- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04665167
An Intervention for Eating and Body Image Concerns Among Young Adult Women
April 7, 2021 updated by: University of Sheffield
Feasibility of Online Exposure Therapy and Self-compassion Interventions for Eating and Body Image Concerns Among Young Adult Women
The primary aim of the current study is to assess acceptability and feasibility of online body image exposure and self-compassion interventions before conducting a larger RCT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will determine the feasibility and effectiveness of delivering an online therapy for eating pathology and body image disturbance.
It will address body image and eating pathology in a non-clinical group of young adult women, who are at risk of developing such problems .
The feasibility study will determine whether there are any difficulties that would need to be addressed in recruitment, online delivery and assessment of those treatments.
Study Type
Interventional
Enrollment (Actual)
30
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
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Sheffield, United Kingdom, S1 2LT
- University of Sheffield
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Body shape questionnaire score > 25
- Age ≥18
- Self-identified women
- Be able to use a computer and having an Internet connection and webcam
Exclusion Criteria:
- Insufficient knowledge of English
- Learning disability, severe mental illness or alcohol/substance dependence, history of self-injuries, current eating disorder, current clinical depression
- Psychiatric illness requiring secondary care intervention
- Male
- Under 18 years old
- Body mass index below 18.5
- Currently undergoing psychological therapies
- No access to a tablet or computer with an internet connection
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Body image exposure
Guided non-judgmental exposure, 40 minutes total
|
Exposure therapy is a key element of evidence-based cognitive behaviour therapy for eating disorders .
Body image exposure intervention involves deliberate, planned, and systematic exposure to the body image.
Participants will be asked to stand so that they can see their whole body - far enough back.
Participants will be asked to look at their bodies on screen.
Participants will be continually encouraged by the facilitator for looking at and talking about the body parts.
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|
Active Comparator: Self-compassion
8 Short self-compassion meditations, 40 minutes total
|
The self-compassion intervention condition consists of Neff's self-compassion exercises.
These exercises are part of the self-compassion intervention condition.
Meditation text used in this study is obtained from the following link https://self-compassion.org/category/exercises/.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants recruited
Time Frame: will measure upon study termination (estimated at 2-3 months)
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30 participants
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will measure upon study termination (estimated at 2-3 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of completion
Time Frame: will measure upon study termination (estimated at 2-3 months)
|
assessed by the percentage of participants who complete the study questionnaires
|
will measure upon study termination (estimated at 2-3 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fidan Turk, University of Sheffield
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
January 13, 2021
Primary Completion (Actual)
February 26, 2021
Study Completion (Actual)
March 30, 2021
Study Registration Dates
First Submitted
November 23, 2020
First Submitted That Met QC Criteria
December 9, 2020
First Posted (Actual)
December 11, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2021
Last Update Submitted That Met QC Criteria
April 7, 2021
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 168743
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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