An observational study in Self-harm Behavior, Eating Disorders and Non-suicidal Self-injury (NSSI), sponsored by Karolinska Institutet. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Karolinska Institutet · Observational
This study aims to evaluate National Highly Specialized Care (NHV) for adults with severe and treatment-resistant self-harm or eating disorders in Sweden. The study examines patients' and their significant others' experiences of care, the feasibility of the treatment programs, and changes in patients' symptoms and functioning during and after treatment.
Participants receive specialized inpatient care or a combination of inpatient and intensive outpatient treatment, based on their individual clinical needs. Treatment typically lasts approximately 12 weeks but may vary depending on the patient's circumstances. Additional interventions may be provided to address co-occurring psychiatric conditions.
Information is collected through self-report questionnaires, qualitative interviews, and clinical records. Patients and their significant others are invited to complete assessments during treatment and at follow-up, including up to five years after treatment. The findings are expected to contribute to improving specialized care for people with severe self-harm and eating disorders.
This prospective observational study is part of a broader research project aimed at assessing, developing, and evaluating National Highly Specialized Care (NHV) for adults with severe and treatment-resistant self-harm and eating disorders in Sweden.
Study Design and Treatment
The study includes adults receiving NHV for severe self-harm or eating disorders, as well as their significant others. Treatment is determined by clinical needs and is not assigned according to the research protocol.
NHV provides highly specialized treatment, typically involving approximately 12 weeks of inpatient care or a combination of inpatient and intensive outpatient treatment. Treatment approaches include dialectical behavior therapy (DBT) for self-harm and cognitive behavioral therapy (CBT) or Specialist Supportive Clinical Management (SSCM) for eating disorders. Additional interventions may be provided to address co-occurring psychiatric conditions. The treatment programs also include preparation and follow-up phases. The duration and content of treatment may be adapted to individual needs.
Study Objectives
The study aims to investigate patients' and their significant others' experiences of NHV, changes in psychiatric symptoms, functioning, quality of life, and psychological skills, as well as the feasibility and acceptability of the treatment programs. It also aims to examine associations between clinical and psychological variables and treatment outcomes.
Data Collection
Patients and their significant others are invited to complete questionnaires at four time points: treatment start, treatment completion, 12 months after completion, and five years after completion.
Patients complete measures assessing psychiatric symptoms, functioning, quality of life, psychological skills, and treatment-related experiences. Brief weekly assessments of core symptoms are also conducted during treatment. For patients with eating disorders, relevant physical parameters are collected.
Significant others complete questionnaires concerning the patient's symptoms, well-being, and psychological skills, as well as their own emotion regulation, validation, and experiences of treatment.
Qualitative interviews with patients and their significant others are conducted towards the end of treatment and five years after treatment completion. Interviews explore experiences of NHV, perceived benefits, challenges, and suggestions for improvement. Interviews are conducted by psychologists who are not involved in the participants' treatment and are transcribed and pseudonymized before being analyzed using thematic analysis.
Additional clinical information is obtained from medical records, including diagnoses, treatment characteristics and treatment history, treatment adherence, number of inpatient care days, involuntary psychiatric care and the number of coercive measures, as well as sources of income and financial support, including sick leave during the preceding 12 months.
Evaluation
Clinical outcomes are examined through changes in symptoms, functioning, quality of life, and psychological skills over time. Associations between clinical and psychological variables and treatment outcomes are also investigated.
Feasibility and acceptability are evaluated through recruitment, treatment completion and adherence, treatment credibility and expectations, and satisfaction.
Qualitative interview data are analyzed using thematic analysis to identify recurring themes and patterns in patients' and significant others' experiences of NHV. Qualitative and quantitative findings will be integrated to provide a comprehensive understanding of treatment experiences, outcomes, and factors relevant to the further development of highly specialized care for adults with severe self-harm and eating disorders.
753 studies on the registry are indexed under Feeding and Eating Disorders; 160 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 185 observational studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.
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The study population consists of approximately 100 adult patients receiving National Highly Specialized Care (NHV) for severe self-harm (n = 50) or eating disorders (n = 50), and approximately 150 significant others nominated by participating patients. Patients are recruited from specialized psychiatric services providing NHV in Sweden. Significant others may include family members, partners, friends, or other individuals identified by the patient as important in their life. Only individuals nominated by a participating patient are invited to participate. Patients and significant others are followed during treatment and at subsequent follow-up assessments.
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Patients:
Significant others:
Exclusion Criteria:
Patients and significant others:
This cohort includes 100 adult patients receiving National Highly Specialized Care (NHV) for severe and treatment-resistant self-harm (n=50) or eating disorders (n=50), as well as 150 significant others. Patients receive individualized specialized treatment based on their clinical needs. Patients and significant others participate in assessments of treatment experiences, feasibility, and clinical outcomes during treatment and at follow-up.
Behavioral: National Highly Specialized Care (NHV)
National Highly Specialized Care (NHV) provides individualized treatment for adults with severe and treatment-resistant self-harm or eating disorders. Treatment typically involves approximately 12 weeks of inpatient care or a combination of inpatient and intensive outpatient treatment. Treatment approaches include dialectical behavior therapy (DBT) for self-harm and cognitive behavioral therapy (CBT) or Specialist Supportive Clinical Management (SSCM) for eating disorders. Additional interventions may be provided to address co-occurring psychiatric conditions. Treatment includes preparation and follow-up phases, and its duration and content are adapted to individual clinical needs. Treatment is determined independently of participation in the observational study.
Treatment Completion Rate
Proportion of patients who complete the planned National Highly Specialized Care (NHV) treatment program, based on information from the treating clinician. Higher percentages indicate higher treatment completion rates.
Time frame: From treatment initiation to treatment completion (approximately 12 weeks, depending on individual treatment duration).
Treatment Attendance
Treatment attendance will be evaluated in relation to the individual's planned treatment activities, based on information provided by the treating clinician. Higher attendance indicates greater participation in planned treatment activities.
Time frame: Throughout the NHV treatment period (approximately 12 weeks, depending on individual treatment duration).
Patients' and significant others' experiences of National Highly Specialized Care
Qualitative semi-structured interviews exploring patients' and relatives' experiences of NHV, including perceived treatment benefits, negative effects, challenges, and areas for improvement. Interview data will be analyzed using reflexive thematic analysis.
Time frame: At treatment completion (approximately 12 weeks) and five years after treatment completion.
Treatment Credibility and Expectancy (Credibility/Expectancy Questionnaire; CEQ)
Patients' and significant others' perceptions of treatment credibility and expectations regarding treatment outcomes are assessed using the 6-item Credibility/Expectancy Questionnaire (CEQ). The questionnaire consists of two subscales: treatment credibility (3 items) and treatment expectancy (3 items). Scores for each subscale range from 3 to 27, with higher scores indicating greater perceived treatment credibility and higher expectations of treatment-related improvement, respectively.
Time frame: During the initial phase of NHV treatment (within the first third of treatment, approximately weeks 1-4).
Treatment Satisfaction (Treatment Satisfaction Scale, Version 2; TSS-2)
Treatment satisfaction is assessed using the Treatment Satisfaction Scale, Version 2 (TSS-2) (with patients and significant others). The questionnaire consists of six items assessing satisfaction with the treatment received. Five items are scored from 0 to 3 and one item from 0 to 4, yielding a total score ranging from 0 to 19. Higher scores indicate greater treatment satisfaction.
Time frame: At NHV treatment completion (approximately 12 weeks).
Treatment Acceptability (Visual Analogue Scale; VAS)
Patients' and significant others' perceived acceptability of National Highly Specialized Care (NHV) is assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores indicating greater treatment acceptability. The measure is administered to patients receiving NHV for severe self-harm or eating disorders and their significant others.
Time frame: During the initial phase of NHV treatment (within the first third of treatment, approximately weeks 1-4).
Change in Self-Harm Behaviors (Deliberate Self-Harm Inventory; DSHI-9), with two additional items, 3 months
Self-harm behaviors are assessed using a modified 9-item version of the Deliberate Self-Harm Inventory (DSHI-9), in which two items from the original questionnaire (items 1 and 2) have been combined into one to reduce respondent burden. The questionnaire is administered to patients receiving NHV for severe self-harm or eating disorders. The frequency of self-harm behaviors during the preceding three months is assessed, and changes are evaluated over time, with higher scores indicating more frequent self-harm. Two additional items assessing deliberate foreign body ingestion (DFBI) and intentional overdose are evaluated separately.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Eating Disorder Psychopathology (Eating Disorder Examination Questionnaire; EDE-Q)
Eating disorder psychopathology is assessed using the Eating Disorder Examination Questionnaire (EDE-Q) in patients receiving NHV for eating disorders. The EDE-Q assesses eating disorder attitudes and behaviors during the preceding 28 days. The global score ranges from 0 to 6, with higher scores indicating more severe eating disorder psychopathology.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Body Mass Index (BMI)
Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), is assessed in patients receiving NHV for eating disorders. Changes in BMI are evaluated over time using clinical measurements and medical records.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Depressive Symptoms (Montgomery-Åsberg Depression Rating Scale, Self-Report; MADRS-S)
Depressive symptoms are assessed using the 9-item self-report version of the Montgomery-Åsberg Depression Rating Scale (MADRS-S) in patients receiving NHV for severe self-harm or eating disorders. Each item is scored from 0 to 6, yielding a total score ranging from 0 to 54, with higher scores indicating greater severity of depressive symptoms.
Time frame: At treatment start, treatment completion (approximately 12 weeks), 12 months and five years after treatment completion.
Change in Eating Disorder-Related Functional Impairment (Clinical Impairment Assessment; CIA)
Eating disorder-related functional impairment is assessed using the 16-item Clinical Impairment Assessment (CIA) in patients receiving NHV for eating disorders. Total scores range from 0 to 48, with higher scores indicating greater impairment associated with eating disorder symptoms.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in General Functioning (World Health Organization Disability Assessment Schedule 2.0; WHODAS-12)
General functioning and disability are assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS-12) in both patient groups. Using simple summed scoring, total scores range from 12 to 60, with higher scores indicating greater functional impairment.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Quality of Life (Brunnsviken Brief Quality of Life Scale; BBQ)
Subjective quality of life is assessed using the 12-item Brunnsviken Brief Quality of Life Scale (BBQ) in patients receiving NHV for severe self-harm. The scale assesses satisfaction with important life domains, weighted by their perceived importance. Total scores range from 0 to 96, with higher scores indicating better perceived quality of life.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Perceived Social Support (Multidimensional Scale of Perceived Social Support; MSPSS)
Perceived social support is assessed using the 12-item Multidimensional Scale of Perceived Social Support (MSPSS) in both patient groups. The questionnaire assesses perceived support from family, friends, and significant others. Mean scores range from 1 to 7, with higher scores indicating greater perceived social support.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Emotion Regulation Difficulties (Difficulties in Emotion Regulation Scale; DERS-16)
Difficulties in emotion regulation are assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16) in patients (and significant others) receiving NHV for severe self-harm or eating disorders. Total scores range from 16 to 80, with higher scores indicating greater difficulties in emotion regulation.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Social Safeness (Social Safeness and Pleasure Scale; SSPS)
Social safeness and positive experiences in social relationships are assessed using the 11-item Social Safeness and Pleasure Scale (SSPS) in both patient groups. Higher scores indicate greater feelings of social safeness, connectedness, and pleasure in social relationships.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Perceived Emotional Invalidation (Perceived Invalidation of Emotion Scale; PIES)
Perceived emotional invalidation is assessed using the Perceived Invalidation of Emotion Scale (PIES) in the self-harm-group (and significant others). The questionnaire assesses the extent to which individuals perceive that their emotions are misunderstood, dismissed, or invalidated by others. Higher scores indicate greater perceived emotional invalidation.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Self-Harm Behaviors Across Five Behavioral Categories (5S-HM)
Self-harm behaviors are assessed using the 26-item Five Self-Harm Behaviour Groupings Measure (5S-HM) in patients receiving NHV for severe self-harm. The instrument assesses five categories of behaviors: (1) direct physical self-injury, (2) neglect of physical needs, (3) sexual self-harm, (4) deliberate risk-taking and self-endangerment, and (5) suicide attempts. Each item assesses the frequency of behaviors during the preceding three months on a scale from 0 (never) to 8 (eight or more times). Mean scores are calculated separately for each of the five behavioral categories, with higher scores indicating more frequent behaviors. An overall total score is also calculated across all 26 items.
Time frame: At treatment start, treatment completion, 12 months and five years after treatment completion.
Change in Pain Experience and Pain Sensitivity (Adapted PrePain Questionnaire and Self-Harm-Related Pain Items)
Pain experience and sensitivity are assessed using selected items from the PrePain questionnaire (Gedin et al., 2025), supplemented with five study-specific items addressing pain associated with self-harm, in patients receiving NHV for severe self-harm. The PrePain items assess current pain and pain intensity across body regions (1-10), history and presence of long-term pain (four yes/no items), and perceived pain sensitivity (1-10). The additional items assess pain intensity, pain tolerance, positive experiences associated with pain, persistence of pain following self-harm (each rated from 1 to 10), and perceived differences in pain between self-injury involving skin damage and deliberate ingestion of harmful foreign objects. All items are evaluated separately, and no overall total score is calculated.
Time frame: At treatment start, treatment completion (approximately 12 weeks), 12 months and five years after treatment completion.
Change in Self-Harm Behaviors (Deliberate Self-Harm Inventory; DSHI-9), with two additional items, 1 week
Self-harm behaviors are assessed using a modified 9-item version of the Deliberate Self-Harm Inventory (DSHI-9), in which two items from the original questionnaire (items 1 and 2) have been combined into one to reduce respondent burden. The questionnaire is administered to patients receiving NHV for severe self-harm or eating disorders. The frequency of self-harm behaviors during the preceding 7 days is assessed, and changes are evaluated over time, with higher scores indicating more frequent self-harm. Two additional items assessing deliberate foreign body ingestion (DFBI) and intentional overdose are evaluated separately.
Time frame: Weekly during treatment
Change in Eating Disorder Symptoms (Eating Disorder Symptom List; EDSL), with two additional items
Eating disorder symptoms are assessed using the 8-item Eating Disorder Symptom List (EDSL) in patients receiving NHV for eating disorders or severe self-harm. The questionnaire assesses the frequency of eating disorder symptoms during the preceding seven days, with each item scored from 0 (no days) to 7 (every day). Total scores range from 0 to 56, with higher scores indicating more frequent eating disorder symptoms. Two additional items have been included to assess the total number of binge-eating episodes and purging episodes during the preceding seven days. These two items are evaluated separately and are not included in the total score.
Time frame: ED-patients: Weekly, SH-patients: At treatment start
Change in significant others' assessment of patient difficulties, coping skills, quality of life, and daily functioning (four Visual Analogue Scales; VAS)
Significant others' perceptions of patients receiving NHV for severe self-harm or eating disorders are assessed using four study-specific Visual Analogue Scales (VAS). The scales assess (1) the severity of the patient's mental health-related difficulties, (2) the patient's ability to cope with psychological distress, (3) the patient's quality of life, and (4) the patient's ability to function in daily life, including household activities, work, studies, parenting, social relationships, and leisure activities. Each dimension is rated separately on a scale from 0 to 10. Higher scores indicate greater perceived difficulties on the first scale and better coping skills, quality of life, and daily functioning on the remaining three scales. Daily functioning is assessed with reference to the preceding 30 days. No overall total score is calculated.
Time frame: At treatment start, treatment completion (approximately 12 weeks), 12 months and five years after treatment completion.
Plan to share: Undecided — The possibility of combining de-identified individual participant data across National Highly Specialized Care (NHV) units in Sweden is currently under discussion. No formal decision has been made, and the necessary ethical approvals have not yet been obtained. Any future data sharing would be subject to appropriate ethical and legal approvals and applicable data protection requirements.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2034, 100 months after the start.
Of 67 non-industry observational studies under Feeding and Eating Disorders, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 87. This study's planned 100 months is above that.
Counting every sponsor, half of 70 studies reached it within 42 months; a quarter within 16 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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