- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552639
Evaluation of Compulsive Exercise Group Therapy for Eating Disorders
September 1, 2021 updated by: Gurdeep Aulakh, Newbridge House
A Randomized Control Trial Study Evaluating a Compulsive Exercise Group for Adolescent Inpatients With Eating Disorders
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Birmingham, United Kingdom, B74 3NE
- Recruiting
- Newbridge House
-
Contact:
- Rachel Matthews
- Phone Number: 01212273891 01212273891
- Email: rachel.matthews@newbridge-health.org.uk
-
Contact:
- Hubert Professor Lacey
- Phone Number: 01212273891 01212273891
- Email: jhubertlacey@hotmail.com
-
Principal Investigator:
- Gurdeep Aulakh, BSc (hons) Psychology
-
Sub-Investigator:
- Pria Sandhu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment as usual
Treatment as usual is offered.
This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, excluding the NEAT group.
|
Multi-disciplinary eating disorder treatment (including; psychiatry, individual therapy, group therapy, dietetic support, occupation therapy and nursing excluding NEAT group).
|
|
Experimental: Treatment as usual and NEAT group
Treatment as usual is offered.
This includes; individual therapy, group therapy, dietetic support, occupational therapy, nursing and psychiatry, alongside NEAT group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Compulsive Exercise Test
Time Frame: Week 1 and week 7
|
Week 1 and week 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Eating Disorder Examination Questionnaire
Time Frame: Week 1 and week 7
|
Week 1 and week 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
August 21, 2020
First Submitted That Met QC Criteria
September 11, 2020
First Posted (Actual)
September 17, 2020
Study Record Updates
Last Update Posted (Actual)
September 2, 2021
Last Update Submitted That Met QC Criteria
September 1, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 281456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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