Eating DisordersNCT07417826
Cognitive-Behavioral and Digital Therapy for Suicide Risk in Eating Disorders
A study testing Cognitive Behavioural Therapy (CBT) and Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) in people with Eating Disorders and Suicide Risk, run by Universitat Autonoma de Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to determine if adding a digital intervention to standard cognitive-behavioral therapy (CBT) is more effective in preventing suicide risk and reducing eating disorder symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Eating Disorders, Suicide Risk
- What is being tested?
- Cognitive Behavioural Therapy (CBT) and Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 22 Oct 2025to Oct 2028
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: Female.
- Age between 18 and 65 years old.
- Clinically stable and able to provide written informed consent.
- Subjects included in the "Suicide Risk Code" (Codi Risc Suïcidi - CRS) program due to recent suicidal ideation or suicide attempts.
- Patients with a diagnosis of an Eating Disorder (ED).
Who cannot join
- Presence of intellectual disability or cognitive impairment that prevents understanding the therapy or the study requirements.
- Diagnosis of Bipolar Disorder or any Psychotic Disorder.
- Current active substance abuse or dependence.
- Any medical condition that, in the investigator's opinion, makes participation unsafe or unfeasible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Parc Taulí
Sabadell, Barcelona
Aleix Jorba, 695833020, aleix.jc@gmail.com
About this study
Official title: Efficacy of Cognitive-behavioral Therapy (CBT) and Digital Therapy (DT) in the Prevention of Suicide Risk in Patients With Eating Disorders (ED): a Randomized Clinical Trial.
The purpose of this study is to determine if adding a digital intervention to standard cognitive-behavioral therapy (CBT) is more effective in preventing suicide risk and reducing eating disorder symptoms. Participants will be women between 18 and 65 years old who have recently experienced suicidal ideation or attempts. One group will receive standard group therapy, while the other will receive group therapy plus a mobile application and digital monitoring devices. The goal is to see if digital tools can improve clinical outcomes and safety for patients.
- Conditions
- Eating Disorders, Suicide Risk
- Being tested
- Cognitive Behavioural Therapy (CBT), Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy (CBT)Behavioural
8 structured group sessions based on Christopher Fairburn's program.
Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)Behavioural
DigitaI therapy: includes a mobile app with a digital safety plan (warning signs, coping strategies, contact persons, etc.) activated by real-time risk assessments (2-4 random questions daily)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) | Experimental | Not described Receives: Behavioral: Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) |
| Cognitive Behavioural Therapy (CBT) | Active comparator | Not described Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Eating Attitudes Test-26 (EAT-26) Score.
The EAT-26 is a self-report questionnaire used to assess eating disorder risk and symptoms. It consists of 26 items. Total scores range from 0 to 78, where higher scores indicate greater severity of eating disorder symptoms.
Measured: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Change from Baseline in Bulimic Investigatory Test Edinburgh (BITE) Score.
The BITE is used to identify individuals with binge-eating and compensatory behaviors. It consists of two subscales: Symptoms (0-30 points) and Severity (0-39 points). We will report the Total Score. Higher scores indicate higher levels of bulimic symptoms.
Measured: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score.
The C-SSRS Full Scale is a clinical tool used to assess the full spectrum of suicidal ideation and behavior. It consists of two main sections: (1) Suicidal Ideation (A severity scale ranging from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent) and (2) Suicidal Behavior (A scale that tracks the presence of actual, interrupted, or aborted attempts, and preparatory acts rated as Yes/No). For this outcome, we will report the Suicidal Ideation Severity Score. Higher scores indicate a greater severity of suicidal ideation.
Measured: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Secondary outcomes (2)
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score.
The PHQ-9 is a 9-item tool used to monitor the severity of depression. Scores range from 0 to 27. Higher scores indicate greater severity of depressive symptoms.
Measured: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score.
The GAD-7 is a 7-item scale used to measure the severity of generalized anxiety. Scores range from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.
Measured: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start22 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Autonoma de Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleix Jorba Chacón, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417826
- Sponsor's protocol ID
- 2024/3040
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cognitive-behavioral Therapy (CBT) and Digital Therapy (DT) in the Prevention of Suicide Risk in Patients With Eating Disorders (ED): a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07417826
- Acronym / sponsor ID
- 2024/3040
- Conditions
- Eating Disorders, Suicide Risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitat Autonoma de BarcelonaUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 18 Feb 2026 (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.
The purpose of this study is to determine if adding a digital intervention to standard cognitive-behavioral therapy (CBT) is more effective in preventing suicide risk and reducing eating disorder symptoms. Participants will be women between 18 and 65 years old who have recently experienced suicidal ideation or attempts. One group will receive standard group therapy, while the other will receive group therapy plus a mobile application and digital monitoring devices. The goal is to see if digital tools can improve clinical outcomes and safety for patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) | Experimental | Behavioral: Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) |
| Cognitive Behavioural Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioural Therapy (CBT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gender: Female.
- Age between 18 and 65 years old.
- Clinically stable and able to provide written informed consent.
- Subjects included in the "Suicide Risk Code" (Codi Risc Suïcidi - CRS) program due to recent suicidal ideation or suicide attempts.
- Patients with a diagnosis of an Eating Disorder (ED).
Key exclusion criteria (4 listed)
- Presence of intellectual disability or cognitive impairment that prevents understanding the therapy or the study requirements.
- Diagnosis of Bipolar Disorder or any Psychotic Disorder.
- Current active substance abuse or dependence.
- Any medical condition that, in the investigator's opinion, makes participation unsafe or unfeasible.
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 Behavioural Therapy (CBT)8 structured group sessions based on Christopher Fairburn's program. | Behavioural | Cognitive Behavioural Therapy (CBT) |
| Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)DigitaI therapy: includes a mobile app with a digital safety plan (warning signs, coping strategies, contact persons, etc.) activated by real-time risk assessments (2-4 random questions daily) | Behavioural | Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) |
Primary outcome
Change from Baseline in Eating Attitudes Test-26 (EAT-26) Score.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
The EAT-26 is a self-report questionnaire used to assess eating disorder risk and symptoms. It consists of 26 items. Total scores range from 0 to 78, where higher scores indicate greater severity of eating disorder symptoms.
Change from Baseline in Bulimic Investigatory Test Edinburgh (BITE) Score.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
The BITE is used to identify individuals with binge-eating and compensatory behaviors. It consists of two subscales: Symptoms (0-30 points) and Severity (0-39 points). We will report the Total Score. Higher scores indicate higher levels of bulimic symptoms.
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
The C-SSRS Full Scale is a clinical tool used to assess the full spectrum of suicidal ideation and behavior. It consists of two main sections: (1) Suicidal Ideation (A severity scale ranging from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent) and (2) Suicidal Behavior (A scale that tracks the presence of actual, interrupted, or aborted attempts, and preparatory acts rated as Yes/No). For this outcome, we will report the Suicidal Ideation Severity Score. Higher scores indicate a greater severity of suicidal ideation.
2 secondary outcomes
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month 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 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
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 Behavioural Therapy (CBT) and Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) in people with Eating Disorders and Suicide Risk, run by Universitat Autonoma de Barcelona 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 5 inclusion and 4 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 18 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Eating Attitudes Test-26 (EAT-26) Score. (time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month 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 18 Feb 2026.