Metacognitive Therapy for Social Anxiety in Youth

Social Anxiety Disorder Clinical Trial

Official title: Metacognitive Therapy for Social Anxiety in Youth: A Systematic Replication Series

Status Completed

Clinical Trial Summary

Social anxiety disorder (SAD) is a fear of social situations that involve interacting with other people. Although it can be very upsetting, there are ways to help people deal with it. This study aims to explore the use of a new treatment called Metacognitive Therapy (MCT) for social anxiety in children and teenagers. MCT is a one-to-one talking therapy which works by changing people's patterns of attention and thinking in social situations. By doing this, people with SAD can begin to feel more confident and less anxious when interacting with others.

Findings suggests that MCT works well when treating adults who have social anxiety. However, this treatment has not yet been used with young people. This study hopes to explore whether MCT can help treat SAD in children and teenagers. This information will help us to plan larger studies in the future.

People who would like to take part in this study will be asked to fill in some questionnaires once a week for at least 2 weeks and return these to the researcher in the post. Following this, they will be offered 8 weekly sessions of MCT at their local Child and Adolescent Mental Health Service. Each session will last for about 1 hour. This will involve talking to a clinician about how they think and feel when in social situations, and filling in some more questionnaires. This will allow us to see how their social anxiety changes week-by-week and whether this has improved by the end of treatment (week 8).

1-months after people have had their last session of MCT, they will be asked to complete and return a final set of questionnaires through the post. This will allow us to get a final measure of their social anxiety and see whether any changes in SAD have been maintained.

Primary Questions:

• Is MCT a feasible and acceptable treatment for social anxiety disorder within a child and adolescent population?

• Is MCT associated with improvements in SAD symptoms and functioning?

Secondary Questions:

• Are benefits associated with MCT replicable across subtypes of social anxiety disorder (general and specific)?

• Are any gains associated with MCT for social anxiety disorder maintained at 1 month follow up?

Clinical Trial Description

A systematic case replication series utilising an A-B design with 1-month follow-up will be used within this study to replicate MCT intervention across SAD subtypes. (A = no treatment baseline; B = 8 weekly one-one sessions of MCT). This design was chosen as MCT is a relatively novel approach to SAD, particularly within a child and adolescent population.

Recruitment:

Potential participants will be identified by CAMHS Clinicians during routine clinical practice. If the Anxiety Disorders Interview Schedule-IV Child/Parent Version indicates clinical severity of SAD, individuals will be invited to participate in the full study.

This study aims to recruit 5 participants experiencing social anxiety disorder. Participants who drop out of the study during the baseline phase (i.e. before receiving any sessions of MCT intervention) will be replaced by another eligible participant who will be recruited in their place. However, any participants who drop out during the intervention phase of the study will not be replaced.

Phase 1 (Baseline):

During the initial phase of the study, participants will be asked to complete baseline measures once a week for a minimum of 2 weeks (with at least 3 data-points) until stability of scores is achieved. Stability of scores will be defined as 3 consecutive data points showing an increasing or horizontal trend on the primary outcome measure. If the last data point is decreasing, baseline will be extended until stable trends can be plotted, although if stability of scores is not achieved by 6 weeks (i.e. 6 data points) then intervention will be introduced at this point regardless.

Phase 2 (Intervention):

Participants will be invited to attend 8 weekly sessions of MCT at their local CAMHS. Each session will last approximately 1 hour. Participants will be asked to complete sessional measures to allow for monitoring of SAD symptoms and metacognitive beliefs, as well as measures of treatment acceptability.

Phase 3 (Follow-up):

Follow-up will be conducted between 4-6 weeks after the final treatment session. Participants will be asked to complete and return a final set of measures via the post. This will provide a final measure of SAD symptoms and metacognitions and see whether any benefits of receiving MCT have been maintained.

Phase 4 (Exit Interviews):

Participants will be invited to complete an optional, semi-structured exit interview to gather descriptive level information regarding how they found the intervention. This will examine factors such as which components of the intervention were well received. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety
• Social Anxiety Disorder
• Social Phobia

• NCT number: NCT03514225
• Study type: Interventional
• Source: University of Manchester
• Status: Completed
• Phase: N/A
• Start date: August 10, 2018
• Completion date: April 11, 2019