Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety
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ClinicalTrials.gov Identifier: NCT04245501 |
Recruitment Status :
Recruiting
First Posted : January 29, 2020
Last Update Posted : August 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Anxiety Disorders | Other: Cognitive Bias Modification for Interpretations (CBM-I) Other: Interpretation Control Condition (ICC) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Eligible youth will be randomly assigned to receive either 16 sessions of a personalized cognitive bias modification for interpretation bias (CBM-I) intervention or a computerized interpretation control condition (ICC). Regardless of randomization, participants will complete 16 sessions of their assigned condition within 4 weeks (1 in-lab training per week, and 3 at-home trainings per week). |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Both participants and outcome assessors will be blind to condition. Unblinding occurs following all post-intervention assessment (i.e., after 16 CBM-I or ICC sessions). |
Primary Purpose: | Treatment |
Official Title: | Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety |
Actual Study Start Date : | June 20, 2020 |
Estimated Primary Completion Date : | September 10, 2022 |
Estimated Study Completion Date : | September 10, 2022 |
Arm | Intervention/treatment |
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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.
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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 bias.
Other Names:
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Placebo Comparator: Interpretation Control Condition (ICC)
Computerized 16-session intervention that is not believed to significantly modify bias. In this study, youth see stimuli personalized to their anxiety symptoms. During ICC sessions, youth see word-sentence pairs and are required to indicate whether word and sentence are related, but are not provided with feedback that aims to "train" a reduction in interpretation bias.
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Other: Interpretation Control Condition (ICC)
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. |
- Change in linguistic interpretation bias as assessed by the word-sentence association paradigm for youth (WSAP-Y) [ Time Frame: baseline, 6 weeks ]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.
- Change in visual interpretation bias as assessed by the ambiguous faces task [ Time Frame: baseline, 6 weeks ]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.
- Change in self-reported interpretation bias as measured by the Children's Automatic Thoughts Scale (CATS) [ Time Frame: baseline, 6 weeks ]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 interpretations (i.e., worse score).
- Feasibility of CBM-I: Proportion of CBM-I trainings completed of 16 intended sessions. [ Time Frame: baseline, 6 weeks ]Proportion of CBM-I trainings completed of 16 intended sessions.
- Participant/Parent Acceptability Questionnaire (PAQ) [ Time Frame: baseline, 6 weeks ]The Participant Acceptability Questionnaire is a 10-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.

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Ages Eligible for Study: | 10 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245501
Contact: Anni R Subar, B.A. | 303-871-6448 | bravelab@du.edu |
United States, Colorado | |
BRAVE Lab, Department of Psychology, University of Denver | Recruiting |
Denver, Colorado, United States, 80210 | |
Contact: Anni Subar, B.A. 303-871-6448 bravelab@du.edu | |
Principal Investigator: Michelle Rozenman, Ph.D. |
Principal Investigator: | Michelle S Rozenman, Ph.D. | University of Denver |
Responsible Party: | Michelle Rozenman, Assistant Professor, Department of Psychology, University of Denver |
ClinicalTrials.gov Identifier: | NCT04245501 |
Other Study ID Numbers: |
1R61MH121552-01 ( U.S. NIH Grant/Contract ) 1R61MH121552 ( U.S. NIH Grant/Contract ) |
First Posted: | January 29, 2020 Key Record Dates |
Last Update Posted: | August 18, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Child Adolescent Pediatric Youth Anxiety Separation anxiety Social phobia Social anxiety Generalized anxiety Interpretation bias Cognitive bias |
Cognitive bias modification Interpretation bias modification Randomized controlled trial Threat bias Threat interpretation Intervention Randomized Cognitive training National Institute of Mental Health Personalized |
Anxiety Disorders Mental Disorders |