NCT04060433

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

August 12, 2019

Last Update Submit

September 1, 2020

Conditions

Anorexia NervosaAnorexia Nervosa, AtypicalAvoidant/Restrictive Food Intake DisorderStarvation

Keywords

Family TherapyHealth Plan ImplementationOutpatients

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • In-patient treatment

    1 month and 12 months

  • Change from baseline nature and seriousness of eating-disorder symptoms at 1 months and 12 months

    1 month and 12 months

  • Change from baseline patient's emotional symptoms at 1 month and 12 months

    1 month and 12 months

Other Outcomes (1)

  • Therapists treatment fidelity

    1 month

Study Arms (1)

ROCKETLAUNCH project

EXPERIMENTAL

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

Behavioral: Family Therapy

Interventions

Family TherapyBEHAVIORAL

Swedish version of the evidence based manualized Family Therapy

ROCKETLAUNCH project

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatry Skane, Lund University Hospital

Lund, Skåne County, 221 85, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32153439DERIVED

MeSH Terms

Conditions

Anorexia NervosaAvoidant Restrictive Food Intake DisorderStarvation

Interventions

Family Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ulf G Wallin, MD PhD

    Head of Research and Development

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulf Wallin, MD PhD

CONTACT

+46702202540ulf.wallin@skane.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Head of Research and Development

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 19, 2019

Study Start

October 1, 2020

Primary Completion

January 20, 2023

Study Completion

February 20, 2025

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)