NCT04665167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

April 8, 2021

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

November 23, 2020

Last Update Submit

April 7, 2021

Conditions

Eating Disorder SymptomBody Image Disturbance

Keywords

eating pathologybody imageexposureself-compassion

Outcome Measures

Primary Outcomes (1)

  • Number of participants recruited

    30 participants

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

Secondary Outcomes (1)

  • The rate of completion

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

Study Arms (2)

Body image exposure

ACTIVE COMPARATOR

Guided non-judgmental exposure, 40 minutes total

Behavioral: Body image exposure

Self-compassion

ACTIVE COMPARATOR

8 Short self-compassion meditations, 40 minutes total

Behavioral: Self-compassion

Interventions

Body image exposureBEHAVIORAL

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.

Body image exposure
Self-compassionBEHAVIORAL

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/.

Self-compassion

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body shape questionnaire score \> 25
  • Age ≥18
  • Self-identified women
  • Be able to use a computer and having an Internet connection and webcam

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sheffield

Sheffield, S1 2LT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 12445587BACKGROUND

Related Links

Study Officials

  • Fidan Turk

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 11, 2020

Study Start

January 13, 2021

Primary Completion

February 26, 2021

Study Completion

March 30, 2021

Last Updated

April 8, 2021

Record last verified: 2020-08

Locations

GB(1)