NCT03205839

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

July 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

June 26, 2017

Last Update Submit

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

EXPERIMENTAL

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

Waitlist control group

NO INTERVENTION

Participants 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.

Also known as: Surviving to Thriving: ACT self-help for living well with...
Acceptance-based self-help

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Skin DiseasesBurns

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesWounds and Injuries

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

Locations