Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Sep 20;17(9):e0274551.
doi: 10.1371/journal.pone.0274551. eCollection 2022.

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  1 , María Soledad Ruiz de Adana  2 , José Luis Pinzón  3 , María Teresa Anarte-Ortiz  1
Affiliations

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 et al. PLoS One. .

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.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. SPIRIT schedule of enrolment, intervention and assessments.
Note: -t1, Eligibility screen, Informed consent; t1, baseline assessment; t2, post 8-week intervention; t3, 3-month follow-up; t4, 6-month follow-up; t5, 12-month follow-up; t6, participants complete treatment and follow-up in both the TG and the CG.
See this image and copyright information in PMC

References

    1. Roy T, Lloyd CE. Epidemiology of depression and diabetes: A systematic review. J Affect Disord. 2012; 142S1:S8–S21. doi: 10.1016/S0165-0327(12)70004-6 - DOI - PubMed
    1. Blay SL, Fillenbaum GG, Marinho V, Andreoli SB, Gastal FL. Increased health burden associated with comorbid depression in older Brazilians with diabetes. J Affect Disord. 2011;134:77–84. doi: 10.1016/j.jad.2011.05.012 - DOI - PMC - PubMed
    1. de Groot M, Anderson R, Freedland KE, Clouse RE, Lustman PJ. Association of depression and diabetes complications: a meta-analysis. Psychosom Med. 2001;63:619–630. doi: 10.1097/00006842-200107000-00015 - DOI - PubMed
    1. Ciechanowski PS, Katon WJ, Russo JE. Depression and diabetes: impact of depressive symptoms on adherence, function, and costs. Arch Intern Med. 2000;160:3278–3285. doi: 10.1001/archinte.160.21.3278 - DOI - PubMed
    1. Ciechanowski PS, Katon WJ, Russo JE, Hirsch IB. The relationship of depressive symptoms to symptom reporting, self care and glucose control in diabetes. Diabetes Care. 2003;25:731–736. doi: 10.1016/s0163-8343(03)00055-0 - DOI - PubMed

Publication types

Associated data