Metacognitive Therapy for Social Anxiety in Youth

NCT03514225 | Completed

• 1 other identifier: 238314
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Social Anxiety Disorder; Social Anxiety; Social Phobia

Keywords

Metacognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Social Phobia and Anxiety Inventory for Children (SPAI-C; Beidel et al., 1995)

  A 26-item measure of social anxiety, assessing assertiveness, general conversation, physical and cognitive symptoms, avoidance and public performance.

  Change in overall SPAI-C score from baseline to 8 weeks post-baseline (end of intervention)

Secondary Outcomes (10)

• Social Phobia and Anxiety Inventory for Children (SPAI-C; Beidel et al., 1995)

  Change in overall SPAI-C score from baseline to 1 month follow-up

• Revised Social Phobia Rating Scale (R-SPRS)

  Change in R-SPRS scores from baseline to approximately 8 weeks post-baseline (end of intervention)

• Revised Social Phobia Rating Scale (R-SPRS)

  Change in R-SPRS scores from baseline to 1 month follow-up

• Revised Children's Anxiety and Depression Scale (RCADS; Chorpita et al.,2000)

  Weekly during baseline, once approximately 8 weeks post-baseline (end of the intervention), and once at 1 month follow-up

• Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001)

  Weekly during baseline, once approximately 8 weeks post-baseline (end of the intervention), and once at 1 month follow-up

Study Arms (1)

Metacognitive Therapy for Social Anxiety

OTHER

Exact sessional content of the MCT intervention is likely to involve attention training and situational attentional refocussing techniques, verbal reattribution strategies aimed to facilitate a reduction of self-processing strategies and to challenge metacognitive beliefs, and between-session tasks for participants to practice at home.

Other: Metacognitive Therapy for Social Anxiety

Interventions

Metacognitive Therapy for Social Anxiety OTHER

The transdiagnostic Metacognitive model posits that psychological disorder stems from the activation of a perseverative thinking style called the CAS (Cognitive Attentional Syndrome). This has 3 key elements: worry/rumination, threat-focussed attention and unhelpful coping behaviours. Each of these elements results in extended cognitive responses to negative thoughts, prolonging negative emotions and maintaining an individual's sense of threat. The CAS arises from an individual's positive and negative metacognitive beliefs (beliefs about cognition). Metacognitive Therapy (MCT) aims to bring the CAS under control by modifying metacognitive beliefs and enabling individuals to develop new reactions to negative thoughts.

Metacognitive Therapy for Social Anxiety

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must meet criteria for SAD on the ADIS-IV
• Participants must be aged between 13-17 years old at the time of consent
• SAD must be their primary presenting problem (generalised or specific subtype)
• Participants may or may not be taking medication for a mental health difficulty as long as this remains stable during the study
• Participants may or may not have received previous psychological intervention for SAD as long as this is not ongoing

You may not qualify if:

• They are aged 18 or above or under the age of 13 at the time of consent
• SAD is not their primary presenting problem
• They are currently undergoing other forms of psychological intervention for SAD or other mental health difficulties \[other interventions would need to be suspended for the duration of the study\]
• They have a diagnosis of autism spectrum disorder, attention deficit hyperactivity disorder or a learning disability which would impair their ability to participate
• They are non-English speaking
• They are currently demonstrating a high level of risk to themselves or others
• Although participants may also experience low mood, this must not be severe enough to warrant treatment in its own right

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust (MFT)

Manchester, Greater Manchester, M13 9PL, United Kingdom

Location

Related Publications (11)

• Beidel, D. C., Turner, S. M. & Fink, C. M. (1996). Assessment of Childhood Social Phobia: Construct, Convergent, and Discriminative Validity of the Social Phobia and Anxiety Inventory for Children (SPAI-C). Psychological Assessment, 8(3), 235-240

  BACKGROUND

• Wells, A. (2009). Metacognitive Therapy for Anxiety and Depression. New York: Guilford Press

  BACKGROUND

• Evidence Based Practice Unit (2012). Session Feedback Questionnaire. Retrieved from www.corc.uk.net, 22 September 2017

  BACKGROUND

• Wells, A., & Matthews, G. (1994). Attention and Emotion: A clinical perspective. Hove UK: Erlbaum.

  BACKGROUND

• Wells A, Matthews G. Modelling cognition in emotional disorder: the S-REF model. Behav Res Ther. 1996 Nov-Dec;34(11-12):881-8. doi: 10.1016/s0005-7967(96)00050-2.

  PMID: 8990539 BACKGROUND

• Wells, A. (1997). Cognitive Therapy of Anxiety Disorders: A Practice Manual and Conceptual Guide. John Wiley & Sons Ltd.

  BACKGROUND

• Nordahl, H. & Wells, A. (2017). Metacognitive Therapy for Social Anxiety Disorder. Manuscript submitted for publication

  BACKGROUND

• Silverman, W. K. & Albano, A. M. (1996). The Anxiety Disorders Interview Schedule for Children for DSM-IV: Clinician Manual (Child and Parent Versions). Psychological Corporation, San Antonio, TX

  BACKGROUND

• Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.

  PMID: 10937431 BACKGROUND

• Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.

  PMID: 11699809 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Adrian Wells

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical and Experimental Psychopathology

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: May 2, 2018
• Study Start: August 10, 2018
• Primary Completion: April 9, 2019
• Study Completion: April 11, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available within 12 months of study completion
• Access Criteria: Anonymised data will be made available on request (to the Principle Investigator) after publication.

Locations

GB (1)