Enhancing Psychological Self-help With Implementation Intentions

Social Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004027
• Other study ID #: 147400
• Status: Completed
• Phase: N/A
• First received: December 17, 2016
• Last updated: October 24, 2017
• Start date: January 2017
• Est. completion date: May 2017

Study information

• Verified date: October 2017
• Source: University of Sheffield
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Social Anxiety

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Sheffield	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Patient Health Questionnaire 9 at four weeks		At baseline and four weeks
Primary	Change in Brief Fear of Negative Evaluation-II at four weeks (Carleton, Collimore, & Asmundson, 2007)		At baseline and four weeks
Secondary	Change in Generalised Anxiety Disorder 7 at four weeks		At baseline and four weeks