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
|Condition or disease||Intervention/treatment||Phase|
|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|
|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).|
|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|
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.
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.
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.
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.
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.||email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Michelle Rozenman, Ph.D.|
|Principal Investigator:||Michelle S Rozenman, Ph.D.||University of Denver|