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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Stockholm and 1 other locations) |
| Status | Recruiting |
| Started | August 28, 2026 |
| Main results expected | December 31, 2034 |
| Study ends | December 31, 2034 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07878897 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
- Principal investigator: Martina Wolf-Arehult, PhD — Karolinska Institutet
- Study coordinator: Linnea Schalling, MSc
- Email: linnea.schalling@regionstockholm.se
- Phone: +46812344071
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
National Highly Specialized Care for Severe Self-Harm and Eating Disorders in Swedish Youth
This observational study tests how well NHV, a highly specialized care program, works for children and teens with severe self-harm or eating disorders by asking patients and their parents about their experiences and what changes they notice.
-
Adolescent Self-Injury Intervention Skills Training (ASIST) vs TAU
This study tests ASIST, a skills-based therapy for teens with non-suicidal self-injury, to see if it helps more than usual care.
-
FlexED: A digital program to help young women see thoughts and feelings about their body in a friendlier way
This trial tests a smartphone-based, gamified ACT-inspired program called FlexED to help young women and girls at risk for eating disorders see how they think and feel about their bodies, and to see if it can be feasibly spread to more people.
-
Impact of GLP-1 Receptor Agonist Therapy vs Structured Lifestyle on Weight and Health
This study tests whether starting a GLP-1 receptor agonist for weight loss works differently from a structured diet-and-exercise program in improving heart and metabolic health for adults with overweight or obesity.
-
FlexED: Full Threshold Body-Image Intervention for Young Women
A mobile, gamified ACT-based program is tested to see if it helps young women with eating disorders feel less distressed about their bodies and reduce symptoms.
-
Four CBT-E formats for Binge Eating Disorder in adults
This trial tests four different psychotherapy formats to see which best reduces binge-eating episodes in adults with Binge Eating Disorder.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.