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Recruiting NCT07417826

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

No phase Interventional Eating Disorders Suicide Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioural Therapy (CBT), Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT).
Who it may be relevant to
Registry conditions: Eating Disorders, Suicide Risk. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

  • Behavioral Cognitive Behavioural Therapy (CBT)
    8 structured group sessions based on Christopher Fairburn's program.
  • 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)

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (2)
  • 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Hospital Universitari Parc Taulí — Sabadell

Identifiers

NCT: NCT07417826 · 2024/3040

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗