Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence

Florida State University

Status: Completed

Conditions: Anxiety

Treatments: Other: Attention Bias Modification

Study type: Interventional

Funder types: Other

Identifiers

NCT03176004

MH106477

Details and patient eligibility

About

This is a multi-site study to examine error-related brain activity (i.e., the error-related negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated by two years. The study examines the degree to which error-related negativity can predict anxiety prospectively over two years, and whether a computerized game that alters attention to threat can alter error-related negativity and trajectories of anxiety.

Full description

Approximately 600 youths between the ages of 11 and 14 and their parents will be assessed. Adolescents will be evaluated at baseline using event-related potentials, self-report, and interview-based measures. The error-related negativity will be evaluated immediately (it takes less than 5 minutes to process and score a single subjects' error-related negativity ), and adolescents with good error-related negativity data (~90%, based on scorable error-related negativity data) will be randomly assigned to either an 8-week (i.e., 16 session) adaptive attention bias modification (N=180) or control condition (N=180) or a waitlist condition (N=180) group. Each session lasts 20 minutes, and participants will be asked to complete two 20-minute sessions per week. Participants will be assessed immediately at post, using the same measures from the baseline assessment. All participants will complete a 2-year follow-up lab visit using the same measures from the baseline assessment.

Enrollment: 600 patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children and parent must speak English well enough to complete the study assessments

Exclusion criteria

• current threat of harm to self or others, bipolar illness, psychosis, thought disorder, pervasive developmental disorder, mental retardation, neurological diseases that impair cognition, or significant head injuries (past 3 months).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 3 patient groups

Attention Bias Modification

Experimental group

Description:

Participants play a game in which they can move up in levels by reducing their reaction time to targets presented in the location of a threatening word.

Treatment:

Other: Attention Bias Modification

Active Control Condition

Active Comparator group

Description:

Participants play a game in which they can move up in levels by reducing their reaction time to targets presented in the location of a word with a specific color.

Treatment:

Other: Attention Bias Modification

Wait List

No Intervention group

Description:

Participants simply return after 8 weeks.