Anorexia Nervosa Clinical Trial
— ROCKETLAUNCHOfficial title:
Implementation and Evaluation of a Standardized Protocol for Treatment of Restrictive Eating Disorders With Pronounced Starvation During the First Month in Child Psychiatric Outpatient Care. The ROCKETLAUNCH Project
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | February 20, 2025 |
Est. primary completion date | January 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Patient suffering from one in three restrictive Eating Disorders according to DSM-5 criteria: Anorexia Nervosa, Atypical Anorexia Nervosa or Avoidant/Restrictive Food Intake Disorder - Patient with pronounced starvation - Patient aged between 7 and 17 - Patient and his/her parents who accept to participate to the study - Patient comes to treatment for the first time. Exclusion Criteria: - Patient who is diagnosed with: psychosis, mental deficiency, organic cerebral disorder, any pathology that interfere with feeding or its regurgitation - Patient who does not speak Swedish - Patient who is already in family therapy for an other condition |
Country | Name | City | State |
---|---|---|---|
Sweden | Psychiatry Skane, Lund University Hospital | Lund | Skane |
Lead Sponsor | Collaborator |
---|---|
Lund University Hospital | Lund University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 1 month | |
Primary | Body Mass Index (BMI) | Change from baseline Body Mass Index (weight in kg/height in m²) at 1 month and 12 months | 1 month and 12 months | |
Primary | Medical stabilization | Rate of particapants that have normalized pulse rate and blood pressure. | 1 month | |
Secondary | In-patient treatment | Amount of days the patient needs to be hospitalized due to somatic danger | 1 month and 12 months | |
Secondary | 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. | 1 month and 12 months | |
Secondary | 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. | 1 month and 12 months |
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