i-TREAT: An Internet-based Treatment for Eating Disorders (NCT06239428) | Clinical Trial Compass
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i-TREAT: An Internet-based Treatment for Eating Disorders
Denmark126 participantsStarted 2024-09
Plain-language summary
This clinical study aims to compare the efficacy of an internet-based therapist-guided self-help intervention (named i-TREAT) in reducing eating disorder symptoms in Danish adolescents and adults with Other Specified Feeding or Eating Disorders (OSFED). The study is a randomized controlled trial, comparing the intervention group, receiving i-TREAT, with an active waitlist-control group, receiving online mindfulness material. The investigators hypothesize the intervention group to be superior to the waitlist-control group in terms of 1) reducing eating disorder symptoms and 2) increasing quality of life. The internet-based intervention (i-TREAT) consists of 12 online treatment sessions. It is mainly based on Cognitive Behavior Therapy while inspired by Acceptance and Commitment Therapy. Participants are instructed to complete session-related tasks and receive written feedback from their therapist throughout the treatment.
Furthermore, the intervention is also supported by text, illustrations, videos, and a chat function, allowing asynchronous text messaging with the therapist. The treatment courses are expected to run for up to 12 weeks. Participants completing the 12-week waitlist are subsequently offered the i-TREAT intervention. The investigators expect to include 63 participants in each group, who will be recruited through 1) self-referral on the project's website and 2) referral from mental health institutions and doctors.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age between 15 to 17 years, or age ≥ 18 years.
. Fulfilment of the diagnostic criteria for Other Specified Feeding or Eating Disorders according to DSM-V and ICD-11.
. Comprehension of the Danish language.
. Consent from at least one parent for participants between 15 to 17 years.
. Access to the Danish secure mail system E-boks.
Exclusion criteria
. Body Mass Index (BMI) ≤ 17,5.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eating Disorder Examination Questionnaire (EDE-Q)
Timeframe: Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months)
. Lack of access to technological device (computer and tablet/iphone/android).
. Concurrent participation in other psychotherapeutic treatment.
. Concurrent diagnosis of severe depression, severe anxiety, or substance dependence disorder.
. Previously diagnosed with psychosis or Autism Spectrum Disorder.
. 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).