Attention Bias Modification Training for Young People

NCT02270671 | Completed Results

• 1 other identifier: HS-14-49-Fitzgerald
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Attention bias modification training (ABMT) is a computer-based attention training programme designed to modify the way a person's attention is directed to mild threats in the environment. What a person focuses their attention on plays an important role in how safe or unsafe they feel in certain situations. Much research has shown that people with high levels of anxiety tend to focus their attention on negative information in their surroundings. The purpose of ABMT is to set in place attention patterns that do not lead to excessive anxiety. The present study will test whether this treatment is effective in reducing social anxiety in 15-18 year olds in school settings. The study design consists of two phases. During Phase 1 participants will complete a screening questionnaire in relation to their wellbeing and emotions. 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-week computer-based attention training programme. The purpose of this phase is to see if ABMT will help young people feel less worried or nervous in social situations by teaching them to focus on their environment differently. Previous research containing attention training tasks similar to this training programme suggests that attention training can reduce symptoms of social anxiety in adolescents. Individuals who are invited to take part in the training session will be randomly assigned to either the intervention (ABMT) or placebo (inactive) group. Both groups will be asked to complete a 4-week programme involving one computer training session per week (each session takes approximately 15-20 minutes). Questionnaires will also be given to participants to complete before and after the intervention, along with a 12-week follow up assessment. These will include questionnaires to measure social anxiety, depressive symptoms, and fears in relation to negative evaluation. Each questionnaire will take approximately 40 minutes to complete. Participants will not know whether they have received the intervention or placebo training until after the intervention.

Conditions

Anxiety; Depression

Keywords

Social Anxiety; Social Phobia; Depression; Attention Bias Modification Training

Outcome Measures

Primary Outcomes (2)

• Threat Bias Measurement at 4-week Post-intervention and 12-week Follow-up

  The bias measurement protocol consists of 120 trials (80 angry-neutral and 40 neutral-neutral presentations). Angry face location, probe location, probe type and actor are all fully counterbalanced in presentation. The participant must perform with more than 70% accuracy on the first 10 trials.The threat bias measurement consisted of 120 trials of the dot-probe task, 80 of which contained angry-neutral face pairs and 40 of which contained neutral-neutral face pairs. The threat bias score equal the mean of neutral NT trials minus mean of threat NT trials. A threat bias scores \>0 indicate a bias towards threat, whereas scores \<0 mean that the participant is slower to respond to threatening stimuli than neutral stimuli. Reaction times were measured in milliseconds.

  Post-intervention (week 4), and 12-week follow-up

• Social Phobia and Anxiety at 4-week Post-intervention and 12-week Follow-up

  The Social Phobia and Anxiety Inventory for Children (SPAI-C)(Beidel et al., 1998, 2000) is a 26-item, self-report measure exploring anxiety in social situations. Responses are indicated using a 3-point Likert scale from 0 = never or hardly ever to 2 = most of the time or always with scores ranging from 0-52. Higher scores on the SPAI-C represent higher levels of social anxiety.

  Post-intervention (week 4), and 12-week follow-up

Secondary Outcomes (3)

• Fear of Negative Evaluation at 4-week Post-Intervention and 12-week Follow-Up

  Post-intervention (week 4), and 12-week follow-up

• Anxiety Related Disorders at 4-week Post-intervention and 12-week Follow-up

  Post-intervention (week 4), and 12-week follow-up

• Depression Symptoms at 4-week Post-intervention and 12-week Follow-up

  Post-intervention (week 4), and 12-week follow-up

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.

Other: Placebo

Intervention

EXPERIMENTAL

The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.

Behavioral: ABMT

Interventions

ABMT BEHAVIORAL

Attention Bias Modification Training

Intervention

Placebo OTHER

Placebo Training

Placebo

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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

Sponsors & Collaborators

• University College Dublin: lead
• Tel Aviv University: collaborator

Related Publications (23)

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  BACKGROUND

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  BACKGROUND

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  PMID: 20855043 BACKGROUND

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  PMID: 16688736 BACKGROUND

• 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.

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• 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.

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  PMID: 23483654 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: 15149713 BACKGROUND

• EU Commission. Toolkit Gender in EU-funded research. Luxembourg, Publications Office of the European Union, 2007.

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Phobia, Social

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Phobic Disorders

Results Point of Contact

• Title: Dr Amanda Fitzgerald
• Organization: University College Dublin

amanda.fitzgerald@ucd.ie

+35317168541

Study Officials

• Amanda Fitzgerald, Ph.D.

  University College Dublin

  PRINCIPAL INVESTIGATOR

• Barbara Dooley, Ph.D.

  University College Dublin

  PRINCIPAL INVESTIGATOR

• Yair Bar-Haim, Ph.D.

  Tel Aviv University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 20, 2018
• Results First Posted: November 20, 2018

Record last verified: 2018-11