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

NCT04245501 | Completed Results DMC

• 2 other identifiers: 1R61MH121552-011R61MH121552
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorders

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 amiguous 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).

  6 weeks; post-intervention time point

• 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. H

  6 weeks; post-intervention time point

• 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.

  6 weeks; post-intervention time point

Secondary Outcomes (2)

• Number of Trainings Completed of 16 Intended Sessions

  6 weeks; post-intervention time point

• Participant/Parent Acceptability Questionnaire (PAQ)

  6 weeks

Study Arms (2)

Cognitive Bias Modification for Interpretations (CBM-I)

EXPERIMENTAL

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)

Interpretation Control Condition (ICC)

PLACEBO COMPARATOR

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.

Other: Interpretation Control Condition (ICC)

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 bias.

Also known as: Interpretation bias modification, Interpretation training

Cognitive Bias Modification for Interpretations (CBM-I)

Interpretation Control Condition (ICC) OTHER

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.

Interpretation Control Condition (ICC)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Denver: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

BRAVE Lab, Department of Psychology, University of Denver

Denver, Colorado, 80210, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Anxiety, Separation; Phobia, Social; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders; Phobic Disorders

Limitations and Caveats

The trial was funded in January 2020, and recruitment scheduled to begin in April 2020. COVID shutdowns in March 2020 led to delays in initiating recruitment, continued delays in recruitment, and COVID-related illnesses that led to enrolled participants rescheduling their in-person study visits beyond the initially scheduled 6 weeks of study participation for the first 2.5 years of recruitment. Our analytic method allows for controlling for number of days in study to address this.

Results Point of Contact

• Title: Michelle Rozenman, Ph.D., Director, BRAVE Lab & Associate Professor, Department of Psychology
• Organization: University of Denver

michelle.rozenman@du.edu

303-871-6448

Study Officials

• Michelle S Rozenman, Ph.D.

  University of Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychology

Model Details: 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).

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 29, 2020
• Study Start: June 20, 2020
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)