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

Primary Purpose

Visible Difference, Acceptance and Commitment Therapy, ACT

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acceptance-based self-help intervention
Sponsored by
University of Sheffield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visible Difference

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Sheffield

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acceptance-based self-help

Waitlist control group

Arm Description

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

Participants in this group will be placed onto a waitlist for the four-week intervention period.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Work and Social Adjustment Scale (WSAS)
Can be used to measure quality of life and functioning impairments in day-to-day life.

Full Information

First Posted
June 26, 2017
Last Updated
June 18, 2018
Sponsor
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT03205839
Brief Title
Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety
Official Title
Effectiveness of Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety: a Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
November 18, 2017 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sheffield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visible Difference, Acceptance and Commitment Therapy, ACT, Skin Condition, Hair Condition, Craniofacial, Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Entire study completed online, including randomisation.
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance-based self-help
Arm Type
Experimental
Arm Description
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
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
Participants in this group will be placed onto a waitlist for the four-week intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-based self-help intervention
Other Intervention Name(s)
Surviving to Thriving: ACT self-help for living well with...
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comprehensive assessment of Acceptance and Commitment Therapy processes
Description
A general measure of psychological flexibility (and constituent sub-processes) as conceptualized within the ACT model.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Brief Fear of Negative Evaluation Scale II (BFNE-II)
Description
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.
Time Frame
Four weeks
Title
Work and Social Adjustment Scale (WSAS)
Description
Can be used to measure quality of life and functioning impairments in day-to-day life.
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Sheffield
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
No current plan, as data this is the first study in the area.

Learn more about this trial

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

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