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An Intervention for Eating and Body Image Concerns Among Young Adult Women

Primary Purpose

Eating Disorder Symptom, Body Image Disturbance

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Body image exposure

Self-compassion

About this trial

This is an interventional prevention trial for Eating Disorder Symptom focused on measuring eating pathology, body image, exposure, self-compassion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Sheffield

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Body image exposure

Self-compassion

Arm Description

Guided non-judgmental exposure, 40 minutes total

8 Short self-compassion meditations, 40 minutes total

Outcomes

Primary Outcome Measures

Number of participants recruited

30 participants

Secondary Outcome Measures

The rate of completion

assessed by the percentage of participants who complete the study questionnaires

Full Information

NCT ID

NCT04665167

First Posted

November 23, 2020

Last Updated

April 7, 2021

Sponsor

University of Sheffield

1. Study Identification

Unique Protocol Identification Number

NCT04665167

Brief Title

An Intervention for Eating and Body Image Concerns Among Young Adult Women

Official Title

Feasibility of Online Exposure Therapy and Self-compassion Interventions for Eating and Body Image Concerns Among Young Adult Women

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

January 13, 2021 (Actual)

Primary Completion Date

February 26, 2021 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sheffield

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eating Disorder Symptom, Body Image Disturbance

Keywords

eating pathology, body image, exposure, self-compassion

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Body image exposure

Arm Type

Active Comparator

Arm Description

Guided non-judgmental exposure, 40 minutes total

Arm Title

Self-compassion

Arm Type

Active Comparator

Arm Description

8 Short self-compassion meditations, 40 minutes total

Intervention Type

Behavioral

Intervention Name(s)

Body image exposure

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Self-compassion

Intervention Description

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/.

Primary Outcome Measure Information:

Title

Number of participants recruited

Description

30 participants

Time Frame

will measure upon study termination (estimated at 2-3 months)

Secondary Outcome Measure Information:

Title

The rate of completion

Description

assessed by the percentage of participants who complete the study questionnaires

Time Frame

will measure upon study termination (estimated at 2-3 months)

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Self-identified women

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fidan Turk

Organizational Affiliation

University of Sheffield

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Sheffield

City

Sheffield

ZIP/Postal Code

S1 2LT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

12445587

Citation

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.

Results Reference

background

Links:

URL

http://www.nice.org.uk/guidance/ng69/resources/eating-disorders-recognition-and-treatment-pdf-1837582159813

Description

NICE, 2017. Eating disorders: recognition and treatment

Learn more about this trial

An Intervention for Eating and Body Image Concerns Among Young Adult Women

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