CClinicalTrials.gg
Status unknownNCT04060433ROCKETLAUNCHUpdated Sep 3, 2020

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

An interventional study of Family Therapy in Anorexia Nervosa, Anorexia Nervosa, Atypical and Avoidant/Restrictive Food Intake Disorder, sponsored by Lund University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Lund University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
7 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

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

Keywords

  • Family Therapy
  • Health Plan Implementation
  • Outpatients
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's planned enrollment of 300 is above the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Lund University Hospital is the lead sponsor of 64 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    ROCKETLAUNCH project

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

    Behavioral: Family Therapy

Interventions

  • BehavioralFamily Therapy

    Swedish version of the evidence based manualized Family Therapy

06

What researchers measure

Primary outcomes

  1. Body Mass Index (BMI)

    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

  2. Medical stabilization

    Rate of particapants that have normalized pulse rate and blood pressure.

    Time frame: 1 month

Secondary outcomes

  1. In-patient treatment

    Amount of days the patient needs to be hospitalized due to somatic danger

    Time frame: 1 month and 12 months

  2. 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.

    Time frame: 1 month and 12 months

  3. 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.

    Time frame: 1 month and 12 months

Other outcomes

  1. 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.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Psychiatry Skane, Lund University Hospital
    Lund, Skane 221 85, Sweden
    Recruiting
08

References and documents

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. PubMed 32153439 ↗

Study documents

  • Study protocol · Aug 13, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04060433
Lead sponsor
Lund University Hospital
Collaborators
Lund University
Responsible party
Ulf Wallin (MD, PhD Head of Research and Development, Lund University Hospital) — Principal investigator
First posted
Aug 19, 2019
Start date
Oct 1, 2020 (estimated)
Primary completion
Jan 20, 2023 (estimated)
Completion
Feb 20, 2025 (estimated)
Last update
Sep 3, 2020

Study contacts

Ulf Wallin, MD PhD
Contact
ulf.wallin@skane.se
+46702202540
Ulf G Wallin, MD PhD
principal investigator · Head of Research and Development

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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