Enhancing Psychological Self-help With Implementation Intentions

NCT03004027 | Completed

• 1 other identifier: 147400
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety

Keywords

health behaviour change; implementation intention; if then plan; skin condition; visible difference; self help

Outcome Measures

Primary Outcomes (1)

• Change in Brief Fear of Negative Evaluation-II at four weeks (Carleton, Collimore, & Asmundson, 2007)

  At baseline and four weeks

Secondary Outcomes (1)

• Change in Generalised Anxiety Disorder 7 at four weeks

  At baseline and four weeks

Other Outcomes (1)

• Change in Patient Health Questionnaire 9 at four weeks

  At baseline and four weeks

Study Arms (3)

Enhanced

EXPERIMENTAL

self help leaflet enhanced with implementation intentions

Other: Self help leaflet

Standard

ACTIVE COMPARATOR

self help leaflet standard (without implementation intentions)

Other: Self help leaflet

Waiting list control

NO INTERVENTION

Baseline measures administered only. self help intervention will be made available once the study has finished.

Interventions

Self help leaflet OTHER

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

Enhanced; Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants will be excluded if they are currently receiving psychotherapy

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

University of Sheffield

Sheffield, South Yorkshire, S1 2LT, United Kingdom

Location

Related 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. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Jessica C Lane

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: December 17, 2016
• First Posted: December 28, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

GB (1)