Back to resultsTelematic Program for the Treatment of Depression in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus, Depression
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Treatment group (TG)
Control group (CG)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes, Depression, Telematic Program, Treatment, Web-based
Eligibility Criteria
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.
Sites / Locations
- University of MalagaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group (TG)
Control group (CG)
Arm Description
The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
The control group (CG) will be evaluated in the same phases as the TG.
Outcomes
Primary Outcome Measures
Depression
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5)
Depression symptoms
Beck Depression Inventory-Fast Screen (BDI-FS)
Secondary Outcome Measures
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.
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.
Quality of Life
Diabetes Quality of Life Questionnaire (DQOL)
Anxiety
The State-Trait Anxiety Inventory (STAI)
Coping
Coping Inventory (COPE)
Personality
Millon Clinical Multiaxial Inventory (MCMI-III)
Adherence
Self-Care Inventory-revised (SCI-R)
Glycemic control
Glycosylated hemoglobin test (HbA1c)
Hypoglycemia
Number of mild hypoglycemia weekly and severe hypoglycaemia in the last year.
Hyperglycemia
Number of hyperglycemia weekly.
Ketone
Number of ketone test positive in the last year.
Blood glucose self-tests
Number of blood glucose self-tests daily.
Complications of diabetes
Collect if there is any complication of diabetes in the patient's clinical history.
Another disease
Collect if there is any illness (other than diabetes) diagnosed by the doctor in the patient's clinical history.
Full Information
NCT ID
NCT03473704
First Posted
March 6, 2018
Last Updated
March 21, 2018
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborators
University of Malaga
1. Study Identification
Unique Protocol Identification Number
NCT03473704
Brief Title
Telematic Program for the Treatment of Depression in Type 1 Diabetes
Official Title
Assessment of the Effectiveness of a New Telematic Program for the Treatment of Depression in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborators
University of Malaga
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Depression
Keywords
Type 1 diabetes, Depression, Telematic Program, Treatment, Web-based
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group (TG)
Arm Type
Experimental
Arm Description
The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
Arm Title
Control group (CG)
Arm Type
Placebo Comparator
Arm Description
The control group (CG) will be evaluated in the same phases as the TG.
Intervention Type
Behavioral
Intervention Name(s)
Treatment group (TG)
Intervention Description
The Treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
Intervention Type
Behavioral
Intervention Name(s)
Control group (CG)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Depression
Description
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5)
Time Frame
Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Depression symptoms
Description
Beck Depression Inventory-Fast Screen (BDI-FS)
Time Frame
Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Secondary Outcome Measure Information:
Title
Fear of Hypoglycemia
Description
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.
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Distress
Description
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.
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Quality of Life
Description
Diabetes Quality of Life Questionnaire (DQOL)
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Anxiety
Description
The State-Trait Anxiety Inventory (STAI)
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Coping
Description
Coping Inventory (COPE)
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Personality
Description
Millon Clinical Multiaxial Inventory (MCMI-III)
Time Frame
Pre treatment.
Title
Adherence
Description
Self-Care Inventory-revised (SCI-R)
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Glycemic control
Description
Glycosylated hemoglobin test (HbA1c)
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Hypoglycemia
Description
Number of mild hypoglycemia weekly and severe hypoglycaemia in the last year.
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Hyperglycemia
Description
Number of hyperglycemia weekly.
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Ketone
Description
Number of ketone test positive in the last year.
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Blood glucose self-tests
Description
Number of blood glucose self-tests daily.
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Complications of diabetes
Description
Collect if there is any complication of diabetes in the patient's clinical history.
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Title
Another disease
Description
Collect if there is any illness (other than diabetes) diagnosed by the doctor in the patient's clinical history.
Time Frame
Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mónica Carreira, PhD
Phone
+34 952136697
Email
mcarreira@uma.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Teresa Anarte, PhD
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaga
City
Málaga
ZIP/Postal Code
29071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mónica Carreira, PhD
Phone
+34 952136697
Email
mcarreira@uma.es
First Name & Middle Initial & Last Name & Degree
Maria Teresa Anarte, PhD
Phone
+34 952132994
Email
anarte@uma.es
12. IPD Sharing Statement
Citations:
PubMed Identifier
18284670
Citation
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.
Results Reference
background
PubMed Identifier
20633742
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. Erratum In: Gen Hosp Psychiatry. 2010 Nov-Dec;32(6):645.
Results Reference
background
PubMed Identifier
36126050
Citation
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.
Results Reference
derived
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Telematic Program for the Treatment of Depression in Type 1 Diabetes
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