Type 1 Diabetes MellitusNCT03473704

Telematic Program for the Treatment of Depression in Type 1 Diabetes

A study testing Treatment group (TG) in people with Type 1 Diabetes Mellitus and Depression, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Type 1 Diabetes Mellitus, Depression
What is being tested?: Treatment group (TG)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteSpain
Study dates: 19 Jan 2017to 1 Oct 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 12Show fewer

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Mónica Carreira, PhD contact

+34 952136697

mcarreira@uma.es

Spain1 site, 1 recruiting

University of Malaga
Málaga, 29071
Mónica Carreira, PhD, +34 952136697, mcarreira@uma.es
Maria Teresa Anarte, PhD, +34 952132994, anarte@uma.es
Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Type 1 Diabetes Mellitus, Depression
Being tested: Treatment group (TG), Control group (CG)
Keywords: Type 1 diabetes, Depression, Telematic Program, Treatment, Web-based
Medical subject headings: Diabetes Mellitus, Type 1, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03473704
Study group	Role	What they receive
Treatment group (TG)	Experimental	The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions. Receives: Behavioral: Treatment group (TG)
Control group (CG)	Placebo comparator	The control group (CG) will be evaluated in the same phases as the TG. Receives: Behavioral: Control group (CG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5)
Measured: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Depression symptoms
Beck Depression Inventory-Fast Screen (BDI-FS)
Measured: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

Secondary outcomes (14)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 20171 Oct 2020

First posted22 Mar 2018
Study start19 Jan 2017
Primary completion1 Oct 2020 (estimated)
Study completion1 Oct 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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: Single blind
Who is masked: Care provider
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03473704
Sponsor's protocol ID: WEB_TDDI1 STUDY
Status last verified: Feb 2018
First submitted: 6 Mar 2018
Last updated: 22 Mar 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 18284670
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.
PubMed 20633742
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.
PubMed 38028977
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.
PubMed 36126050

Want to know more?

Mónica Carreira, PhD

+34 952136697

mcarreira@uma.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Effectiveness of a New Telematic Program for the Treatment of Depression in Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT03473704
Acronym / sponsor ID: WEB_TDDI1 STUDY
Conditions: Type 1 Diabetes Mellitus, Depression
Keywords: Type 1 diabetes, Depression, Telematic Program, Treatment, Web-based
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
Collaborators: University of Malaga
Study start: 19 Jan 2017 (actual)
Primary completion: 1 Oct 2020 (estimated)
Study completion: 1 Oct 2020 (estimated)
First posted: 22 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2
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.

Arm	Type	Receives
Treatment group (TG)	Experimental	Behavioral: Treatment group (TG)The treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
Control group (CG)	Placebo comparator	Behavioral: Control group (CG)The control group (CG) will be evaluated in the same phases as the TG.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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;

Key exclusion criteria (8 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment group (TG)The Treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.	Behavioural	Treatment group (TG)
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).	Behavioural	Control group (CG)

Primary outcome

Depression
Time frame: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5)
Depression symptoms
Time frame: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Beck Depression Inventory-Fast Screen (BDI-FS)

14 secondary outcomes

Fear of Hypoglycemia
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Distress
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Quality of Life
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Anxiety
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Coping
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Personality
Time frame: Pre treatment.
Adherence
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Glycemic control
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Hypoglycemia
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Hyperglycemia
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Ketone
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Blood glucose self-tests
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Complications of diabetes
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.
Another disease
Time frame: Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
Background: PubMed 18284670van 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.
Background: PubMed 20633742van 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.
Derived from this study: PubMed 38028977Carreira 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.
Derived from this study: PubMed 36126050Carreira 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.

Related trials for Type 1 Diabetes Mellitus

Recruiting
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
Type 1 Diabetes
RecruitingPhase 3
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
CKM For Safe Use of SGLT2i in Type 1 Diabetes
Type 1 Diabetes (T1D)
Active, not recruitingPhase 1
Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen
Diabetes Mellitus
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mónica Carreira, PhD contact

+34 952136697

mcarreira@uma.es

María Teresa Anarte, PhD principal investigator

University of Malaga

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mónica Carreira, PhD (+34 952136697, mcarreira@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression (time frame: Change between Pre treatment, post treatment (12 weeks), 3, 6 and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473704, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.