Eating Disorders, Suicide Risk
Conditions
Brief 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.
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)
Sponsors
Universitat Autonoma de Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Eating Attitudes Test-26 (EAT-26) Score. | 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. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score. | Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up. | 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. |
| Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score. | Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up. | 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. |
Countries
Spain
Outcome results
None listed