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Anorexia NervosaROCKETLAUNCHNCT04060433

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

A study testing Family Therapy in people with Anorexia Nervosa and Anorexia Nervosa, Atypical, run by Lund University Hospital at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 17 years
What is being tested?
Family Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSweden
Study dates
1 Oct 2020to 20 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ulf Wallin, MD PhD contact

+46702202540

ulf.wallin@skane.se

Sweden1 site, 1 recruiting
  • Psychiatry Skane, Lund University Hospital

    Lund, Skåne County, 221 85

    Ulf G Wallin, MD, PhD, +46702202540, ulf.wallin@skane.se

    Recruiting

Other trials in Sweden

About this study

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.

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.
Being tested
Family Therapy
Keywords
Family Therapy, Health Plan Implementation, Outpatients
Medical subject headings
Anorexia Nervosa, Avoidant Restrictive Food Intake Disorder, Starvation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family TherapyBehavioural

    Swedish version of the evidence based manualized Family Therapy

Study groups in NCT04060433
Study groupRoleWhat they receive
ROCKETLAUNCH projectExperimentalIntensive treatment program with focusing on the implementation of evidence based family therapy
Receives: Behavioral: Family Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index (BMI)

    Change from baseline Body Mass Index (weight in kg/height in m²) at 1 month and 12 months

    Measured: 1 month and 12 months

  2. Medical stabilization

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

    Measured: 1 month

Secondary outcomes (3)
  1. In-patient treatment

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

    Measured: 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.

    Measured: 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.

    Measured: 1 month and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2019
  2. Study start1 Oct 2020 (estimated)
  3. Primary completion20 Jan 2023 (estimated)
  4. Study completion20 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04060433
Sponsor's protocol ID
Dnr 2019-01852
Acronym
ROCKETLAUNCH
Status last verified
Sep 2020
First submitted
12 Aug 2019
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Family Therapy in people with Anorexia Nervosa and Anorexia Nervosa, Atypical, run by Lund University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ulf Wallin, MD PhD (+46702202540, ulf.wallin@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (BMI) (time frame: 1 month and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04060433, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.

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