Enhancing Psychological Self-help With Implementation Intentions

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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety
• Intervention / Treatment: Other: Self help leaflet

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.

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S1 2LT
      • University of Sheffield

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced; self help leaflet enhanced with implementation intentions	Other: Self help leaflet; Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'
Active Comparator: Standard; self help leaflet standard (without implementation intentions)	Other: Self help leaflet; Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'
No Intervention: Waiting list control; Baseline measures administered only. self help intervention will be made available once the study has finished.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Brief Fear of Negative Evaluation-II at four weeks (Carleton, Collimore, & Asmundson, 2007)	At baseline and four weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Generalised Anxiety Disorder 7 at four weeks	At baseline and four weeks

Other Outcome Measures

Outcome Measure	Time Frame
Change in Patient Health Questionnaire 9 at four weeks	At baseline and four weeks

Collaborators and Investigators

• Sponsor: University of Sheffield
• Investigators: Principal Investigator: Jessica C Lane, University of Sheffield

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: December 17, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: implementation intention; skin condition; health behaviour change; if then plan; visible difference; self help
• Other Study ID Numbers: 147400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Possibility that data will be used in future research. Individual participant data includes age, gender, description of visible skin difference and scores on the Brief Fear of Negative Evaluation, General Anxiety Disorder 7, Patient Health Questionnaire 9 questionnaires. Data will be obtained with agreement from the primary investigator Jessica Lane (jlane1@sheffield.ac.uk)