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

Sponsor
Universitat Autonoma de Barcelona
Study ID
NCT07417826
Status
Recruiting
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Conditions

  • Eating Disorders
  • Suicide Risk

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

First listed
Feb 18, 2026
Start date
Oct 22, 2025
Status verified
Feb 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)
  • Active Comparator: Cognitive Behavioural Therapy (CBT)

Primary Outcome Measure

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. ]

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