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Social Anxiety DisorderNCT03514225

Metacognitive Therapy for Social Anxiety in Youth

A study testing Metacognitive Therapy for Social Anxiety in people with Social Anxiety Disorder and Social Anxiety, run by University of Manchester at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 13 to 17 years
What is being tested?
Metacognitive Therapy for Social Anxiety
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited Kingdom
Study dates
10 Aug 2018to 11 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Manchester University NHS Foundation Trust (MFT)

    Manchester, Greater Manchester, M13 9PL

Other trials in United Kingdom

About this study

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

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.

Read more

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?
Read the detailed 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.

Being tested
Metacognitive Therapy for Social Anxiety
Keywords
Metacognitive Therapy
Medical subject headings
Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metacognitive Therapy for Social AnxietyOther

    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.

Study groups in NCT03514225
Study groupRoleWhat they receive
Metacognitive Therapy for Social AnxietyOtherExact 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.
Receives: Other: Metacognitive Therapy for Social Anxiety

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

  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.

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

  2. Revised Social Phobia Rating Scale (R-SPRS)

    A measure of mechanisms (i.e. metacognitive beliefs) which are the focus of modification in MCT, as well as measuring underlying causal processes, self-focussed attention and safety behaviours.

    Item 1 measures distress caused by SAD over the past week on a scale of 0-8. Item 2 measures avoidance over the past week on a scale of 0-8. Item 3 measures self-consciousness over the past week on a scale of 0-8. Item 4 measures safety behaviours, with each listed safety behaviour rated from 0-8. Item 5 measures socially anxious thinking, with each thought rated from 0-100. Item 6 measures worry and rumination over the past week on a scale of 0-8. Item 7 measures threat-monitoring over the past week on a scale of 0-8. Item 8 measures metacognitive beliefs, with each belief rated on a scale of 0-100.

    This scale does not provide an overall score. Each item will be examined individually for change across time as this is a process measure. Higher scores on items indicate worse outcomes.

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

  3. Revised Social Phobia Rating Scale (R-SPRS)

    A measure of mechanisms (i.e. metacognitive beliefs) which are the focus of modification in MCT, as well as measuring underlying causal processes, self-focussed attention and safety behaviours.

    Item 1 measures distress caused by SAD over the past week on a scale of 0-8. Item 2 measures avoidance over the past week on a scale of 0-8. Item 3 measures self-consciousness over the past week on a scale of 0-8. Item 4 measures safety behaviours, with each listed safety behaviour rated from 0-8. Item 5 measures socially anxious thinking, with each thought rated from 0-100. Item 6 measures worry and rumination over the past week on a scale of 0-8. Item 7 measures threat-monitoring over the past week on a scale of 0-8. Item 8 measures metacognitive beliefs, with each belief rated on a scale of 0-100.

    This scale does not provide an overall score. Each item will be examined individually for change across time as this is a process measure. Higher scores on items indicate worse outcomes.

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

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

    A 47-item screening measure designed to assess selected anxiety and depressive disorders (including SAD).

    Subscales assess:

    Social phobia (9 items; maximum score = 27). Panic disorder (9 items; maximum score = 27). Separation anxiety (7 items; maximum score = 21). Generalised anxiety (6 items; maximum score = 18). Obsessive-compulsive (6 items; maximum score = 18). Major depression (10 items; maximum score = 30).

    In response to each item, participants must select the appropriate response from 'Always' (score = 3), 'Often' (score = 2), 'Sometimes' (score = 1), 'Never' (score = 0).

    Total minimum score = 0. Total maximum score = 141. Higher scores indicate worse outcomes.

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

  5. Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001)

    A 25-item screening questionnaire comprising of 5 scales of 5 items each assessing prosocial behaviour and emotional, conduct, peer relationship and hyperactivity/inattention difficulties.

    Total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0-40. Higher scores indicate worse outcomes.

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

  6. Session Feedback Questionnaire (SFQ; Evidence Based Practice Unit, 2012)

    Assesses aspects including whether participants felt listened to and understood session content.

    Measured: Intervention session 1 (4-6 weeks after 1st baseline measure, dependent on length of baseline), session 4 (7-10 weeks after 1st baseline measure) and session 8 (11-14 weeks after 1st baseline measure).

  7. Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)

    A 6-item self-report measure assessing participant expectancies

    Measured: Intervention session 2 (4-7 weeks after 1st baseline measure, dependent on length of baseline)

  8. Proportion of missed appointments (DNAs)

    Categorised as when a participant misses an appointment without advance notice

    Measured: Proportion of DNAs to be calculated at the end of the intervention phase (11-14 weeks after 1st baseline measure, depending on length of baseline)

  9. Treatment completion

    Completion = when a participant attends all 8 MCT sessions

    Measured: Proportions to be calculated at the end of the intervention phase of the study (11-14 weeks after 1st baseline measure, depending on length of baseline)

  10. Drop-out rates

    Drop out = when a participant terminates the intervention prior to receiving all 8 sessions

    Measured: Proportions to be calculated at the end of the intervention phase (11-14 weeks after 1st baseline measure, depending on length of baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2018
  2. Study start10 Aug 2018
  3. Primary completion9 Apr 2019
  4. Study completion11 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03514225
Sponsor's protocol ID
238314
Status last verified
Apr 2019
First submitted
19 Mar 2018
Last updated
19 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available

Publications

  • 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

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

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

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

  • 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.

    PubMed 8990539

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

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

  • 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

  • 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.

    PubMed 10937431

  • 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.

    PubMed 11699809

  • 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.

    PubMed 11132119

Questions about this trial

What is this clinical trial studying?

A study testing Metacognitive Therapy for Social Anxiety in people with Social Anxiety Disorder and Social Anxiety, run by University of Manchester at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Phobia and Anxiety Inventory for Children (SPAI-C; Beidel et al., 1995) (time frame: Change in overall SPAI-C score from baseline to 8 weeks post-baseline (end of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03514225, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.

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