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OpenTrials
Completed

NCT Number: NCT03004027

Enhancing Psychological Self-help With Implementation Intentions

Individuals with visible conditions often report experiencing lowered social confidence and encountering intrusive reactions from others, yet relatively few targeted psychosocial self help interventions are available.

The investigators will conduct a randomised controlled trial to compare the efficacy of an adapted form of an existing self-help intervention with an enhanced version of the same intervention that incorporates if-then planning instructions (or 'implementation intentions') and a control condition that will receive support as usual. Participants who self-identify as having a visible condition affecting the skin or hair, or scarring to the skin that negatively affects their social confidence will be allocated to one of three conditions: augmented self-help, standard self help or control. The interventions will be delivered online and participants will complete psychometric outcome measures at two time points, four weeks apart.

It is hypothesised that participants who receive the augmented self help intervention will have a statistically significant decrease in fear of negative evaluation in comparison to both the standard self-help and support as usual control groups.

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Key information

Conditions

Social Anxiety Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sheffield

Sheffield, South Yorkshire, S1 2LT, United Kingdom

About this study

The proposed research will take the form of a randomised controlled trial conducted in accordance with CONSORT guidelines (http://www.consort-statement.org). Data will be collected online using Qualtrics. Participants will be required to answer all fields on Qualtrics, as a way of managing potential missing data.

Participants will be randomly allocated to one of three groups: (i) psychological self-help augmented with implementation intentions, (ii) standard psychological self-help or (iii) a no intervention waiting list control. Qualtrics will be used to randomly allocate participants to one of the three groups.

A sample size analysis has been conducted and calculated assuming two measures, three groups, an alpha of 0.05, a power of 0.8, and an effect size of 0.25; a total sample size of 120 participants would be needed (i.e. 40 per group). Allowing for an attrition rate of 20%, 144 participants would need to be recruited (i.e. 48 per group). Although participants will be randomised to condition, it is best practice for any differences at baseline to be controlled for in analyses and thus a between factors repeated measure analysis of variance (ANOVA) will be conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants self-identify as having a visible skin difference
  • Participants will be aged 18 years or over
  • Participants will be fluent in the English language

Exclusion criteria

Participants will be excluded if they are currently receiving psychotherapy

Treatment and study plan

Self help leaflet

Other

Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'

Primary outcomes

  1. Change in Brief Fear of Negative Evaluation-II at four weeks (Carleton, Collimore, & Asmundson, 2007)

    Time frame: At baseline and four weeks

Secondary outcomes

  1. Change in Generalised Anxiety Disorder 7 at four weeks

    Time frame: At baseline and four weeks

Other outcomes

  1. Change in Patient Health Questionnaire 9 at four weeks

    Time frame: At baseline and four weeks

Sponsors and collaborators

Lead sponsor

University of Sheffield

Other

Registry information

Official study title

Enhancing Psychological Self-help With Implementation Intentions for Those With Visible Skin Difference and Fear of Negative Evaluation

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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