Cognitive-Behavioral and Digital Therapy for Suicide Risk in Eating Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversitat Autonoma de Barcelona
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioural Therapy (CBT)
Behavioral8 structured group sessions based on Christopher Fairburn's program.
Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)
BehavioralDigitaI 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)
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)Experimental treatment 1 intervention
Group B: Cognitive Behavioural Therapy (CBT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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.2
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.3
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.Secondary outcomes
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov