Anorexia Nervosa Clinical Trial
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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05531604 -
Appetitive Conditioning in Anorexia Nervosa
|
||
Enrolling by invitation |
NCT04174703 -
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
|
N/A | |
Active, not recruiting |
NCT04883554 -
Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study
|
N/A | |
Recruiting |
NCT04213820 -
TMS and Body Image Treatment for Anorexia Nervosa
|
N/A | |
Completed |
NCT03414112 -
The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa
|
Early Phase 1 | |
Recruiting |
NCT06144905 -
Norwegian Microbiota Study in Anorexia Nervosa
|
||
Recruiting |
NCT05803707 -
Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study
|
N/A | |
Recruiting |
NCT05682417 -
Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa
|
N/A | |
Not yet recruiting |
NCT06380257 -
Anorexia Nervosa and Brain in Adolescence
|
||
Not yet recruiting |
NCT04804800 -
Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa
|
N/A | |
Not yet recruiting |
NCT03600610 -
Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa
|
N/A | |
Completed |
NCT02745067 -
Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa
|
N/A | |
Completed |
NCT02382055 -
Changing Habits in Anorexia Nervosa: Novel Treatment Development
|
N/A | |
Completed |
NCT03075371 -
Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa
|
N/A | |
Terminated |
NCT02240797 -
Kappa Opioid Receptor Imaging in Anorexia
|
N/A | |
Unknown status |
NCT01761942 -
Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa
|
Phase 2 | |
Completed |
NCT03144986 -
Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa
|
N/A | |
Completed |
NCT02551445 -
A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders.
|
N/A | |
Completed |
NCT01579682 -
Adaptive Family Treatment for Adolescent Anorexia Nervosa
|
N/A | |
Completed |
NCT00946816 -
The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
|
N/A |