Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-01 @ 3:39 AM
Study NCT ID:
NCT04060433
Status:
UNKNOWN
Last Update Posted:
2020-09-03
First Post:
2019-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Evidence-Based Treatment of Restrictive Eating Disorder With Pronounced Starvation
Sponsor:
Lund University Hospital
Organization:
Study Overview
Official 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
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROCKETLAUNCH
Brief Summary:
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.
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.
Detailed Description:
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.
1. At treatment start
2. After one month
3. At one year follow-up.
The investigators are going to evaluate:
1. The implementation, how the clinical organization and the therapists follow the treatment protocol.
2. The waiting time and the frequency of treatment sessions.
3. Amount of in-patient care.
4. The outcome of the patient, with focus on weight gain and medical stabilization. The investigators will also look at psychological improvement, and evaluate the improvement in specific eating disorders psychopathology and improvement in general psychiatric psychopathology.
5. The health economic cost. The main outcome variables, such as weight gain, waiting time, frequency of treatment sessions and amount of inpatient care will be compared with the patients and families who have been in treatment before the ROCKETLAUNCH project started.
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.
1. At treatment start
2. After one month
3. At one year follow-up.
The investigators are going to evaluate:
1. The implementation, how the clinical organization and the therapists follow the treatment protocol.
2. The waiting time and the frequency of treatment sessions.
3. Amount of in-patient care.
4. The outcome of the patient, with focus on weight gain and medical stabilization. The investigators will also look at psychological improvement, and evaluate the improvement in specific eating disorders psychopathology and improvement in general psychiatric psychopathology.
5. The health economic cost. The main outcome variables, such as weight gain, waiting time, frequency of treatment sessions and amount of inpatient care will be compared with the patients and families who have been in treatment before the ROCKETLAUNCH project started.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: