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.

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 Overview

• Status: Recruiting
• Conditions: Suicide Risk; Eating Disorders
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT); Behavioral: Cognitive Behavioural Therapy (CBT)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain
      • Recruiting
      • Hospital Universitari Parc Tauli
      • Contact: Aleix Jorba; Phone Number: 695833020; Email: aleix.jc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)	Behavioral: Cognitive 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)
Active Comparator: Cognitive Behavioural Therapy (CBT)	Behavioral: Cognitive Behavioural Therapy (CBT); 8 structured group sessions based on Christopher Fairburn's program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.

Collaborators and Investigators

• Sponsor: Universitat Autonoma de Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Feeding and Eating Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 2024/3040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No