Clinical trial NCT03004027: Enhancing Psychological Self-help With Implementation Intentions
Official title: Enhancing Psychological Self-help With Implementation Intentions for Those With Visible Skin Difference and Fear of Negative Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Keywords: health behaviour change
implementation intention
if then plan
skin condition
visible difference
self help
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Brief Fear of Negative Evaluation-II at four weeks (Carleton, Collimore, & Asmundson, 2007)
timeFrame: At baseline and four weeks
Secondary outcomes:
measure: Change in Generalised Anxiety Disorder 7 at four weeks
timeFrame: At baseline and four weeks
Other outcomes:
measure: Change in Patient Health Questionnaire 9 at four weeks
timeFrame: At baseline and four weeks
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Jessica C Lane
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.