Clinical trial Recruiting at 2 sites Observational Ages 18 and up

National Highly Specialized Care for adults with treatment-resistant self-harm and eating disorders (Substudy 1)

Official title: National Highly Specialized Care (NHV) for Adults With Treatment-Resistant Self-Harm and Eating Disorders: Assessment, Development, and Evaluation - Substudy 1: Investigation of Patients' and Their Significant Others' Experiences of National Highly Specialized Care (NHV), Feasibility and Preliminary Treatment Outcomes

Run by Karolinska Institutet · NCT07878897 · Data updated 2026-11-12

This study tests how people with severe, hard-to-turge self-harm or eating disorders in Sweden experience NHV care and whether the treatment helps with symptoms and daily functioning.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations2 sites (Stockholm and 1 other locations)
StatusRecruiting
StartedAugust 28, 2026
Main results expectedDecember 31, 2034
Study endsDecember 31, 2034
Registry record updatedOctober 21, 2026
Trial IDNCT07878897 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years and older referred to NHV for severe self-harm or eating disorders, and their identified significant others who can consent.

Probably not a fit

Patients who do not have a favorable response to NHV or whose condition does not improve may not experience substantial benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational substudy looks at adults receiving National Highly Specialized Care (NHV) for severe, treatment-resistant self-harm or eating disorders. It documents patient and significant other experiences, feasibility of NHV programs, and changes in symptoms, functioning, and quality of life during and after treatment. Interventions may include inpatient care or a mix of inpatient and intensive outpatient treatment, typically around 12 weeks, with adjustments based on clinical needs. Data are collected through self-report questionnaires, interviews, and medical records, with follow-up assessments potentially extending up to five years. The study is embedded in a broader program to develop and evaluate NHV in Sweden.

Why it matters

Potential benefit: If successful, the study could clarify how NHV models impact symptoms, functioning, and quality of life for adults with these conditions.

How similar studies have gone: Previous work in NHV and specialized care approaches suggests potential benefits, but this exact model is being evaluated in Sweden for this population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Patients:

* Aged 18 years or older.
* Referred to and accepted for National Highly Specialized Care (NHV) for severe self-harm or eating disorders.
* Able to provide informed consent to participate in the study.

Significant others:

* Aged 18 years or older.
* Nominated by a participating patient as a significant person in their life, such as a family member, partner, friend, or another important individual.
* Able to provide informed consent to participate in the study.

Exclusion Criteria:

Patients and significant others:

* Unable to provide informed consent.
* Insufficient ability to participate in study assessments, for example due to cognitive limitations or insufficient Swedish language proficiency.

Where it's running

  • Psykiatri Nordväst (PNV), Region Stockholm
    Stockholm, Sweden
    Recruiting
  • Stockholm Centre for Eating Disorders (SCÄ), Region Stockholm
    Stockholm, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.