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

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.

Study Overview

• Status: Completed
• Conditions: Burns; Skin Condition; Visible Difference; Acceptance and Commitment Therapy; ACT; Hair Condition; Craniofacial
• Intervention / Treatment: Behavioral: Acceptance-based self-help intervention

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 Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Sheffield, United Kingdom
    • University of Sheffield

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance-based self-help; 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	Behavioral: Acceptance-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.; Other Names: Surviving to Thriving: ACT self-help for living well with...
No Intervention: Waitlist control group; Participants in this group will be placed onto a waitlist for the four-week intervention period.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four weeks
Work and Social Adjustment Scale (WSAS)	Can be used to measure quality of life and functioning impairments in day-to-day life.	Four weeks

Collaborators and Investigators

• Sponsor: University of Sheffield

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2017
• Primary Completion (Actual): November 18, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Skin Diseases
• Other Study ID Numbers: 151066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: No current plan, as data this is the first study in the area.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No