ClinicalTrials.gov
ClinicalTrials.gov Menu

Emotion Recognition Training for Young People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02550379
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
University of Bristol
Information provided by (Responsible Party):
Dr. Amanda Fitzgerald, University College Dublin

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.


Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Intervention Other: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emotion Recognition Training for Socially Anxious Adolescents: A Randomized Controlled Trial
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Placebo Comparator: Placebo
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
Placebo Training

Experimental: Intervention
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
Emotion Recognition Training




Primary Outcome Measures :
  1. Change from baseline in social anxiety at post-intervention [ Time Frame: Pre-intervention (day 1), post-intervention (day 4) ]
    A 26-item self-report questionnaire to measure social anxiety - Social Phobia and Anxiety Inventory for Children (SPAI-C; Biedel et al., 1998)


Secondary Outcome Measures :
  1. Change from baseline in social anxiety at 2-week follow-up [ Time Frame: Pre-intervention (day 1), 2-week follow-up 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)

  2. Change from baseline in emotion sensitivity measurement at post-intervention and 2-week follow-up [ Time Frame: Pre-intervention (day 1), post-intervention (day 4), 2-week follow-up post-intervention ]
    Emotion sensitivity measurement via shift in balance points across training sessions and at 2-week follow-up assessed using accuracy data from baseline and test phases of the ER/placebo training task

  3. Change from baseline in fear of negative evaluation at post-intervention and 2-week follow-up [ Time Frame: Pre-intervention (day 1), post-intervention (day 4), and 2-week follow-up ]
    A 12-item self-report questionnaire to measure fear of negative evaluation - Brief Fear of Negative Evaluation Questionnaire -Revised (BFNE-R; Carleton et al., 2006)

  4. Change from baseline in anxiety related disorders at post-intervention and 2-week follow-up [ Time Frame: Pre-intervention (day 1), post-intervention (week 4), and 2-week follow-up ]
    A 41-item self-report screening tool for anxiety disorders including panic, separation anxiety, generalized anxiety, social avoidance, and school phobia - Screen for Child Anxiety Related Disorders Child Version (SCARED; Birmaher et al., 1999)

  5. Change from baseline in depression symptoms at post-intervention and 2-week follow-up [ Time Frame: Pre-intervention (day 1), post-intervention (day 4), and 2-week follow-up ]
    A 10-item self-report subscale to assess the frequency of depressive symptoms - The Revised Child Anxiety and Depression Scale - Depression Subscale (RCADS; Chorpita et al., 2000)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550379


Sponsors and Collaborators
University College Dublin
University of Bristol
Investigators
Principal Investigator: Amanda Fitzgerald, PhD University College Dublin

Publications:
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013.
Beidel DC, Turner SM, Morris The Social Phobia and Anxiety Inventory for Children (SPAI-C). Toronto, ON, Multi-Health Systems, 1998.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Amanda Fitzgerald, Lecturer, University College Dublin
ClinicalTrials.gov Identifier: NCT02550379     History of Changes
Other Study ID Numbers: HS-15-41-Fitzgerald
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Amanda Fitzgerald, University College Dublin:
Social Anxiety
Social Phobia
Depression
Emotion Recognition Training

Additional relevant MeSH terms:
Depression
Behavioral Symptoms