Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03004027
Study type Interventional
Source University of Sheffield
Contact
Status Completed
Phase N/A
Start date January 2017
Completion date May 2017

See also
  Status Clinical Trial Phase
Completed NCT05168020 - Evaluation of a Self-Monitoring Intervention to Reduce Safety Behavior in Social Anxiety N/A
Not yet recruiting NCT06020170 - Delving Into Participation Patterns in Social Anxiety Studies
Completed NCT03297619 - Self-help Books for Social Anxiety N/A
Completed NCT04509531 - Building Resilience in Cyberbullying Victims N/A
Recruiting NCT04859790 - Acceptability/Feasibility Testing of SCAR N/A
Completed NCT05576259 - oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder N/A
Completed NCT05858294 - The Safety, Acceptability and Efficacy of Alena N/A
Completed NCT04450303 - Social Anxiety Telehealth Therapy Study N/A
Completed NCT03601377 - Attention Bias Modification Treatment in Social Anxiety N/A
Completed NCT03671577 - Building Closer Friendships in Social Anxiety Disorder N/A
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Recruiting NCT05554718 - Evaluation of a Smartphone Application for Self-help for Social Anxiety N/A
Completed NCT02534948 - Feasibility Study of Mindfulness and Acceptance Based Group Therapy for Social Anxiety N/A
Completed NCT03249116 - Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions N/A
Completed NCT05159037 - Using the Musical Track From GC-MRT as a Treatment Booster in Stressful Situations N/A
Completed NCT03711513 - Facing Fears by Focussing on Behaviour, Body, or Mind? N/A
Completed NCT04845100 - Animal Assisted Activities on the Stress and Social Anxiety N/A
Active, not recruiting NCT04276363 - Families, Children and Teachers Thriving Together N/A
Completed NCT05372744 - Affect-regulatory Characteristics of Deceptive Placebos N/A
Recruiting NCT05798078 - The Relationship Between Social Anxiety and Anxious Thinking Styles N/A