Threat Interpretation Bias as Cognitive Marker and Treatment Target in Pediatric Anxiety: R33 Phase

Summary

Anxiety is chronic, debilitating, and the most common mental health problem across development, costing the U.S. over $42 billion annually. This phased innovation grant will test a symptom-personalized cognitive bias modification for interpretation bias (CBM-I) as a mechanistic intervention to reduce interpretation bias and, subsequently, anxiety, in clinically anxious youth. In this R33 trial, participants will be youth ages 10 to 17 (N=72) with a primary "big three" anxiety disorder (i.e., Generalized, Separation, Social). Youth will be randomly assigned to receive either 16 sessions of personalized CBM-I (the optimal dose identified in the R61 Phase of this study) or equivalent time (four one-hour sessions) over four weeks of a cognitive restructuring (CR), intervention. Both interventions aim to modify threat-focused thinking. Please note that the first phase of the trial (R61: NCT04245501 under NIMH award R61MH121552) has been completed and currently this record summary only reflects the R33 phase.

Eligibility

Inclusion Criteria:

* Provision of signed and dated informed consent form by parent/legal guardian and signed youth assent. If youth turns 18 after study entry (i.e., Visit 1), they will need to reconsent as an adult to continue participation. Youth and consenting parent/legal guardian agree to 6-week study participation as part of consent/assent process.
* Youth and parent/legal guardian speak sufficient English to engage in study procedures.
* Youth is aged 10 to 17 inclusive, at time of signing consent/assent and completion of Visit 1 procedures.
* Youth meets full diagnostic criteria for primary Generalized Anxiety Disorder, Separation Anxiety Disorder, or Social Anxiety Disorder as assessed by the Anxiety Disorders Interview Schedule-IV (ADIS-IV) during Visit 1. Note: the ADIS diagnostic criteria are only valid for two weeks. For the purposes of our study, a youth should be randomized, have randomization revealed, and be in treatment (i.e., complete Visit 2) within 14 days of Visit 1 diagnostic/clinical interview. If this timeline is not met, clinical measures may need to be updated with the youth and parent/legal guardian, although consent does not need to be re-obtained. Parent and youth versions of the Screen for Child Anxiety Related Emotional Disorders, as well as the Pediatric Anxiety Rating Scale and Clinician's Global Impressions - Severity/Improvement Scale might also be re-administered. The ADIS will need to be reviewed to assess whether there have been any diagnostic changes during the elapsed time period. If more than one month has elapsed from the time of baseline, all measures within baseline procedures would be readministered, including reconsenting parent/legal guardian and youth. All such cases must be triaged in the next immediate weekly Project Management meeting.
* Youth otherwise meeting study entry criteria, who are receiving treatment for a stable medical or psychiatric condition, may be included providing that medication and dose have been stable for at least six weeks (e.g., stable dose of stimulant medication for Attention-Deficit/Hyperactivity Disorder) prior to study entry and remain stable on that medication and dose throughout their study participation. Changes to medication during study participation following randomization at Visit 2 will be considered non-urgent protocol deviations and will be tracked in the Protocol Deviations Form. Youth would not be removed from the study in this case, but their data may be excluded from sensitivity analyses.
* Youth must have a standard score of at least 85 on the Wechsler Abbreviated Scale of Intelligence, Vocabulary and Matrix Reasoning subtests, as well as the Wide Range Achievement Test-4 Reading subtest (administered during Visit 1) to ensure ability to read and understand stimuli during interpretation bias assessments and CBM-I.
* Youth must have access to a desktop or laptop computer and access to internet at home or can access one at their school or local library for the at-home portion of the computer training program. For youth without access, families can agree to complete all 16 CBM-I trainings (if randomized to CBM-I) at the BRAVE Lab.

Exclusion Criteria:

* Requires treatment other than CBM-I/CR: namely, youths with severe anxiety indicating need for higher level of care (e.g., psychiatric hospitalization), or primary major depressive disorder, bipolar disorder, psychosis, safety concerns due to recent or current acute suicidal ideation with plan, intent, and/or attempt that warrants alternate intervention, Posttraumatic Stress Disorder, substance dependence, current physical or sexual abuse, or intellectual disability. This will be determined during the Visit 1 ADIS interview. Consultation with the PI will occur in all cases where another mental health concern may be primary and/or warrant more immediate treatment.
* At Visit 1, is currently in alternate psychosocial intervention for any reason or has plans to initiate any psychosocial intervention for any reason.
* Has previously received any type of cognitive bias modification (attention or interpretation bias as target) at the BRAVE Lab or elsewhere.
* The family indicates they are no longer interested or able to participate in the study after Visit 1 (in which it is determined that the family is eligible) but before the family is randomized or told of their randomization. The youth will be excluded and not included in ITT analyses, and the randomization will be "thrown back" into the randomization scheme.
* Has significant uncorrected vision impairment (e.g., uncorrected blindness) that precludes participation in the computerized assessment and intervention components of the study.

Conditions2

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