NCT02550379

Brief Summary

While it has been hypothesised that individuals who experience social anxiety are more likely to misread facial emotions as threatening or disapproving, researchers have proposed that the difficulty may lie in decoding ambiguous facial expressions rather than identifying emotions which are expressed with greater intensity. Emotion recognition (ER) training provides a promising new avenue of research which may be beneficial in altering emotion processing biases which maintain or increase symptoms of mental health disorders. This study will examine the effectiveness of ER training in a community-based sample of young people (15-18 years) who report high levels of social anxiety. The intervention aims to alter emotion processing biases through a training procedure designed to promote the perception of happiness over disgust in ambiguous facial expressions which we hypothesise will subsequently reduce symptoms of social anxiety. The study design consists of two phases. During Phase 1 participants will complete a screening questionnaire. This questionnaire will include a measure of the affective, cognitive, and behavioural components of social anxiety in adolescence. Depending on their suitability (i.e. scoring above a cut-off on a standardised measure of social anxiety in Phase 1 of the study), participants may then be invited to take part in a 4-day computer-based emotion recognition training programme (Phase 2). The purpose of this phase is to see if ER training will help young people feel less worried or nervous in social situations by training them to interpret ambiguous facial expressions as expressing a positive emotion (happy rather than disgusted). Participants will be randomly assigned to either the intervention or placebo (inactive) group. Both groups will be asked to complete a 4-day programme involving one computer training session per day (each session takes approximately 20 minutes). Questionnaires will also be given to participants to complete before and after the intervention, along with a 2-week follow-up assessment. These will include questionnaires to measure social anxiety, depressive symptoms, and fear of negative evaluation. Each questionnaire will take approximately 15 minutes to complete. Participants will not know whether they have received the intervention or placebo training until after the intervention.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable anxiety

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

September 11, 2015

Last Update Submit

November 8, 2016

Conditions

Keywords

Social AnxietySocial PhobiaDepressionEmotion Recognition Training

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in social anxiety at post-intervention

    A 26-item self-report questionnaire to measure social anxiety - Social Phobia and Anxiety Inventory for Children (SPAI-C; Biedel et al., 1998)

    Pre-intervention (day 1), post-intervention (day 4)

Secondary Outcomes (5)

  • Change from baseline in social anxiety at 2-week follow-up

    Pre-intervention (day 1), 2-week follow-up post-intervention

  • Change from baseline in emotion sensitivity measurement at post-intervention and 2-week follow-up

    Pre-intervention (day 1), post-intervention (day 4), 2-week follow-up post-intervention

  • Change from baseline in fear of negative evaluation at post-intervention and 2-week follow-up

    Pre-intervention (day 1), post-intervention (day 4), and 2-week follow-up

  • Change from baseline in anxiety related disorders at post-intervention and 2-week follow-up

    Pre-intervention (day 1), post-intervention (week 4), and 2-week follow-up

  • Change from baseline in depression symptoms at post-intervention and 2-week follow-up

    Pre-intervention (day 1), post-intervention (day 4), and 2-week follow-up

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo protocol consists of 3 phases, baseline, training, and test. The baseline phase consists of 45 trials which calculates the balance point at which the participant rates a face as 'happy' rather than 'disgusted' over a continuum of 15 faces ranging from happy through ambiguous to disgust. 3 training blocks are then administered with 30 trials per block. Behavioural feedback is given during training (correct/incorrect) based on the participant's balance point at baseline. A test phase is then administered which is identical to the baseline phase to reassess the participant's balance point. The task takes approximately 15 minutes to complete all 3 phases.

Other: Placebo

Intervention

EXPERIMENTAL

The ER training protocol consists of 3 phases, baseline, training, and test. The baseline phase consists of 45 trials which calculates the balance point at which the participant rates a face as 'happy' rather than 'disgusted' over a continuum of 15 faces ranging from happy through ambiguous to disgust. 3 training blocks are then administered with 30 trials per block. Behavioural feedback is given during training (correct/incorrect) based on the participant's balance point however this balance point is adjusted by 2 points on the 15 face continuum to train the participant to rate more faces as 'happy'. A test phase, identical to the baseline phase, is then administered to reassess the participant's balance point. The task takes approximately 15 minutes to complete all 3 phases.

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

Emotion Recognition Training

Intervention
PlaceboOTHER

Placebo Training

Placebo

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Those who score above the cut-off on the SPAI-C

You may not qualify if:

  • Those with a diagnosed mental health disorder
  • Those who are currently attending a mental health professional
  • Those scoring below the cut-off on the SPAI-C
  • Those who decline to participate
  • Those whose parents/guardians do not provide written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • Adams S, Penton-Voak IS, Harmer CJ, Holmes EA, Munafo MR. Effects of emotion recognition training on mood among individuals with high levels of depressive symptoms: study protocol for a randomised controlled trial. Trials. 2013 Jun 1;14:161. doi: 10.1186/1745-6215-14-161.

    PMID: 23725208BACKGROUND
  • Penton-Voak IS, Bate H, Lewis G, Munafo MR. Effects of emotion perception training on mood in undergraduate students: randomised controlled trial. Br J Psychiatry. 2012 Jul;201(1):71-2. doi: 10.1192/bjp.bp.111.107086. Epub 2012 Apr 26.

    PMID: 22539781BACKGROUND
  • Penton-Voak IS, Thomas J, Gage SH, McMurran M, McDonald S, Munafo MR. Increasing recognition of happiness in ambiguous facial expressions reduces anger and aggressive behavior. Psychol Sci. 2013 May;24(5):688-97. doi: 10.1177/0956797612459657. Epub 2013 Mar 26.

    PMID: 23531485BACKGROUND
  • Yoon KL, Zinbarg RE. Threat is in the eye of the beholder: social anxiety and the interpretation of ambiguous facial expressions. Behav Res Ther. 2007 Apr;45(4):839-47. doi: 10.1016/j.brat.2006.05.004. Epub 2006 Jun 23.

    PMID: 16797485BACKGROUND
  • Button K, Lewis G, Penton-Voak I, Munafo M. Social anxiety is associated with general but not specific biases in emotion recognition. Psychiatry Res. 2013 Nov 30;210(1):199-207. doi: 10.1016/j.psychres.2013.06.005. Epub 2013 Jul 9.

    PMID: 23845415BACKGROUND
  • Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.

    PMID: 20855043BACKGROUND
  • Wittchen HU, Fehm L. Epidemiology and natural course of social fears and social phobia. Acta Psychiatr Scand Suppl. 2003;(417):4-18. doi: 10.1034/j.1600-0447.108.s417.1.x.

    PMID: 12950432BACKGROUND
  • Wittchen HU, Carter RM, Pfister H, Montgomery SA, Kessler RC. Disabilities and quality of life in pure and comorbid generalized anxiety disorder and major depression in a national survey. Int Clin Psychopharmacol. 2000 Nov;15(6):319-28. doi: 10.1097/00004850-200015060-00002.

    PMID: 11110007BACKGROUND
  • American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013.

    BACKGROUND
  • Neil AL, Christensen H. Efficacy and effectiveness of school-based prevention and early intervention programs for anxiety. Clin Psychol Rev. 2009 Apr;29(3):208-15. doi: 10.1016/j.cpr.2009.01.002. Epub 2009 Jan 25.

    PMID: 19232805BACKGROUND
  • Otto MW, Smits JA, Reese HE. Cognitive-behavioral therapy for the treatment of anxiety disorders. J Clin Psychiatry. 2004;65 Suppl 5:34-41.

    PMID: 15078117BACKGROUND
  • Carleton RN, McCreary DR, Norton PJ, Asmundson GJ. Brief fear of negative evaluation scale-revised. Depress Anxiety. 2006;23(5):297-303. doi: 10.1002/da.20142.

    PMID: 16688736BACKGROUND
  • Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.

    PMID: 10517055BACKGROUND
  • Crocetti E, Hale WW 3rd, Fermani A, Raaijmakers Q, Meeus W. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED) in the general Italian adolescent population: a validation and a comparison between Italy and The Netherlands. J Anxiety Disord. 2009 Aug;23(6):824-9. doi: 10.1016/j.janxdis.2009.04.003. Epub 2009 Apr 23.

    PMID: 19427168BACKGROUND
  • 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: 10937431BACKGROUND
  • Mathyssek CM, Olino TM, Hartman CA, Ormel J, Verhulst FC, Van Oort FV. Does the Revised Child Anxiety and Depression Scale (RCADS) measure anxiety symptoms consistently across adolescence? The TRAILS study. Int J Methods Psychiatr Res. 2013 Mar;22(1):27-35. doi: 10.1002/mpr.1380. Epub 2013 Mar 11.

    PMID: 23483654BACKGROUND
  • Beidel DC, Turner SM, Morris The Social Phobia and Anxiety Inventory for Children (SPAI-C). Toronto, ON, Multi-Health Systems, 1998.

    BACKGROUND
  • Inderbitzen-Nolan H, Davies CA, McKeon ND. Investigating the construct validity of the SPAI-C: comparing the sensitivity and specificity of the SPAI-C and the SAS-A. J Anxiety Disord. 2004;18(4):547-60. doi: 10.1016/S0887-6185(03)00042-2.

    PMID: 15149713BACKGROUND
  • Rawdon C, Murphy D, Motyer G, Munafo MR, Penton-Voak I, Fitzgerald A. An investigation of emotion recognition training to reduce symptoms of social anxiety in adolescence. Psychiatry Res. 2018 May;263:257-267. doi: 10.1016/j.psychres.2018.02.023. Epub 2018 Feb 8.

MeSH Terms

Conditions

Anxiety DisordersDepressionPhobia, Social

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorPhobic Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Amanda Fitzgerald, PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11