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

Primary Purpose

Anorexia Nervosa, Anorexia Nervosa, Atypical, Avoidant/Restrictive Food Intake Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Family Therapy
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Family Therapy, Health Plan Implementation, Outpatients

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatry Skane, Lund University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ROCKETLAUNCH project

Arm Description

Intensive treatment program with focusing on the implementation of evidence based family therapy

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)
Change from baseline Body Mass Index (weight in kg/height in m²) at 1 month and 12 months
Medical stabilization
Rate of particapants that have normalized pulse rate and blood pressure.

Secondary Outcome Measures

In-patient treatment
Amount of days the patient needs to be hospitalized due to somatic danger
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.
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.

Full Information

First Posted
August 12, 2019
Last Updated
September 1, 2020
Sponsor
Lund University Hospital
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT04060433
Brief Title
Implementation of Evidence-Based Treatment of Restrictive Eating Disorder With Pronounced Starvation
Acronym
ROCKETLAUNCH
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
January 20, 2023 (Anticipated)
Study Completion Date
February 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University Hospital
Collaborators
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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. At treatment start After one month At one year follow-up. The investigators are going to evaluate: The implementation, how the clinical organization and the therapists follow the treatment protocol. The waiting time and the frequency of treatment sessions. Amount of in-patient care. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Anorexia Nervosa, Atypical, Avoidant/Restrictive Food Intake Disorder, Starvation
Keywords
Family Therapy, Health Plan Implementation, Outpatients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ROCKETLAUNCH project
Arm Type
Experimental
Arm Description
Intensive treatment program with focusing on the implementation of evidence based family therapy
Intervention Type
Behavioral
Intervention Name(s)
Family Therapy
Intervention Description
Swedish version of the evidence based manualized Family Therapy
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
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
Title
Medical stabilization
Description
Rate of particapants that have normalized pulse rate and blood pressure.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
In-patient treatment
Description
Amount of days the patient needs to be hospitalized due to somatic danger
Time Frame
1 month and 12 months
Title
Change from baseline nature and seriousness of eating-disorder symptoms at 1 months and 12 months
Description
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
Title
Change from baseline patient's emotional symptoms at 1 month and 12 months
Description
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
Other Pre-specified Outcome Measures:
Title
Therapists treatment fidelity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulf Wallin, MD PhD
Phone
+46702202540
Email
ulf.wallin@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf G Wallin, MD PhD
Organizational Affiliation
Head of Research and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatry Skane, Lund University Hospital
City
Lund
State/Province
Skane
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulf G Wallin, MD, PhD
Phone
+46702202540
Email
ulf.wallin@skane.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32153439
Citation
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.
Results Reference
derived

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

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