Telematic Program for the Treatment of Depression in Type 1 Diabetes

NCT03473704 | Unknown

• 1 other identifier: WEB_TDDI1 STUDY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; Depression

Keywords

Type 1 diabetes; Depression; Telematic Program; Treatment; Web-based

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Fear of Hypoglycemia

  Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

• Distress

  Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

• Quality of Life

  Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

• Anxiety

  Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

• Coping

  Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

Study Arms (2)

Treatment group (TG)

EXPERIMENTAL

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

Behavioral: Treatment group (TG)

Control group (CG)

PLACEBO COMPARATOR

The control group (CG) will be evaluated in the same phases as the TG.

Behavioral: Control group (CG)

Interventions

Treatment group (TG) BEHAVIORAL

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

Treatment group (TG)

Control group (CG) BEHAVIORAL

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).

Control group (CG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• University of Malaga: collaborator

Study Sites (1)

University of Malaga

Málaga, 29071, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 18284670 BACKGROUND

• 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.

  PMID: 20633742 BACKGROUND

• Carreira M, Ruiz de Adana MS, Pinzon JL, Anarte-Ortiz MT. Internet-based cognitive-behavioral therapy is effective in reducing depressive symptomatology in type 1 diabetes: results of a randomized controlled trial. Front Clin Diabetes Healthc. 2023 Nov 7;4:1209236. doi: 10.3389/fcdhc.2023.1209236. eCollection 2023.

  PMID: 38028977 DERIVED

• 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.

  PMID: 36126050 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Depression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• María Teresa Anarte, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mónica Carreira, PhD

CONTACT

+34 952136697; mcarreira@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 6, 2018
• First Posted: March 22, 2018
• Study Start: January 19, 2017
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 22, 2018

Record last verified: 2018-02

Locations

ES (1)