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Clinical Trials/NCT03205839
NCT03205839
Completed
Not Applicable

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

University of Sheffield1 site in 1 country284 target enrollmentJuly 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Visible Difference
Sponsor
University of Sheffield
Enrollment
284
Locations
1
Primary Endpoint
Comprehensive assessment of Acceptance and Commitment Therapy processes
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 27, 2017
End Date
June 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luke Powell

Trainee Clinical Psychologist

University of Sheffield

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Work and Social Adjustment Scale (WSAS)(Four weeks)
  • Brief Fear of Negative Evaluation Scale II (BFNE-II)(Four weeks)

Study Sites (1)

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