Clinical trial NCT04245501: Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety
Official title: Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, Los Angeles
First posted: 2020-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Detailed description: Anxiety is the most common mental health problem in youth, affecting one in four children and adolescents. Unfortunately, evidence-based treatments (pharmacotherapy, cognitive-behavioral therapy) are costly, not widely available, and ineffective for a substantial proportion of youth. In response, experts have called for novel treatments that directly target mechanisms underlying youth anxiety while simultaneously addressing barriers to care (i.e., cost, accessibility). One such promising mechanism is interpretation bias - the inaccurate interpretation of threat from ambiguity. The investigators have previously demonstrated that interpretation bias occurs in over 90% of anxious youth, is predictive of anxiety severity in clinical samples of youth, and differentiates between anxious and non-anxious youth. These data indicate that interpretation bias may be a ubiquitous phenomenon underlying anxiety expression in children and adolescents and therefore may be an ideal intervention target. Cognitive bias modification for interpretation bias (CBM-I) is a computerized intervention that attempts to reduce anxiety by directly modifying interpretation bias. CBM-I has demonstrated preliminary efficacy for reducing anxiety symptoms in adults. Yet extant CBM-I data in anxious youth are sparse, with little work addressing whether CBM-I significantly reduces interpretation bias, and whether this in turn reduces anxiety symptoms, as well as the dose necessary to reduce both bias and anxiety. This two-phased study tests personalized CBM-I in youth ages 10 to 17 who meet diagnostic criteria for a primary anxiety disorder (Separation, Social, Generalized). In the R61 Phase (N=46), a randomized clinical trial (RCT) examines whether CBM-I personalized to youth anxiety symptoms significantly reduces interpretation bias compared to a computerized interpretation control condition (ICC). The interpretation target will be measured at multiple time points (4, 8, 12, 16 sessions) to identify the optimal dose for reduction in interpretation bias. If the R61 trial results indicate that CBM-I outperforms ICC on interpretation bias reduction, the R33 phase will commence. In the 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 cognitive restructuring, a clinically relevant psychosocial intervention that also targets anxious cognition. Please note that only the R61 phase of the trial has been completed and currently this record summary only reflects the R61 phase. If the R33 phase is funded, it will be registered as a separate NCT.

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

Primary outcomes:
measure: Change in Linguistic Interpretation Bias as Assessed by the Word-sentence Association Paradigm for Youth (WSAP-Y)
timeFrame: 6 weeks; post-intervention time point
measure: Change in Visual Interpretation Bias as Assessed by the Ambiguous Faces Task
timeFrame: 6 weeks; post-intervention time point
measure: Change in Self-reported Interpretation Bias as Measured by the Children's Automatic Thoughts Scale (CATS)
timeFrame: 6 weeks; post-intervention time point
Secondary outcomes:
measure: Number of Trainings Completed of 16 Intended Sessions
timeFrame: 6 weeks; post-intervention time point
measure: Participant/Parent Acceptability Questionnaire (PAQ)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: BRAVE Lab, Department of Psychology, University of Denver
state: Colorado
Study officials:
affiliation: University of Denver
name: Michelle S Rozenman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: