Group cognitive-behavioral therapy with added mobile app and digital monitoring for women with eating disorders and recent suicide risk
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.
This program will test whether adding a mobile app and digital monitoring to group CBT helps women with eating disorders who recently had suicidal thoughts or attempts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Universitat Autonoma de Barcelona Academic / other |
| Locations | 1 site (Sabadell, Barcelona) |
| Trial ID | NCT07417826 on ClinicalTrials.gov |
What this trial studies
Women aged 18–65 who are enrolled in the Suicide Risk Code program and have an eating disorder will be assigned to one of two approaches: standard group cognitive-behavioral therapy (CBT) or group CBT plus a mobile application and digital monitoring devices. The digital arm includes a smartphone app and wearable or remote monitoring to track symptoms and safety signals between therapy sessions. Clinical outcomes will focus on suicidal ideation/behaviors and eating-disorder symptoms over the study follow-up period. The trial is conducted at Hospital Universitari Parc Taulí in Sabadell, Barcelona, with participants required to be clinically stable and able to consent.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–65 with a diagnosed eating disorder who have recently experienced suicidal ideation or attempts and are enrolled in the Suicide Risk Code program, are clinically stable, and can give informed consent.
Not a fit: Patients with bipolar or psychotic disorders, active substance dependence, intellectual disability or cognitive impairment, unstable medical conditions, or those unable to attend the Barcelona site are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, combining digital tools with CBT could reduce suicidal thoughts and improve eating disorder symptoms by enabling ongoing monitoring and more timely support.
How similar studies have performed: Prior research shows CBT and some digital interventions can help eating-disorder symptoms and reduce suicidal ideation in certain groups, but combining group CBT with continuous digital monitoring for suicide risk in this specific population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Sabadell, Barcelona
- Hospital Universitari Parc Taulí — Sabadell, Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.