NCT03673982

Brief Summary

To improve treatment for patients with severe anorexia nervosa admitted for inpatient care, and to help their families. Inpatients and their families will be offered a novel intervention which includes multimedia training materials. These materials provide guidance in how families can provide support to maintain and build on changes made during inpatient care

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

March 16, 2017

Last Update Submit

September 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight change

    weight change over the admission (weight and height will be combined to report BMI in kg/m\^2)

    at time of admission, at time of discharge (average 12-14 weeks)

Secondary Outcomes (4)

  • Self-Report Questionnaires to assess psychopathological change for patients over admission and post-discharge.

    Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.

  • Self-Report Questionnaires for carers, to assess change in perceived burden over admission and post-discharge.

    Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.

  • Self-Report Questionnaires for carers, to assess change in perceived confidence over admission and post-discharge.

    Questionnaires are administered at time of admission, at time of discharge (average 12-14 weeks) and 3 months post-discharge.

  • Patient satisfaction

    at 3 months post-discharge.

Study Arms (1)

iCASK Group

EXPERIMENTAL

Materials and support to aid transitions.

Behavioral: iCASK

Interventions

iCASKBEHAVIORAL

Materials and support to aid transitions

iCASK Group

Eligibility Criteria

Age17 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • aged 17 or over
  • DSM-5 diagnosis of Anorexia Nervosa with a body mass index (BMI) of \< 18.5 kg/m2

You may not qualify if:

  • Insufficient knowledge of English
  • Severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tyson West 2, Bethlem Royal Hospital

Beckenham, Kent, BR3 3BX, United Kingdom

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Janet Treasure, Prof

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

March 16, 2017

First Posted

September 17, 2018

Study Start

January 9, 2017

Primary Completion

January 25, 2018

Study Completion

August 30, 2018

Last Updated

September 17, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations