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

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Denver
Study ID
NCT07818876
Status
Recruiting
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Conditions

  • Anxiety Disorders

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

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 b
  • Cognitive Restructuring (CR) — OTHER
    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.

Study Details

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 Dates

First listed
Sep 14, 2026
Start date
Aug 21, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive Bias Modification for Interpretations (CBM-I)
    Computerized 16-session intervention aimed at reducing interpretation bias. In this study, CBM-I is personalized to youth anxiety symptoms. During CBM-I sessions, youth indicate whether word-sentence pairs are related, and are provided with feedback aimed to reduce bias.
  • Active Comparator: Cognitive Restructuring (CR)
    Four session psychosocial intervention aimed at reducing anxiety. CR is a standard treatment technique (and often full intervention protocol) aimed at modifying anxious cognitions by teaching youth to identify when they make threat attributions, consider alternate non-threatening attributions, and thereby change their anxious thought processes, resultant avoidance, and anxiety symptoms.

Primary Outcome Measure

Change in Linguistic Interpretation Bias as Assessed by the Word-sentence Association Paradigm for Youth (WSAP-Y) [ Time Frame: 6 weeks following randomization/start of treatment (post-treatment study visit at Week 6) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of DenverDenverColorado80210
Michelle Rozenman, Ph.D.
[email protected]
303-871-6448
Michelle Rozenman, Ph.D. (PRINCIPAL_INVESTIGATOR)

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University of Denver· Denver, CO

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