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Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety

Effectiveness of Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety: a Pilot Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03205839
Enrollment
284
Registered
2017-07-02
Start date
2017-07-27
Completion date
2018-06-01
Last updated
2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acceptance and Commitment Therapy, ACT, Burns, Craniofacial, Hair Condition, Skin Condition, Visible Difference

Brief 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.

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.

Interventions

BEHAVIORALAcceptance-based self-help intervention

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.

Sponsors

University of Sheffield
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Entire study completed online, including randomisation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Currently receiving any form of psychotherapy

Design outcomes

Primary

MeasureTime frameDescription
Comprehensive assessment of Acceptance and Commitment Therapy processesFour weeksA general measure of psychological flexibility (and constituent sub-processes) as conceptualized within the ACT model.

Secondary

MeasureTime frameDescription
Brief Fear of Negative Evaluation Scale II (BFNE-II)Four weeksThe 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.
Work and Social Adjustment Scale (WSAS)Four weeksCan be used to measure quality of life and functioning impairments in day-to-day life.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026