Visible DifferenceNCT03205839
Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety
A study testing Acceptance-based self-help intervention in people with Visible Difference and Acceptance and Commitment Therapy, run by University of Sheffield at 1 site in United Kingdom.
Trial summary
The acceptance and commitment therapy (ACT) model theoretically fits with treating appearance-related anxiety in individuals with a visible difference. This study examines the effectiveness of an acceptance-based self-help manual for this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visible Difference, Acceptance and Commitment Therapy, ACT
- What is being tested?
- Acceptance-based self-help intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jul 2017to 1 Jun 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who self-identify as having a visible difference to their appearance (such as, but not restricted to: hair and skin conditions, burns, craniofacial conditions, birthmarks, surgical scarring)
- Must self-define as experiencing concerns about social interaction or a loss of social confidence in relation to their visible difference.
- Must be aged 18 years or over
- Must be fluent in English language
- Must have access to a computer and the internet
Who cannot join
- Currently receiving any form of psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety: a Pilot Randomised Controlled Trial
The acceptance and commitment therapy (ACT) model theoretically fits with treating appearance-related anxiety in individuals with a visible difference. This study examines the effectiveness of an acceptance-based self-help manual for this population.
Read the detailed description
Individuals with visible difference commonly experience social anxiety due to appearance-related concerns. There are limited resources to help people with appearance-related distress, so internet-provided self-help interventions may be beneficial. A pilot randomised controlled trial will compare the effectiveness of an acceptance-based self-help intervention to a waitlist control group.
We hypothesise (1) the acceptance-based self-help intervention will significantly increase participants' "psychological flexibility", (2) significantly decrease fear of negative evaluation from others and (3) significantly increase their quality of life, compared to the waitlist control group. Data will be collected at two time points only.
General distress (CORE-10) will be collected pre-intervention only to ensure randomisation has been successful. Should the two groups significantly differ in distress, this will be accounted for in subsequent analyses.
- Conditions
- Visible Difference, Acceptance and Commitment Therapy, ACT, Skin Condition, Hair Condition, Craniofacial
- Being tested
- Acceptance-based self-help intervention
- Medical subject headings
- Skin Diseases, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-based self-help interventionBehavioural
Also called Surviving to Thriving: ACT self-help for living well with...
Surviving to Thriving: ACT self-help for living well with a visible difference in appearance.
A self-help booklet, based upon Acceptance and Commitment Therapy (ACT). The booklet includes some ACT techniques and encourages participants to set themselves behavioural tasks, based upon their values. There is a suggested timetable for participants to navigate through the self-help during the four-week intervention period.
In addition to the pdf booklet, there are accompanying audio exercises and a lived experience video.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance-based self-help | Experimental | Participants in this group will receive the self-help booklet.
Surviving to Thriving: ACT self-help for living well with a visible difference in appearance Receives: Behavioral: Acceptance-based self-help intervention |
| Waitlist control group | No intervention | Participants in this group will be placed onto a waitlist for the four-week intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive assessment of Acceptance and Commitment Therapy processes
A general measure of psychological flexibility (and constituent sub-processes) as conceptualized within the ACT model.
Measured: Four weeks
Secondary outcomes (2)
Brief Fear of Negative Evaluation Scale II (BFNE-II)
The BFNE-II is a 12-item revised version of the Brief Fear of Negative Evaluation scale (BFNE; Leary, 1983) used for measuring fears of negative evaluation (e.g., ''I am afraid that others will not approve of me''). Items are rated on a 5-point Likert scale ranging from 0 (not at all characteristic of me) to 4 (extremely characteristic of me). This correlates highly with measures of social anxiety.
Measured: Four weeks
Work and Social Adjustment Scale (WSAS)
Can be used to measure quality of life and functioning impairments in day-to-day life.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start27 Jul 2017
- Primary completion18 Nov 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visible DifferenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luke Powell, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205839
- Sponsor's protocol ID
- 151066
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2017
- Last updated
- 19 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No current plan, as data this is the first study in the area.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03205839
- Acronym / sponsor ID
- 151066
- Conditions
- Visible Difference, Acceptance and Commitment Therapy, ACT, Skin Condition, Hair Condition, Craniofacial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 18 Nov 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 2 Jul 2017 (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 acceptance and commitment therapy (ACT) model theoretically fits with treating appearance-related anxiety in individuals with a visible difference. This study examines the effectiveness of an acceptance-based self-help manual for this population.
Detailed description
Individuals with visible difference commonly experience social anxiety due to appearance-related concerns. There are limited resources to help people with appearance-related distress, so internet-provided self-help interventions may be beneficial. A pilot randomised controlled trial will compare the effectiveness of an acceptance-based self-help intervention to a waitlist control group.
We hypothesise (1) the acceptance-based self-help intervention will significantly increase participants' "psychological flexibility", (2) significantly decrease fear of negative evaluation from others and (3) significantly increase their quality of life, compared to the waitlist control group. Data will be collected at two time points only.
General distress (CORE-10) will be collected pre-intervention only to ensure randomisation has been successful. Should the two groups significantly differ in distress, this will be accounted for in subsequent analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance-based self-help | Experimental | Behavioral: Acceptance-based self-help interventionParticipants in this group will receive the self-help booklet. Surviving to Thriving: ACT self-help for living well with a visible difference in appearance |
| Waitlist control group | No intervention | –Participants in this group will be placed onto a waitlist for the four-week intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals who self-identify as having a visible difference to their appearance (such as, but not restricted to: hair and skin conditions, burns, craniofacial conditions, birthmarks, surgical scarring)
- Must self-define as experiencing concerns about social interaction or a loss of social confidence in relation to their visible difference.
- Must be aged 18 years or over
- Must be fluent in English language
- Must have access to a computer and the internet
Key exclusion criteria (1 listed)
- Currently receiving any form of psychotherapy
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 |
|---|---|---|
| Acceptance-based self-help interventionAlso: Surviving to Thriving: ACT self-help for living well with...Surviving to Thriving: ACT self-help for living well with a visible difference in appearance. A self-help booklet, based upon Acceptance and Commitment Therapy (ACT). The booklet includes some ACT techniques and encourages participants to set themselves behavioural tasks, based upon their values. There is a suggested timetable for participants to navigate through the self-help during the four-week intervention period. In addition to the pdf booklet, there are accompanying audio exercises and a lived experience video. | Behavioural | Acceptance-based self-help |
Primary outcome
Comprehensive assessment of Acceptance and Commitment Therapy processes
Time frame: Four weeks
A general measure of psychological flexibility (and constituent sub-processes) as conceptualized within the ACT model.
2 secondary outcomes
Brief Fear of Negative Evaluation Scale II (BFNE-II)
Time frame: Four weeks
Work and Social Adjustment Scale (WSAS)
Time frame: Four weeks
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 19 Jun 2018.
- Individual participant dataSharing planned: Undecided. No current plan, as data this is the first study in the area.
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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 Acceptance-based self-help intervention in people with Visible Difference and Acceptance and Commitment Therapy, 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 5 inclusion and 1 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 19 Jun 2018. 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. 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?
Comprehensive assessment of Acceptance and Commitment Therapy processes (time frame: Four weeks). 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 19 Jun 2018.