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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
8 structured group sessions based on Christopher Fairburn's program.
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)
Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain
RECRUITINGChange from Baseline in Eating Attitudes Test-26 (EAT-26) Score.
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.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Change from Baseline in Bulimic Investigatory Test Edinburgh (BITE) Score.
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.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score.
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.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score.
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.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score.
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.
Time frame: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
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