Enhancing Psychological Self-help With Implementation Intentions
NCT ID: NCT03004027
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
326 participants
INTERVENTIONAL
2017-01-31
2017-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enhanced
self help leaflet enhanced with implementation intentions
Self help leaflet
Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'
Standard
self help leaflet standard (without implementation intentions)
Self help leaflet
Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'
Waiting list control
Baseline measures administered only. self help intervention will be made available once the study has finished.
No interventions assigned to this group
Interventions
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Self help leaflet
Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'
Eligibility Criteria
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Inclusion Criteria
* Participants will be aged 18 years or over
* Participants will be fluent in the English language
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Sheffield
OTHER
Responsible Party
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Jessica Lane
Trainee Clinical Psychologist
Principal Investigators
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Jessica C Lane
Role: PRINCIPAL_INVESTIGATOR
University of Sheffield
Locations
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University of Sheffield
Sheffield, South Yorkshire, United Kingdom
Countries
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References
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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. doi: 10.3758/bf03193146.
Other Identifiers
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147400
Identifier Type: -
Identifier Source: org_study_id