Testing a Brief and Low Intensity Self-compassion Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Body Image Disturbance; Body Image; Shame
• Intervention / Treatment: Behavioral: Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice; Behavioral: Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise.; Behavioral: Distraction group

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom, S1 2LT
    • Fidan Turk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Only Active components; 15 minutes, once	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)
Sham Comparator: Inactive components; 15 minutes, once	Behavioral: 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)
Placebo Comparator: Distraction group; 15 minutes, once	Behavioral: Distraction group; Participants will be asked to listen recording on irrelevant topic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Sheffield

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): September 16, 2021
• Study Completion (Actual): September 18, 2021

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 040360

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No