Enhancing Psychological Self-help With Implementation Intentions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03004027
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):
Jessica Lane, University of Sheffield

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Other: Self help leaflet Not Applicable

Detailed Description:

The proposed research will take the form of a randomised controlled trial conducted in accordance with CONSORT guidelines ( 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  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Psychological Self-help With Implementation Intentions for Those With Visible Skin Difference and Fear of Negative Evaluation
Actual Study Start Date : January 2017
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.

Primary Outcome Measures :
  1. Change in Brief Fear of Negative Evaluation-II at four weeks (Carleton, Collimore, & Asmundson, 2007) [ Time Frame: At baseline and four weeks ]

Secondary Outcome Measures :
  1. Change in Generalised Anxiety Disorder 7 at four weeks [ Time Frame: At baseline and four weeks ]

Other Outcome Measures:
  1. Change in Patient Health Questionnaire 9 at four weeks [ Time Frame: At baseline and four weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03004027

United Kingdom
University of Sheffield
Sheffield, South Yorkshire, United Kingdom, S1 2LT
Sponsors and Collaborators
University of Sheffield
Principal Investigator: Jessica C Lane University of Sheffield

Responsible Party: Jessica Lane, Trainee Clinical Psychologist, University of Sheffield Identifier: NCT03004027     History of Changes
Other Study ID Numbers: 147400
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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 (

Keywords provided by Jessica Lane, University of Sheffield:
health behaviour change
implementation intention
if then plan
skin condition
visible difference
self help