NCT07417826

Cognitive-Behavioral and Digital Therapy for Suicide Risk in Eating Disorders

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Universitat Autonoma de Barcelona · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioural Therapy (CBT)	8 structured group sessions based on Christopher Fairburn's program.
BEHAVIORAL	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)

Timeline

• Start date: 2025-10-22
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Spain