NCT04984252

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2021

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

July 8, 2021

Last Update Submit

September 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Body Image States Scale

    through study completion, an average of 3 months

  • Shame subscale of the State Shame and Guilt Scale

    through study completion, an average of 3 months

Study Arms (3)

Only Active components

ACTIVE COMPARATOR

15 minutes, once

Behavioral: Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice

Inactive components

SHAM COMPARATOR

15 minutes, once

Behavioral: Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise.

Distraction group

PLACEBO COMPARATOR

15 minutes, once

Behavioral: Distraction group

Interventions

This intervention includes 3 short meditations that are identified as the active component in the previous study (ID: NCT04665167)

Only Active components

This intervention includes 3 short meditations that are identified as the inactive component in the previous study (ID: NCT04665167)

Inactive components

Participants will be asked to listen recording on irrelevant topic.

Distraction group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fidan Turk

Sheffield, S1 2LT, United Kingdom

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 30, 2021

Study Start

August 1, 2021

Primary Completion

September 16, 2021

Study Completion

September 18, 2021

Last Updated

October 5, 2021

Record last verified: 2021-09

Locations