Diabetes Mellitus, Type 1NCT06450730
Effectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D
A study testing Cognitive-Behavioral Therapy: face-to-face + app in people with Diabetes Mellitus, Type 1, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Type 1 diabetes (T1D) can lead to psychological adjustments that impact the acceptance and management of this health condition, as well as the overall quality of life of patients, especially among the young. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Cognitive-Behavioral Therapy: face-to-face + app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Girls and Boys with a diagnosis of T1D 6 - 18
- Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet
- Having the required digital skills to follow the mHealth intervention
- Not currently participating in another clinical trial involving a psychological intervention
Who cannot join
- Girls and Boys with a diagnosis of T1D >18 years
- Not Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet
- Currently participating in another clinical trial involving a psychological intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bárbara Luque, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Reina Sofía University Hospital
Córdoba, Córdoba, 14004
Bárbara Luque, PhD, +34 957218961, bluque@uco.es
Bárbara Luque, PhD
About this study
Official title: Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.
Type 1 diabetes (T1D) can lead to psychological adjustments that impact the acceptance and management of this health condition, as well as the overall quality of life of patients, especially among the young. Therefore, there is a need for psychological interventions aimed at enhancing the psychological well-being of children and adolescents with T1D. The goal of this non-randomized controlled trial is to evaluate whether a combined intervention comprising mHealth (using an app) and face-to-face psychological sessions based on Barlow's protocol and cognitive-behavioral therapy techniques (CBT) is effective in enhancing psychological well-being in children and adolescents with T1D. The main hypotheses are:
- H1: The primary results expected to be obtained are a significant increase in psychological well-being, which means a decreased diabetes distress (DDS) (H1a) an increased subjective well-being (PANAS) (H1b) and a better self-efficacy for managing their emotions (RESE) (H1c).
- H2: As secondary outcomes, it is also expected that the combined mHealth-CBT intervention would increase the level of positivity (P-Scale) (H2a), the self-esteem (RSES) (H2b) and the satisfaction with life (SWLS) (H2c).
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Cognitive-Behavioral Therapy: face-to-face + app
- Keywords
- Type 1 Diabetes, Cognitive-behavioral Therapy, mHealth interventions, Psychological well-being
- Medical subject headings
- Diabetes Mellitus, Type 1, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy: face-to-face + appBehavioural
This group will receive three 1-hour face-to-face CBT sessions (1,3,8). Participants will be involved in psychoeducation and practical activities related to psychological variables crucial for the adequate management of the disease (emotion regulation, self-efficacy, psychological flexibility, decision-making, etc.). These activities will include role-playing, discussions, and assignments to highlight the importance of emotions, thoughts, and healthy behaviors in managing diabetes and and their impact on the quality of life.
For the online sessions, an app will be developed to complement the face-to-face intervention. Participants will engage in 5-weeks of exercises with weekly activities related to the intervention content (2,5,6,7). The structure of the activities will mirror that of the face-to-face sessions and will include tasks, self-report instruments, reinforcement and activity monitoring. In addition, the app will incoportate multiple resources (texts, slides, videos).
| Study group | Role | What they receive |
|---|---|---|
| CBT face-to-face + app | Experimental | Combines face-to-face CBT sessions with online activities and resources trough a mobile app Receives: Behavioral: Cognitive-Behavioral Therapy: face-to-face + app |
| TAU Group | No intervention | TAU Group Patients of the control group continued their usual treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress
Diabetes Distress Scale (DDS; Polonsky et al., 2005) is a Likert-type scale of 17 items that measures the level of emotional distress related to diabetes in individuals living with this chronic condition and how it impacts their quality of life. Scores ranges from 1 "not a problem" to 5 "very serious problem".
Measured: Baseline, immediately after intervention and four months later (follow-up)
Regulatory Emotional Self-Efficacy
Regulatory Emotional Self-Efficacy scale (RESE; Caprara \& Gervino, 2001).It is designed to assess an individual's perceived self-efficacy in managing negative and expressing positive emotions. It is a five-point scale (1 = not capable at all; 5 = completely capable) to 12 items distributed across two factors: positive affect expression (4 items) and negative affect expression, further divided into handling dejection and distress (4 items), and handling anger and irritation (4 items).
Measured: Baseline, immediately after intervention and four months later (follow-up)
Positive Affect and Negative Affect
Positive Affect and Negative Affect Scale (PANAS; Watson et al., 1988) It is a Likert-type scale of 20-item (10 items for positive and 10 items for negative affect, that assesses the extent to which the participants experienced positive affect in the last 2 weeks. Rated on a 5-point scale from 1 "not at all" to 5 "very much". It has been validated in Spanish (López-Gomez, et al., 2015)
Measured: Baseline, immediately after intervention and four months later (follow-up)
Secondary outcomes (3)
Positivity
The Positivity Scale (P Scale; Zuffianò et al., 2019) evaluates the predisposition of people to estimate their life and their experiences from a positive perspective. It is an 8-item Likert-type scale, ranging from 1 "completely false" to 5 "completely true".
Measured: Baseline, immediately after intervention and four months later (follow-up)
Self-esteem
Rosenberg self-esteem scale (RSES; Rosenberg, 1965). The RSES is a10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be uni-dimensional. All items are answered using a 4-point Likert scale format ranging from 1 "strongly disagree" to 5 "strongly agree".
Measured: Baseline, immediately after intervention and four months later (follow-up)
Satisfaction with Life
Satisfaction with Life Scale (SWLS, Diener et al., 1985; Spanish adaptation by Atienza et al., 2000). The SWLS employs a 7-point Likert-style response scale with 5 items, ranging from 1 "completely disagree" to 5 "totally agree".
Measured: Baseline, immediately after intervention and four months later (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start11 Feb 2023
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Córdoba
- Responsible party
- Principal investigator, Rosario Castillo-Mayén, Maimónides Biomedical Research Institute of Córdoba
- Investigators
- Bárbara Luque, PhD, Principal investigator, Universidad de CórdobaCarmen Tabernero, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450730
- Sponsor's protocol ID
- PDI2019-107304RB-I00-BLS-T1D
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT06450730
- Acronym / sponsor ID
- PDI2019-107304RB-I00-BLS-T1D
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes, Cognitive-behavioral Therapy, mHealth interventions, Psychological well-being
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Universidad de Córdoba
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Jun 2024 (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.
Type 1 diabetes (T1D) can lead to psychological adjustments that impact the acceptance and management of this health condition, as well as the overall quality of life of patients, especially among the young. Therefore, there is a need for psychological interventions aimed at enhancing the psychological well-being of children and adolescents with T1D. The goal of this non-randomized controlled trial is to evaluate whether a combined intervention comprising mHealth (using an app) and face-to-face psychological sessions based on Barlow's protocol and cognitive-behavioral therapy techniques (CBT) is effective in enhancing psychological well-being in children and adolescents with T1D. The main hypotheses are:
- H1: The primary results expected to be obtained are a significant increase in psychological well-being, which means a decreased diabetes distress (DDS) (H1a) an increased subjective well-being (PANAS) (H1b) and a better self-efficacy for managing their emotions (RESE) (H1c).
- H2: As secondary outcomes, it is also expected that the combined mHealth-CBT intervention would increase the level of positivity (P-Scale) (H2a), the self-esteem (RSES) (H2b) and the satisfaction with life (SWLS) (H2c).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT face-to-face + app | Experimental | Behavioral: Cognitive-Behavioral Therapy: face-to-face + appCombines face-to-face CBT sessions with online activities and resources trough a mobile app |
| TAU Group | No intervention | –TAU Group Patients of the control group continued their usual treatment. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Girls and Boys with a diagnosis of T1D 6 - 18
- Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet
- Having the required digital skills to follow the mHealth intervention
- Not currently participating in another clinical trial involving a psychological intervention
Key exclusion criteria (3 listed)
- Girls and Boys with a diagnosis of T1D >18 years
- Not Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet
- Currently participating in another clinical trial involving a psychological intervention
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 |
|---|---|---|
| Cognitive-Behavioral Therapy: face-to-face + appThis group will receive three 1-hour face-to-face CBT sessions (1,3,8). Participants will be involved in psychoeducation and practical activities related to psychological variables crucial for the adequate management of the disease (emotion regulation, self-efficacy, psychological flexibility, decision-making, etc.). These activities will include role-playing, discussions, and assignments to highlight the importance of emotions, thoughts, and healthy behaviors in managing diabetes and and their impact on the quality of life. For the online sessions, an app will be developed to complement the face-to-face intervention. Participants will engage in 5-weeks of exercises with weekly activities related to the intervention content (2,5,6,7). The structure of the activities will mirror that of the face-to-face sessions and will include tasks, self-report instruments, reinforcement and activity monitoring. In addition, the app will incoportate multiple resources (texts, slides, videos). | Behavioural | CBT face-to-face + app |
Primary outcome
Diabetes Distress
Time frame: Baseline, immediately after intervention and four months later (follow-up)
Diabetes Distress Scale (DDS; Polonsky et al., 2005) is a Likert-type scale of 17 items that measures the level of emotional distress related to diabetes in individuals living with this chronic condition and how it impacts their quality of life. Scores ranges from 1 "not a problem" to 5 "very serious problem".
Regulatory Emotional Self-Efficacy
Time frame: Baseline, immediately after intervention and four months later (follow-up)
Regulatory Emotional Self-Efficacy scale (RESE; Caprara \& Gervino, 2001).It is designed to assess an individual's perceived self-efficacy in managing negative and expressing positive emotions. It is a five-point scale (1 = not capable at all; 5 = completely capable) to 12 items distributed across two factors: positive affect expression (4 items) and negative affect expression, further divided into handling dejection and distress (4 items), and handling anger and irritation (4 items).
Positive Affect and Negative Affect
Time frame: Baseline, immediately after intervention and four months later (follow-up)
Positive Affect and Negative Affect Scale (PANAS; Watson et al., 1988) It is a Likert-type scale of 20-item (10 items for positive and 10 items for negative affect, that assesses the extent to which the participants experienced positive affect in the last 2 weeks. Rated on a 5-point scale from 1 "not at all" to 5 "very much". It has been validated in Spanish (López-Gomez, et al., 2015)
3 secondary outcomes
Positivity
Time frame: Baseline, immediately after intervention and four months later (follow-up)
Self-esteem
Time frame: Baseline, immediately after intervention and four months later (follow-up)
Satisfaction with Life
Time frame: Baseline, immediately after intervention and four months later (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
Bárbara Luque, PhD contact
Bárbara Luque, PhD principal investigator
Universidad de Córdoba
Carmen Tabernero, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy: face-to-face + app in people with Diabetes Mellitus, Type 1, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosario Castillo-Mayén, PhD (+34 957218923, rcmayen@uco.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress (time frame: Baseline, immediately after intervention and four months later (follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.