Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Cognitive Bias Modification for Interpretations (CBM-I); Interpretation Control Condition (ICC)
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Other intervention name(s): Interpretation bias modification; Interpretation training
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)
Primary purpose: Treatment
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