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RECRUITING
NCT07818876
NA

Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety: R33 Phase

Sponsor: University of Denver

View on ClinicalTrials.gov

Summary

Anxiety is chronic, debilitating, and the most common mental health problem across development, costing the U.S. over $42 billion annually. This phased innovation grant will test a symptom-personalized cognitive bias modification for interpretation bias (CBM-I) as a mechanistic intervention to reduce interpretation bias and, subsequently, anxiety, in clinically anxious youth. In this R33 trial, participants will be youth ages 10 to 17 (N=72) with a primary "big three" anxiety disorder (i.e., Generalized, Separation, Social). Youth will be randomly assigned to receive either 16 sessions of personalized CBM-I (the optimal dose identified in the R61 Phase of this study) or equivalent time (four one-hour sessions) over four weeks of a cognitive restructuring (CR), intervention. Both interventions aim to modify threat-focused thinking. Please note that the first phase of the trial (R61: NCT04245501 under NIMH award R61MH121552) has been completed and currently this record summary only reflects the R33 phase.

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-08-21

Completion Date

2028-08

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

OTHER

Cognitive Bias Modification for Interpretations (CBM-I)

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 b

OTHER

Cognitive Restructuring (CR)

Adapted from well-tested manual, The Coping Cat (child and adolescent versions), administered by trained, supervised therapists. Duration of CR is matched to CBM-I in regard to total time in intervention across four weeks.

Locations (1)

University of Denver

Denver, Colorado, United States