Actively Recruiting
Efficacy of Cognitive-behavioral Therapy and Digital Therapy in Preventing Suicide Risk in Patients With Eating Disorders
Led by Universitat Autonoma de Barcelona · Updated on 2026-02-18
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding a digital intervention to standard cognitive-behavioral therapy (CBT) can better prevent suicide risk and reduce symptoms of eating disorders in women aged 18 to 65 years who have recently experienced suicidal thoughts or attempts. This randomized clinical trial aims to compare outcomes between a group receiving only standard group therapy and another group receiving group therapy combined with digital tools. The study is sponsored by Universitat Autonoma de Barcelona and focuses on improving clinical outcomes and safety for patients with eating disorders and suicide risk. Participants will be assigned to one of two groups: one receiving eight structured group CBT sessions based on Christopher Fairburn's program, and the other receiving the same CBT sessions plus digital therapy. The digital therapy includes a mobile application featuring a digital safety plan with warning signs, coping strategies, and emergency contacts, which is activated by real-time risk assessments through 2 to 4 random daily questions. The treatment period lasts eight weeks. During the study, participants will be assessed at baseline, at the end of treatment (week 8), and again at six and twelve months to measure changes in eating disorder symptoms, suicide risk, depression, and anxiety using standardized scales such as the Eating Attitudes Test-26 (EAT-26), Bulimic Investigatory Test Edinburgh (BITE), Columbia Suicide Severity Rating Scale (C-SSRS), Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder-7 (GAD-7). These assessments help monitor clinical progress and safety throughout the trial period.
CONDITIONS
Brief Title
Cognitive-Behavioral and Digital Therapy for Suicide Risk in Eating Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female gender
- Age between 18 and 65 years old
- Clinically stable and able to provide written informed consent
- Recent suicidal ideation or suicide attempts included in the "Suicide Risk Code" program
- Diagnosis of an eating disorder
You will not qualify if you...
- Intellectual disability or cognitive impairment preventing understanding of therapy or study requirements
- Diagnosis of bipolar disorder or any psychotic disorder
- Current active substance abuse or dependence
- Any medical condition making participation unsafe or unfeasible according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive 8 structured group sessions of cognitive-behavioral therapy, with some also using a mobile app for digital therapy including safety plans and real-time risk assessments.
Weekly visits for 8 weeks
Duration - Up to 12 months
Participants are monitored for changes in eating attitudes, suicide risk, depression, and anxiety up to 12 months after treatment.
Visits at 6-month and 12-month follow-up
Trial Site Locations
Total: 1 location
1
Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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