NCT04552639

Brief Summary

The study aims to generate hypotheses about whether a group intervention is effective in reducing motivation to compulsive exercise and/or eating disorder psychopathology when compared with a control group. This will be explored through a Randomized Control Trial.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration 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 21, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

August 21, 2020

Last Update Submit

September 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Compulsive Exercise Test

    Week 1 and week 7

Secondary Outcomes (1)

  • Change in Eating Disorder Examination Questionnaire

    Week 1 and week 7

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, excluding the NEAT group.

Behavioral: Newbridge House treatment as usual

Treatment as usual and NEAT group

EXPERIMENTAL

Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, alongside NEAT group.

Behavioral: Newbridge Eating disorders Activity Treatment group

Interventions

A compulsive exercise cognitive-behavioural based group, for children and adolescents diagnosed with an eating disorder. It was devised for eating disorders including Anorexia Nervosa, Bulimia Nervosa and Other Specified Feeding or Eating Disorder. This treatment is semi-structured and problem-oriented, which focuses on tackling the factors and processes that maintain compulsive exercise behaviour.

Treatment as usual and NEAT group

Multi-disciplinary eating disorder treatment (including; psychiatry, individual therapy, group therapy, dietetic support, occupation therapy and nursing excluding NEAT group).

Treatment as usual

Eligibility Criteria

Age11 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Inpatients at Newbridge House
  • Aged 11-18
  • Primary diagnosis of any form of eating disorder
  • Females

You may not qualify if:

  • Previously received NEAT group at Newbridge House
  • Aged under 10 years
  • Severe learning disability
  • Inpatients without compulsive exercise behaviours
  • Day patients
  • Co-morbid psychosis
  • Males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newbridge House

Birmingham, B74 3NE, United Kingdom

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
There is an external statistician who will assess the outcomes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Psychologist

Study Record Dates

First Submitted

August 21, 2020

First Posted

September 17, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

December 31, 2022

Last Updated

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations