Testing a Brief and Low Intensity Self-compassion Intervention

Body Image Clinical Trial

Official title:

Testing a Brief and Low Intensity Self-compassion Intervention for State Body Shame Among Adult Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984252
• Other study ID #: 040360
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: September 18, 2021

Study information

• Verified date: September 2021
• Source: University of Sheffield
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators' recent feasibility trial of a self-compassion and active control intervention showed that the self-compassion intervention was promising in reducing state body shame during a 40-minute intervention session. There were three time points where the reduction in the body shame level was significant, indicating three active components in the intervention that led to significant reduction in state body shame. It is unclear if a shorter self-compassion intervention based on only the active components would be as effective as the longer intervention at reducing state body shame. Such a short intervention then could be used as an in-session change method (15-20 mins) as part of a larger package, or as a homework exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 18, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Self-identified women
• Be able to use a computer and have an Internet connection

Exclusion Criteria:

• Insufficient knowledge of English
• Learning disability or psychiatric illness requiring secondary care intervention
• Male
• Under 18 years old
• No access to a tablet or computer with an internet connection
• Body mass index below 18.5

Related Conditions & MeSH terms

• Body Image
• Body Image Disturbance
• Shame

Intervention

Behavioral:
• Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice
This intervention includes 3 short meditations that are identified as the active component in the previous study (ID: NCT04665167)
• Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise.
This intervention includes 3 short meditations that are identified as the inactive component in the previous study (ID: NCT04665167)
• Distraction group
Participants will be asked to listen recording on irrelevant topic.

Locations

Country	Name	City	State
United Kingdom	Fidan Turk	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Subjective units of shame (SUS) at the end of the intervention	Subjective units of shame (SUS), taken at four points during the intervention (scored 0 no shame to 100 full of shame)	through study completion, an average of 3 months
Secondary	Body Image States Scale	It will be used to assess transient feelings about the body and physical appearance. A 6-item scale measures current body-image experiences at a particular point in time or in a specific context. Possible scores range from 6 to 54, and higher scores indicate more positive body image (better outcome).	through study completion, an average of 3 months
Secondary	Shame subscale of the State Shame and Guilt Scale	It will be used to test state shame. Possible scores are ranged from 5 to 25. Higher scores indicate worse state shame.	through study completion, an average of 3 months