on the waiting list during that time.

Results: Data on the primary variable (depressive symptoms) and secondary variables (treatment-related distress, anxiety, fear of hypoglycemia, quality of life, treatment adherence, coping strategies and glycemic control) will be collected from the TG at the beginning/baseline, at the end of treatment and at 3, 6 and 12 months after treatment. The CG will be assessed at the beginning and at the end of the TG intervention. On completion of the program by the TG, the treatment will then be carried out in the CG.

Conclusions: The new web application developed is expected to be effective for the treatment of mild-moderate depressive symptoms in adults with type 1 diabetes, reducing depressive symptoms and improving the rest of the analyzed variables.

Trial registration: Registry: NCT03473704 (March 21, 2018); ClinicalTrials.gov.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Cognitive Behavioral Therapy* / methods
Diabetes Mellitus, Type 1* / complications
Diabetes Mellitus, Type 1* / therapy
Humans
Hypoglycemia* / complications
Internet
Quality of Life
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT03473704

Grants and funding

The University of Málaga has contributed to the financing of this study through its Own Plan with two projects, providing material means for the design (Proyecto Puente of the University of Málaga: Development of a telematic application for the treatment of depression in type 1 diabetes.) and development of the same (Proyecto Puente B.5 of the University of Málaga: Evaluation of the effectiveness of a new telematic program for the treatment of depression in patients with type 1 diabetes.) as well as personnel (postdoctoral contract). This study has also been financed within the framework of the FEDER Andalusian Program 2014-2020(Reference: UMA20-FEDERJA008).