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Completed

NCT Number: NCT03205839

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

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.

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Key information

Conditions

Visible Difference ACT Acceptance and Commitment Therapy Burns Craniofacial Hair Condition Skin Condition Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sheffield

Sheffield, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance-based self-help intervention

Behavioral

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.

Other names: Surviving to Thriving: ACT self-help for living well with...

Primary outcomes

  1. 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.

Secondary outcomes

  1. Brief Fear of Negative Evaluation Scale II (BFNE-II)

    Time frame: Four weeks

    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.

  2. Work and Social Adjustment Scale (WSAS)

    Time frame: Four weeks

    Can be used to measure quality of life and functioning impairments in day-to-day life.

Sponsors and collaborators

Lead sponsor

University of Sheffield

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 2, 2017
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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