CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Cognitive Bias Modification for Interpretations (CBM-I) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04245501
NCT04245501N/ACompleted

Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety

University of Denver·interventional·Posted Jan 29, 2020·Updated Mar 5, 2025

In Brief

A clinical study evaluating Cognitive Bias Modification for Interpretations (CBM-I) and Interpretation Control Condition (ICC) for Anxiety Disorders. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Anxiety is the most common mental health problem in children and adolescents. This two-phased study will test the effects of an experimental computerized intervention aimed at reducing threat-based thinking (i.e., interpretation bias) in anxious youth. Participants in both the R61 (N=46) and R33 (N=72) trials will be youth ages 10 to 17 with a primary anxiety disorder (Separation, Social, Generalized). In the R61 trial, youth will be randomly assigned to receive 16 sessions over 4 weeks of either a personalized cognitive bias modification program for interpretation bias (CBM-I) or a computerized control condition (ICC). If CBM-I reduces interpretation bias significantly more than the ICC, the R33 trial will commence. In the R33, youth will be randomly assigned to either CBM-I or an equal amount of time in a cognitive restructuring intervention, which also aims to reduce threat-based thinking in anxiety. Please note that only the R61 phase of the trial has been completed and currently this record summary only reflects the R61 phase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 29, 2020
Enrollment StartJun 20, 2020
Primary CompletionNov 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.4 years ago

Interventions

Cognitive Bias Modification for Interpretations (CBM-I)other

Computerized intervention in which youth see word-sentence pairs personalized to their anxiety symptoms, and indicate whether these are related. Youth receive feedback aimed to reduce interpretation bias.

Interpretation Control Condition (ICC)other

Computerized control condition in which youth see word-sentence pairs personalized to their anxiety symptoms. Youth indicate whether these are related, but are not provided with feedback that aims to "train" a reduction in interpretation bias.