N/A
N=50
Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety
Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04245501 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Linguistic Interpretation Bias as Assessed by the Word-sentence Association Paradigm for Youth (WSAP-Y) — 19.77; 47.40 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Bias Modification for Interpretations (CBM-I) (Other); Interpretation Control Condition (ICC) (Other)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- University of Denver
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Linguistic Interpretation Bias as Assessed by the Word-sentence Association Paradigm for Youth (WSAP-Y) |
19.77; 47.40 | — |
| PRIMARY Change in Visual Interpretation Bias as Assessed by the Ambiguous Faces Task |
0.86; 1.32 | — |
| PRIMARY Change in Self-reported Interpretation Bias as Measured by the Children's Automatic Thoughts Scale (CATS) |
6.52; 19.00 | — |
| SECONDARY Number of Trainings Completed of 16 Intended Sessions |
16; 15.83 | — |
| SECONDARY Participant/Parent Acceptability Questionnaire (PAQ) |
47.25; 42.91; 38.61; 33.87 | — |
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.
Eligibility Criteria
Inclusion Criteria
- youth aged 10 to 17
- diagnosed at study baseline with a primary "big three" anxiety disorder (Separation, Social, Generalized)
- standard score greater than or equal to 85 on the Wide Range Achievement Test - Word Reading Subtest (to ensure ability to read stimuli during interpretation bias assessment and CBM-I/ICC), and estimated IQ standard score of at least 80 on the Wechsler Abbreviated Scale of Intelligence
- youth and consenting parent/legal guardian speak sufficient English to complete consent/assent and study procedures
- no concurrent psychosocial services during study participation to reduce likelihood that other interventions are responsible for change in primary or secondary outcomes
- no psychotropic medications with no plans to start medications during study, or six weeks stable on SSRI or psychostimulant medication and dose with no plans to change medication/dose during study
Exclusion Criteria
- severe anxiety indicting that youth requires higher level of care (e.g., intensive treatment such as psychiatric hospitalization), significant diagnostic comorbidity (e.g., presence of psychosis or significant mood disorder), or another primary diagnosis that warrants alternate intervention
- significant uncorrected vision impairment (e.g., uncorrected blindness) that precludes participation in CBM-I/ICC
- safety concerns due to recent or acute suicidality with plan, intent, and/or attempt that warrants alternate intervention
Data sourced from ClinicalTrials.gov (NCT04245501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.