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NCT Number: NCT07417826

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

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.

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Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Suicide Risk

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Parc Taulí

Sabadell, Barcelona, Spain

Location status: Recruiting

Location contact

Aleix Jorba

CONTACT

[email protected]

695833020

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioural Therapy (CBT)

Behavioral

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

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)

Primary outcomes

  1. Change from Baseline in Eating Attitudes Test-26 (EAT-26) Score.

    Time frame: 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.

  2. Change from Baseline in Bulimic Investigatory Test Edinburgh (BITE) Score.

    Time frame: 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.

  3. Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score.

    Time frame: 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 outcomes

  1. Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score.

    Time frame: 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.

  2. Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitat Autonoma de Barcelona

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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