Implementation of Evidence-Based Treatment of Restrictive Eating Disorder With Pronounced Starvation (ROCKETLAUNCH)

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.

Study Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa; Avoidant/Restrictive Food Intake Disorder; Starvation; Anorexia Nervosa, Atypical
• Intervention / Treatment: Behavioral: Family Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulf Wallin, MD PhD; Phone Number: +46702202540; Email: ulf.wallin@skane.se

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 221 85
      • Recruiting
      • Psychiatry Skane, Lund University Hospital
      • Contact: Ulf G Wallin, MD, PhD; Phone Number: +46702202540; Email: ulf.wallin@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ROCKETLAUNCH project; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Medical stabilization	Rate of particapants that have normalized pulse rate and blood pressure.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-patient treatment	Amount of days the patient needs to be hospitalized due to somatic danger	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.	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.	1 month and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lund University Hospital
• Collaborators: Lund University
• Investigators: Principal Investigator: Ulf G Wallin, MD PhD, Head of Research and Development

Publications and helpful links

General Publications

• Wallin U, Saha S. Implementation of Key Components of Evidence-Based Family Therapy for Eating Disorders in Child and Adolescent Psychiatric Outpatient Care. Front Psychiatry. 2020 Feb 20;11:59. doi: 10.3389/fpsyt.2020.00059. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): January 20, 2023
• Study Completion (ANTICIPATED): February 20, 2025

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (ACTUAL): August 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Outpatients; Family Therapy; Health Plan Implementation
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Nutrition Disorders; Malnutrition; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder; Starvation
• Other Study ID Numbers: Dnr 2019-01852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No