Back to resultsEvaluation of Compulsive Exercise Group Therapy for Eating Disorders
Primary Purpose
Eating Disorders in Adolescence
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Newbridge Eating disorders Activity Treatment group
Newbridge House treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders in Adolescence
Eligibility Criteria
Inclusion Criteria:
- Inpatients at Newbridge House
- Aged 11-18
- Primary diagnosis of any form of eating disorder
- Females
Exclusion Criteria:
- 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
Sites / Locations
- Newbridge HouseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as usual
Treatment as usual and NEAT group
Arm Description
Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, excluding the NEAT group.
Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, alongside NEAT group.
Outcomes
Primary Outcome Measures
Change in Compulsive Exercise Test
Secondary Outcome Measures
Change in Eating Disorder Examination Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04552639
Brief Title
Evaluation of Compulsive Exercise Group Therapy for Eating Disorders
Official Title
A Randomized Control Trial Study Evaluating a Compulsive Exercise Group for Adolescent Inpatients With Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Newbridge House
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders in Adolescence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
There is an external statistician who will assess the outcomes.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, excluding the NEAT group.
Arm Title
Treatment as usual and NEAT group
Arm Type
Experimental
Arm Description
Treatment as usual is offered. This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, alongside NEAT group.
Intervention Type
Behavioral
Intervention Name(s)
Newbridge Eating disorders Activity Treatment group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Newbridge House treatment as usual
Intervention Description
Multi-disciplinary eating disorder treatment (including; psychiatry, individual therapy, group therapy, dietetic support, occupation therapy and nursing excluding NEAT group).
Primary Outcome Measure Information:
Title
Change in Compulsive Exercise Test
Time Frame
Week 1 and week 7
Secondary Outcome Measure Information:
Title
Change in Eating Disorder Examination Questionnaire
Time Frame
Week 1 and week 7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatients at Newbridge House
Aged 11-18
Primary diagnosis of any form of eating disorder
Females
Exclusion Criteria:
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
Facility Information:
Facility Name
Newbridge House
City
Birmingham
ZIP/Postal Code
B74 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Matthews
Phone
01212273891
Ext
01212273891
Email
rachel.matthews@newbridge-health.org.uk
First Name & Middle Initial & Last Name & Degree
Hubert Professor Lacey
Phone
01212273891
Ext
01212273891
Email
jhubertlacey@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gurdeep Aulakh, BSc (hons) Psychology
First Name & Middle Initial & Last Name & Degree
Pria Sandhu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Compulsive Exercise Group Therapy for Eating Disorders
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