An interventional study of Family Therapy in Anorexia Nervosa, Anorexia Nervosa, Atypical and Avoidant/Restrictive Food Intake Disorder, sponsored by Lund University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Lund University Hospital · Not applicable, Interventional, and Treatment
In the Region Skåne in Sweden, the investigators have developed guidelines for providing intensive and evidence-based treatment during the first month in case of severe restrictive eating disorder with pronounced starvation.
The project is aiming at implementing this treatment program in the general Child Psychiatric clinic, with its main focus on the implementation of evidence based family therapy. The study aims to evaluate the implementation of a standardized treatment model during the first month. The outcome will be compared with the patients and families who have been in treatment before the ROCKETLAUNCH project started.
Anorexia nervosa and other restrictive eating disorders with pronounced starvation is one of the most acute and life-threatening conditions in child psychiatry and requires immediate treatment. Anorexia nervosa is the eating disorder which most often causes pronounced starvation, and also has the highest mortality in psychiatry. These conditions are hard to treat, and there are not many successful treatment methods. Family therapy, and more specific family based treatment has so far proved to be the most successful treatment method for the young patient with anorexia nervosa.
For patients presenting with severe underweight, it is critically important to treat starvation and achieve medical stabilization and weight gain as the first priority. Research shows that weight gain during the first month of treatment produces a better outcome. Family-based treatment has the best evidence support to achieve early weight gain for adolescents with anorexia nervosa.
In child and adolescent psychiatry in the Region Skåne in Sweden, a working group have developed guidelines for providing intensive and evidence-based treatment during the first month in case of severe restrictive eating disorder with pronounced starvation.
Whenever a young person diagnosed with an eating disorder is suspected to suffer from starvation, an assessment shall be offered promptly, normally at the latest within fourteen days. If significant cardiac symptoms are reported, assessment must be made within a few days. The treating service should be prepared to offer at least 1-2 visits a week directly at treatment start.
The high-intensity treatment focuses on medical stabilization and weight gain from the first visit. The goal of the treatment during the first month is weight gain of at least 2 kg (exception made for atypical anorexia nervosa with a normal or high weight - where the goal is to achieve medical stabilization). The focus is on helping the patient to conquer starvation. Interventions for normalizing eating will continue after this period.
The project is aiming at implementing this treatment program in the general child psychiatric clinic, with its main focus on the implementation of evidence based family therapy. In the project the investigators have developed two treatment manuals, one for the general family treatment during the first month and one for the family meal.
12 child psychiatric outpatient clinics in the south of Sweden will take part. The study aims to evaluate the implementation of a standardized treatment model during the first month.
The ROCKETLAUNCH project will be running for three years. The study will gather data at three time points.
The investigators are going to evaluate:
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's planned enrollment of 300 is above the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →Lund University Hospital is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intensive treatment program with focusing on the implementation of evidence based family therapy
Behavioral: Family Therapy
Swedish version of the evidence based manualized Family Therapy
Body Mass Index (BMI)
Change from baseline Body Mass Index (weight in kg/height in m²) at 1 month and 12 months
Time frame: 1 month and 12 months
Medical stabilization
Rate of particapants that have normalized pulse rate and blood pressure.
Time frame: 1 month
In-patient treatment
Amount of days the patient needs to be hospitalized due to somatic danger
Time frame: 1 month and 12 months
Change from baseline nature and seriousness of eating-disorder symptoms at 1 months and 12 months
Patients will complete EDE-Q (Eating Disorder Examination - questionnaire) at baseline, after 1 month and after 12 months. A self-assessment form for eating disorder symptoms.
Time frame: 1 month and 12 months
Change from baseline patient's emotional symptoms at 1 month and 12 months
Patients will complete RCADS (Revised Child Anxiety and Depression Scales) at baseline, after 1 month and after 12 months. The RCADS is a 47-item self-report questionnaire, with scales corresponding to separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). The RCADS requires respondents to rate how often each item applies to them. Items are scored 0-3 corresponding to ''never,'' ''sometimes,'' ''often,'' and ''always.'' Higher values represent a worse outcome.
Time frame: 1 month and 12 months
Therapists treatment fidelity
Percentage of therapists in the study that follow the Swedish Family Therapy for Eating Disorders treatment manual. This will be measured with a questionnaire constructed from the treatment manual and will capture the essential treatment interventions.
Time frame: 1 month
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Starvation
Lund University Hospital