Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665167
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sheffield

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.

Condition or disease Intervention/treatment Phase
Eating Disorder Symptom Body Image Disturbance Behavioral: Body image exposure Behavioral: Self-compassion Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of Online Exposure Therapy and Self-compassion Interventions for Eating and Body Image Concerns Among Young Adult Women
Actual Study Start Date : January 13, 2021
Actual Primary Completion Date : February 26, 2021
Actual Study Completion Date : March 30, 2021

Arm Intervention/treatment
Active Comparator: Body image exposure
Guided non-judgmental exposure, 40 minutes total
Behavioral: Body image exposure
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.

Active Comparator: Self-compassion
8 Short self-compassion meditations, 40 minutes total
Behavioral: Self-compassion
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 Measures :
  1. Number of participants recruited [ Time Frame: will measure upon study termination (estimated at 2-3 months) ]
    30 participants


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identified women
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665167


Locations
Layout table for location information
United Kingdom
University of Sheffield
Sheffield, United Kingdom, S1 2LT
Sponsors and Collaborators
University of Sheffield
Investigators
Layout table for investigator information
Principal Investigator: Fidan Turk University of Sheffield
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: University of Sheffield
ClinicalTrials.gov Identifier: NCT04665167    
Other Study ID Numbers: 168743
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sheffield:
eating pathology
body image
exposure
self-compassion
Additional relevant MeSH terms:
Layout table for MeSH terms
Feeding and Eating Disorders
Mental Disorders