RecruitingNot ApplicableNCT07417826

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.

Sponsor

Universitat Autonoma de Barcelona

Enrollment

150 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Eating Disorders Suicide Risk

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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).

Exclusion Criteria4

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.

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Interventions

BEHAVIORALCognitive Behavioural Therapy (CBT)

8 structured group sessions based on Christopher Fairburn's program.

BEHAVIORALCognitive 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)