An interventional study of Cognitive Bias Modification for Interpretations (CBM-I) and Cognitive Restructuring (CR) in Anxiety Disorders, sponsored by University of Denver. Recruiting at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by University of Denver · Not applicable, Interventional, and Treatment
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.
Anxiety is chronic, debilitating, and the most common mental health problem across development, costing the U.S. over $42 billion annually. As anxiety disorders most commonly onset before age 18, the period from childhood through adolescence offers a critical window within which to intervene. Unfortunately, evidence-based interventions are costly, not widely available, and ineffective for upwards of 50% of youth. In response, pediatric anxiety experts and the National Institute of Mental Health (NIMH) have called for approaches that directly target underlying mechanisms to improve treatments for anxious youth. One such putative mechanism is interpretation bias - the appraisal of environmental ambiguity as threatening. Interpretation bias has been identified as a mechanism underlying the development and maintenance of youth anxiety. We have found that interpretation bias for threat, objectively measured with a paradigm that assesses whether and how quickly youth respond to ambiguous stimuli with threatening appraisals, occurs in 90% of clinically anxious youth, predicts anxiety severity above and beyond clinical characteristics, and differentiates anxious from non-anxious youth. CBM-I is a computerized intervention that attempts to reduce anxiety by directly targeting and reducing interpretation bias. While findings in the child literature are preliminary, studies with adults provide initial support that CBM-I at high dose (i.e., more than a few trainings) may reduce anxiety. This phased innovation grant tests personalized CBM-I in youth ages 10 to 17 who meet diagnostic criteria for a primary anxiety disorder (Generalized, Separation, Social). In the previous R61 Phase (N=50), a randomized clinical trial (RCT) examined whether CBM-I personalized to youth anxiety symptoms significantly reduced interpretation bias compared to a computerized interpretation control condition (ICC) and identified the optimal dose for reduction in interpretation bias. The R61 trial results indicated that CBM-I outperforms ICC on interpretation bias reduction, so the current R33 phase will proceed. In this R33 Phase, an RCT (N=72) will validate whether CBM-I significantly reduces interpretation bias, and conducts a mechanism test (i.e., does bias reduction precede and predict anxiety reduction?), by comparing CBM-I to CR, a clinically relevant psychosocial intervention that also targets anxious cognition.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 72 is close to the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Denver is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Cognitive Bias Modification for Interpretations (CBM-I)
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.
Other: Cognitive Restructuring (CR)
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
Also known as: Interpretation bias modification, Interpretation training
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.
Also known as: Cognitive reframing, Cognitive reappraisal
Change in Linguistic Interpretation Bias as Assessed by the Word-sentence Association Paradigm for Youth (WSAP-Y)
The WSAP-Y is a computerized assessment of interpretation bias in which youth indicate whether word-sentence pairings are related. This measure provides information about the degree to which youth evidence interpretation bias, as well as a behavioral (reaction time) index for bias endorsement. For the primary outcome of percent threat interpretations endorsed, the possible range is 0 (zero) to 100%. Higher percentage indicates more threat interpretation bias (i.e., the youth endorsed a higher proportion of threat words as related to ambiguous sentences); lower scores indicate lower threat interpretation bias. Greater decrease in the percent of threat interpretations endorsed and lower absolute scores indicate "better" outcome (i.e., more reduction in threat interpretation bias; less interpretation bias overall).
Time frame: 6 weeks following randomization/start of treatment (post-treatment study visit at Week 6)
Change in Visual Interpretation Bias as Assessed by the Ambiguous Faces Task
Youth view faces portraying neutral expressions or subtle emotional expressions (i.e., morphed faces ranging in intensity of emotional valence). Youth categorization of faces as neutral or threatening provides their sensitivity and bias for reporting presence of threat. The criterion mean value in outcomes below reflects a score from -1 to 1, with higher negative numbers reflecting greater bias toward angry faces, and higher positive values approaching one reflecting a bias toward happy faces. Theoretically, higher positive values indicate "better" outcome such that youth have more positive bias toward facial stimuli.
Time frame: 6 weeks following randomization/start of treatment (post-treatment study visit at Week 6)
Change in Self-reported Interpretation Bias as Measured by the Children's Automatic Thoughts Scale (CATS)
The Children's Automatic Thoughts Scale is a youth self-report questionnaire which assesses presence and frequency of a variety of anxious thoughts from domains of: physical threat, social threat, personal failure, and anxious hostility. Total scores range from 0 to 160, with higher scores indicating more threat interpretation bias. Higher scores indicate "worse" outcome, or that youth self-report that they have more threatening thoughts and/or threatening thoughts at higher frequency; lower scores indicate "better" outcome or that youth self-report fewer threatening thoughts and/or threatening thoughts at lower frequency.
Time frame: 6 weeks following randomization/start of treatment (post-treatment study visit at Week 6)
Number of CBM-I Trainings Completed of 16 Intended Sessions (CBM-I Arm Only)
This outcome is related to the "feasibility of CBM-I" aim. The number of CBM-I trainings completed of 16 intended sessions. Theoretically, completion of more training sessions is better and indicates that youth received a higher "dose" of training. This outcome only applies to the CBM-I arm.
Time frame: 6 weeks following randomization/start of treatment (post-treatment study visit at Week 6)
Participant/Parent Acceptability Questionnaire (PAQ)
The Participant Acceptability Questionnaire is a 8-item youth and parent report questionnaire, accompanied by an exit interview, that assesses burden (travel, boredom), credibility of computerized intervention techniques, and youth comprehension of the intervention. Parents and youth complete the PAQ separately.
Time frame: 6 weeks following randomization/start of treatment (post-treatment study visit at Week 6)
Anxiety symptom severity - PARS
Anxiety symptom severity as measured by clinician-administered Pediatric Anxiety Rating Scale (PARS). Administered separately to parent and child, and scored by clinician by summing totals for the 7 items. Scores range from 0-35, with higher scores suggesting higher/worse anxiety symptom severity.
Time frame: 6 weeks following randomization/start of treatment (post-treatment study visit at Week 6)
Anxiety symptoms - SCARED
Total anxiety symptoms as measured by the Screen for Anxiety Related Emotional Disorders (SCARED), 41-item version. Each of 41 items ranges from 0-2, total anxiety symptoms calculated by scoring total across all 41 items. Total scores range from 0-82, with higher scores suggesting more/worse anxiety symptoms.
Time frame: 6 weeks following randomization/start of treatment (post-treatment study visit at Week 6)
Plan to share: Yes — Data resulting from this project will be de-identified and uploaded in a timely manner to the National Database for Clinical Trials Related to Mental Illness, including de-identified youth demographic and clinical characteristics, and summary scores from outcome measures, along with a data dictionary that provides variable definitions, value labels, and scoring of measures. The study protocol and dataset may be made available to other investigators based on successful completion of a data request form, following the conclusion of this study and publication of primary outcome papers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available following conclusion of the study and publication of primary outcome papers.
Access criteria: Researchers will be required to complete a request form that includes: research identifying information and institutional affiliation, description of research objectives, and IRB approval. Completed request forms will be reviewed by the PI and Co-Is to ensure that the research request will not duplicate work being conducted by the study team. The requesting researcher must provide signed data sharing agreements from all users on their team outlining the details of how information will be kept secure, consistent with NIMH and University of Denver data sharing guidelines. Requesting researchers will also provide the University of Denver's IRB with an IRB approval from their institution. The data will only be released after the proposed study has been completed and primary outcomes have been accepted for publication.
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