Cognitive-Behavioral and Digital Therapy for Suicide Risk in Eating Disorders

NCT07417826 | Recruiting DMC

• 1 other identifier: 2024/3040
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Suicide Risk

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (2)

Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)

EXPERIMENTAL

Behavioral: Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)

Cognitive Behavioural Therapy (CBT)

ACTIVE COMPARATOR

Behavioral: Cognitive Behavioural Therapy (CBT)

Interventions

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

8 structured group sessions based on Christopher Fairburn's program.

Cognitive Behavioural Therapy (CBT)

Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) BEHAVIORAL

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)

Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Autonoma de Barcelona: lead

Study Sites (1)

Hospital Universitari Parc Taulí

Sabadell, Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical psychologist

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 18, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)