An interventional study of Intervention and Placebo in Anxiety and Depression, sponsored by University College Dublin. Completed. Open to participants aged 15 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-09.
Sponsored by University College Dublin · Not applicable, Interventional, and Treatment
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.
Social anxiety disorder (SAD) is among the most prevalent mental disorders in adolescence, 10% of females and 5% of males are diagnosed with SAD in adolescence. SAD is characterised by marked fear or anxiety about social situations in which the individual is exposed to possible scrutiny by others. SAD is associated with social isolation, poor social skills, low self-esteem, and future comorbid mental disorders. Social anxiety typically develops during adolescence, thus there is a need to detect and treat it early prior to the development of a clinically-diagnosed SAD. Most early interventions for social anxiety have used Cognitive Behavioural Therapy (CBT), which focuses on modifying explicit verbal cognitions. However, many adolescents do not have access to CBT and many finding it demanding.
Research suggests that individuals who have high levels of social anxiety are more likely to misread facial emotions as threatening or disapproving, and researchers have proposed that the difficulty may lie in decoding low intensity facial expressions rather than identifying facial emotions which are expressed with greater intensity. In social anxiety, a bias towards perceiving ambiguous facial expressions as negative may give rise to avoidant behaviour and maintain or increase symptoms; therefore, this emotion processing bias may be a powerful bias for researchers to target with the aim of developing interventions to reduce symptoms.
ER training provides a promising new line of research which may be beneficial in altering emotion processing biases which maintain or increase symptoms of mental health disorders. Research has shown that ER training may be effective in reducing depressive symptoms in analogue populations with high levels of depression and anger and aggressive behaviour in healthy adults and adolescent youth at high risk of criminal offending and delinquency.
Present Study:
This research tests the effectiveness of ER training in reducing social anxiety in adolescents. Given that the age of onset of social anxiety is adolescence, peaking in late teens, this research focuses on 15-18 year olds.
Aims \& Objectives:
To test the effectiveness of ER training in reducing social anxiety in adolescents. 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.
Central Research Questions:
Is ER training associated with:
I. An increase in the perception of positive (happy) over negative (disgust) emotions in faces displaying ambiguous emotional expressions? II. A decrease in negative evaluations? III. A decrease in social anxiety? IV. A decrease in other forms of anxiety and/or symptoms of depression?
PHASE 1: SCREENING FOR SOCIAL ANXIETY IN ADOLESCENTS Objective: To screen for sub-clinical levels of social anxiety in adolescents. School Sampling: Approximately 8 large second-level schools in Dublin will be randomly selected from the Department of Education and Skills 2012 published list of schools.
Power Analysis: Using G*Power 3.1, the sample size was determined as 111 based on the following parameters: a medium effect size of 0.3, alpha of 0.05, power of 0.8, a repeated measures within-between interaction: 2 (Randomization) X 3 (Pre, Post, Follow-up).
Participants: Adolescents aged 15-18 years in second-level schools will be invited for the initial screening.
Procedure: Adolescents must return parental and informed consent forms. Participants will be screened using the Social Phobia and Anxiety Inventory for Children (SPAI-C). Participants scoring above the cut-off of ≥18 will be invited to participate in the intervention (Phase 2).
Approximately 440 second-level students across 8 schools will be invited to complete screening. With an approximate response rate of 50% (N=220), and using a cut-off of ≥18 120 will be identified (60 per condition).
PHASE 2: RANDOMIZED CONTROL TRIAL Objective: To compare the effectiveness of ER to placebo training in reducing social anxiety.
Participants: Adolescents from Phase 1 screening above a cut-off of ≥18 will be invited to participate in the intervention and will be randomly assigned to ER/placebo training. On the basis of screening, the PI will ensure group equivalence across ER versus placebo groups on key variables (e.g., age, gender, social anxiety) in advance of randomization. Post randomization, independent variables will be checked to ensure they are balanced across groups so as not to contaminate outcomes of the study.
Procedure:
Participants in both ER and placebo training groups will receive 4 training sessions over 4 consecutive days. The intervention will be performed on a laptop during school and delivered in a quiet room with the researcher present. Pre-intervention data will be collected on day 1 prior to training, post-intervention data will be collected on day 4 following training, with a follow-up assessment at 2-weeks post-intervention.
Training Task:
Participants will complete training over 4 consecutive days in schools. Each session will include a computerised training programme comprised of three phases, baseline, training, and test,which will take approximately 15 minutes to complete. A follow-up assessment will be completed two weeks post-intervention. During the 2-week follow-up assessment participants will complete a final assessment of emotion sensitivity using the test phase of the emotion recognition task.
Outcome Measures:
Outcome measure will be administered to all participants in the RCT pre-intervention (baseline on day 1), post-intervention (day 4), and at 2-week follow-up, including:
Emotion Sensitivity Measurement Accuracy assessed using baseline and test measurements at each ER/placebo training session.
Social Phobia and Anxiety Inventory for Children (SPAI-C) The SPAI-C is a 26-item self-report instrument and has good psychometric properties with adolescent samples. The SPAI-C measures the somatic, cognitive, and behavioural aspects of social phobia in children and adolescents. Questions relate to how nervous the respondent feels when carrying out certain tasks and responses are rated on a 3-point scale from never, or hardly ever to most of the time, or always with higher scores indicating greater levels of social anxiety.
Brief Fear of Negative Evaluations Scale - Revised (BFNE-R) Negative evaluations are an important aspect of social anxiety. The BFNE-R is a 12-item measure which assesses fear of negative evaluation. Items are responded to on a 5-point Likert scale from 0 to 4. The BFNE-R has shown high internal consistency and correlates well with the original BFNE.
Screen for Child Anxiety Related Disorders (SCARED) Child Version The SCARED is used to screen for signs of anxiety disorders. The 41-item measure is used to measure anxiety, including panic, separation anxiety, generalised anxiety, social avoidance, and school phobia. It has shown high reliability with adolescents. Items are rated on a 3-point Likert scale. Internal consistencies have been shown to be high with adolescent samples.
Depression Subscale of the Revised Child Anxiety and Depression Scale (RCADS) The RCADS is a 47-item self-report measure and has good psychometric properties with adolescent samples. The Depression Subscale contains 10 items. Items relating to the frequency with which depressive symptoms are experienced are rated on a 4-point Likert scale.
Research Design: A mixed model 2 (Randomization) x 3 (Time) complex design combining between subjects and within subjects conditions will be employed. Each participant will be tested at pre-intervention, post-intervention, and 2-week follow-up.
Independent Variables:
Randomization (K=2; ER training/ Placebo) Time (K=3; Pre-intervention[day 1], Post-intervention [day 4], and Follow-up)
Analyses:
All analyses on change in social anxiety, anxiety, depression, and fear of negative evaluation will be conducted as intention-to-treat analyses.
Descriptive statistics Chi-square analyses and ANOVAs Primary analyses will consist of two-way repeated ANOVAs 2 (Randomization) x 3 (Time) to test the variables under study.
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This study's enrollment of 115 is above the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
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
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
Placebo Training
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)
Time frame: Pre-intervention (day 1), post-intervention (day 4)
Change from baseline in social anxiety at 2-week follow-up
A 26-item self-report questionnaire to measure social anxiety - Social Phobia and Anxiety Inventory for Children (SPAI-C; Biedel et al., 1998)
Time frame: 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
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
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: Pre-intervention (day 1), post-intervention (day 4), and 2-week follow-up
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University College Dublin