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

Not Applicable

Completed

• Conditions: Acceptance and Commitment Therapy; Skin Condition; ACT; Hair Condition; Craniofacial; Burns; Visible Difference
• Interventions: Behavioral: Acceptance-based self-help intervention

• Registration Number: NCT03205839
• Lead Sponsor: University of Sheffield

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.

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2017-07-27
• Primary Completion: 2017-11-18
• Status Verified: 2018-06
• Study Completion: 2018-06-01
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance-based self-help	Acceptance-based self-help intervention	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

Primary Outcome Measures

Name	Time	Method
Comprehensive assessment of Acceptance and Commitment Therapy processes	Four weeks	A general measure of psychological flexibility (and constituent sub-processes) as conceptualized within the ACT model.

Secondary Outcome Measures

Name	Time	Method
Work and Social Adjustment Scale (WSAS)	Four weeks	Can be used to measure quality of life and functioning impairments in day-to-day life.
Brief Fear of Negative Evaluation Scale II (BFNE-II)	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.

Trial Locations

Locations (1)

University of Sheffield; 🇬🇧 Sheffield, United Kingdom