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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205839
• Other study ID #: 151066
• Status: Completed
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: University of Sheffield
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: June 1, 2018
• Est. primary completion date: November 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy
• ACT
• Burns
• Craniofacial
• Disease
• Hair Condition
• Skin Condition
• Skin Diseases
• Visible Difference

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Sheffield	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Work and Social Adjustment Scale (WSAS)	Can be used to measure quality of life and functioning impairments in day-to-day life.	Four weeks