Body Image DisturbanceNCT04984252
Testing a Brief and Low Intensity Self-compassion Intervention
A study testing Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice, Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise. and Distraction group in people with Body Image Disturbance and Body Image, run by University of Sheffield at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image Disturbance, Body Image, Shame
- What is being tested?
- Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice, Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise. and Distraction group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2021to 18 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Self-identified women
- Be able to use a computer and have an Internet connection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Body Image Disturbance, Body Image, Shame
- Being tested
- Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice, Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise., Distraction group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practiceBehavioural
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.Behavioural
This intervention includes 3 short meditations that are identified as the inactive component in the previous study (ID: NCT04665167)
Distraction groupBehavioural
Participants will be asked to listen recording on irrelevant topic.
| Study group | Role | What they receive |
|---|---|---|
| Only Active components | Active comparator | 15 minutes, once Receives: Behavioral: Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice |
| Inactive components | Sham comparator | 15 minutes, once Receives: Behavioral: Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise. |
| Distraction group | Placebo comparator | 15 minutes, once Receives: Behavioral: Distraction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 3 months
Secondary outcomes (2)
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).
Measured: 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.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Aug 2021
- Primary completion16 Sep 2021
- Study completion18 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Image DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fidan Turk, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984252
- Sponsor's protocol ID
- 040360
- Status last verified
- Sep 2021
- First submitted
- 8 Jul 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Brief and Low Intensity Self-compassion Intervention for State Body Shame Among Adult Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04984252
- Acronym / sponsor ID
- 040360
- Conditions
- Body Image Disturbance, Body Image, Shame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Only Active components | Active comparator | Behavioral: Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice15 minutes, once |
| Inactive components | Sham comparator | Behavioral: Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise.15 minutes, once |
| Distraction group | Placebo comparator | Behavioral: Distraction group15 minutes, once |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Self-identified women
- Be able to use a computer and have an Internet connection
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practiceThis intervention includes 3 short meditations that are identified as the active component in the previous study (ID: NCT04665167) | Behavioural | Only Active components |
| 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) | Behavioural | Inactive components |
| Distraction groupParticipants will be asked to listen recording on irrelevant topic. | Behavioural | Distraction group |
Primary outcome
Change from baseline Subjective units of shame (SUS) at the end of the intervention
Time frame: through study completion, an average of 3 months
Subjective units of shame (SUS), taken at four points during the intervention (scored 0 no shame to 100 full of shame)
2 secondary outcomes
Body Image States Scale
Time frame: through study completion, an average of 3 months
Shame subscale of the State Shame and Guilt Scale
Time frame: through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice, Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise. and Distraction group in people with Body Image Disturbance and Body Image, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Subjective units of shame (SUS) at the end of the intervention (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.