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Search / Trial NCT06239428

i-TREAT: An Internet-based Treatment for Eating Disorders

Launched by REGION OF SOUTHERN DENMARK · Jan 31, 2024

Trial Information

Current as of July 05, 2025

Not yet recruiting

Keywords

Eating Disorders Randomized Controlled Trial Digital Intervention E Health Adolescents Psychiatry

ClinConnect Summary

The i-TREAT clinical trial is studying a new online treatment program designed to help teenagers and adults in Denmark who struggle with certain eating disorders. This program, called i-TREAT, offers therapist-guided self-help through 12 online sessions that include interactive tasks, videos, and text support. The goal of the study is to see if this internet-based approach can more effectively reduce eating disorder symptoms and improve the quality of life compared to a control group that will only receive mindfulness materials while they wait for the treatment.

To participate in the trial, individuals must be between 15 and 17 years old or at least 18 years old, have a diagnosed eating disorder, and understand Danish. Participants will need consent from a parent if they are under 18. Those who join can expect to engage in online sessions over about 12 weeks, with feedback from their therapist along the way. It's important to note that some individuals will not be eligible to participate, such as those with very low body weight or severe mental health issues. The study is not yet recruiting participants, but the researchers plan to include 63 people in each group once they start.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age between 15 to 17 years, or age ≥ 18 years.
  • 2. Fulfilment of the diagnostic criteria for Other Specified Feeding or Eating Disorders according to DSM-V and ICD-11.
  • 3. Comprehension of the Danish language.
  • 4. Consent from at least one parent for participants between 15 to 17 years.
  • 5. Access to the Danish secure mail system E-boks.
  • Exclusion Criteria:
  • 1. Body Mass Index (BMI) ≤ 17,5.
  • 2. Lack of access to technological device (computer and tablet/iphone/android).
  • 3. Concurrent participation in other psychotherapeutic treatment.
  • 4. Concurrent diagnosis of severe depression, severe anxiety, or substance dependence disorder.
  • 5. Previously diagnosed with psychosis or Autism Spectrum Disorder.
  • 6. If on medication, medication must be stable for six months prior to, as well as during, the study participation (i.e., no changes in type of medication or dosage).

About Region Of Southern Denmark

The Region of Southern Denmark is a leading clinical trial sponsor dedicated to advancing medical research and improving patient care through innovative studies. Comprising a network of hospitals and healthcare facilities, the region fosters collaboration among healthcare professionals, researchers, and industry partners to facilitate the development of new therapies and treatments. By prioritizing ethical standards and patient safety, the Region of Southern Denmark aims to contribute significantly to the global medical research landscape while enhancing health outcomes for its diverse population.

Locations

Odense, Region Of Southern Denmark, Denmark

Patients applied

0 patients applied

Trial Officials

Marie P Folker, Cand.scient.

Study Chair

Centre for Digital Psychiatry

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported