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
1 other identifier
interventional
284
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedStudy Start
First participant enrolled
July 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 19, 2018
June 1, 2018
4 months
June 26, 2017
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Brief Fear of Negative Evaluation Scale II (BFNE-II)
Four weeks
Work and Social Adjustment Scale (WSAS)
Four weeks
Study Arms (2)
Acceptance-based self-help
EXPERIMENTALParticipants in this group will receive the self-help booklet. Surviving to Thriving: ACT self-help for living well with a visible difference in appearance
Waitlist control group
NO INTERVENTIONParticipants in this group will be placed onto a waitlist for the four-week intervention period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently receiving any form of psychotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sheffield
Sheffield, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Entire study completed online, including randomisation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Trainee Clinical Psychologist
Study Record Dates
First Submitted
June 26, 2017
First Posted
July 2, 2017
Study Start
July 27, 2017
Primary Completion
November 18, 2017
Study Completion
June 1, 2018
Last Updated
June 19, 2018
Record last verified: 2018-06