Eating Disorder SymptomNCT04665167
An Intervention for Eating and Body Image Concerns Among Young Adult Women
A study testing Body image exposure and Self-compassion in people with Eating Disorder Symptom and Body Image Disturbance, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eating Disorder Symptom, Body Image Disturbance
- What is being tested?
- Body image exposure and Self-compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2021to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body shape questionnaire score > 25
- Age ≥18
- Self-identified women
- Be able to use a computer and having an Internet connection and webcam
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Disorder Symptom, Body Image Disturbance
- Being tested
- Body image exposure, Self-compassion
- Keywords
- eating pathology, body image, exposure, self-compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body image exposureBehavioural
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.
Self-compassionBehavioural
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/.
| Study group | Role | What they receive |
|---|---|---|
| Body image exposure | Active comparator | Guided non-judgmental exposure, 40 minutes total Receives: Behavioral: Body image exposure |
| Self-compassion | Active comparator | 8 Short self-compassion meditations, 40 minutes total Receives: Behavioral: Self-compassion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited
30 participants
Measured: will measure upon study termination (estimated at 2-3 months)
Secondary outcomes (1)
The rate of completion
assessed by the percentage of participants who complete the study questionnaires
Measured: will measure upon study termination (estimated at 2-3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start13 Jan 2021
- Primary completion26 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fidan Turk, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665167
- Sponsor's protocol ID
- 168743
- Status last verified
- Aug 2020
- First submitted
- 23 Nov 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Franko DL, Striegel-Moore RH. The role of body dissatisfaction as a risk factor for depression in adolescent girls: are the differences Black and White? J Psychosom Res. 2002 Nov;53(5):975-83. doi: 10.1016/s0022-3999(02)00490-7.
PubMed 12445587
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Online Exposure Therapy and Self-compassion Interventions for Eating and Body Image Concerns Among Young Adult Women
- ClinicalTrials.gov ID
- NCT04665167
- Acronym / sponsor ID
- 168743
- Conditions
- Eating Disorder Symptom, Body Image Disturbance
- Keywords
- eating pathology, body image, exposure, self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body image exposure | Active comparator | Behavioral: Body image exposureGuided non-judgmental exposure, 40 minutes total |
| Self-compassion | Active comparator | Behavioral: Self-compassion8 Short self-compassion meditations, 40 minutes total |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body shape questionnaire score > 25
- Age ≥18
- Self-identified women
- Be able to use a computer and having an Internet connection and webcam
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body image exposureExposure 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. | Behavioural | Body image exposure |
| Self-compassionThe 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/. | Behavioural | Self-compassion |
Primary outcome
Number of participants recruited
Time frame: will measure upon study termination (estimated at 2-3 months)
30 participants
1 secondary outcome
The rate of completion
Time frame: will measure upon study termination (estimated at 2-3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 12445587Franko DL, Striegel-Moore RH. The role of body dissatisfaction as a risk factor for depression in adolescent girls: are the differences Black and White? J Psychosom Res. 2002 Nov;53(5):975-83. doi: 10.1016/s0022-3999(02)00490-7.
- NICE, 2017. Eating disorders: recognition and treatmentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fidan Turk principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body image exposure and Self-compassion in people with Eating Disorder Symptom and Body Image Disturbance, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruited (time frame: will measure upon study termination (estimated at 2-3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.