Cognitive Bias Modification for Youth Anxiety

Study Overview
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Brief Summary
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Research in the last fifteen years suggests that anxious individuals selectively attend towards threatening information. Attention modification interventions for internalizing adults have been developed to target cognition at this basic level; these programs have demonstrated initial efficacy in attention bias and anxiety symptom reduction. To date, there have been minimal published studies of attention modification in youths with clinical levels of anxiety. This study is a large randomized efficacy-effectiveness trial (N = 498) to test the benefit of this low-cost, computerized attention modification intervention (Cognitive Bias Modification (CBM) computer application) for anxiety disorders and symptomatology in youth ages 12 to 17. This trial conducted will compare three intervention arms, all of which include underlying treatment as usual (TAU). The investigators directly test the level of clinical support (scaffolding) needed to adequately deliver self-administered CBM to anxious youth, a finding that will be key to preparing for future deployment-focused trials. The investigators will compare an attention control version of the CBM program (Arm 1) to two active versions of the CBM intervention that have varying levels of patient clinical support: a self-administered CBM program that participants download and install on their home computers (Self-Administered CBM-only; Arm 2), and the same CBM program paired with an adherence promotion (AP) component delivered via brief telephone calls from study coaches, including as needed, brief motivational enhancement and/or technical assistance (Self-Administered CBM+AP; Arm 3). The investigators expect that youth receiving CBM and CBM+AP will have improvement in anxiety symptoms and functioning. The investigators will also complete a cost-effectiveness analysis to examine potential costs offset by this intervention.

Official Title
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An Efficacy-Effectiveness Trial of Cognitive Bias Modification for Youth Anxiety

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM)
* Behavioral: Self-Administered, minimally effective attention-control version of the CBM program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Youth age between 12.0 and 17.9 years old Youth, parent able to complete assessments in English Youth performing at 7th-12th grade achievement level Youth vision sufficient to read book of typical size print Youth access to home computer, Internet for 3 months Assessment of Childhood Disorders (ADIS)-confirmed diagnosis of generalized anxiety disorder (GAD) and/or social phobia (SOP) and/or separation anxiety disorder (SAD) Exclusion Criteria: Youth diagnosis of learning or processing problem Youth diagnosis of attention deficit hyperactivity disorder (ADHD), except if symptoms are stable and controlled by medication for > 1 mo. Youth diagnosis of psychotic disorder Youth primary complaint of condition other than anxiety (as determined by the research interviewer during the baseline survey) psychotic features or delayed inform/visual processing

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Attention Control Condition<br>3.c.14.5. Arm 1: Attention Control Condition. The minimally effective attention-control group procedure is identical to the active CBM procedure except that during the presentation of the trials where a disgusted face is present, the probe will appear with equal frequency (50-50) in the position of disgusted or neutral face. Thus, the balanced (random) presentation of the probe in this condition is not designed to explicitly train attention away from threat and toward neutral stimuli, in contrast to the active versions of CBM in Arms 2 and 3. | Behavioral: Self-Administered, minimally effective attention-control version of the CBM program<br>* Identical to the active CBM program except that during the presentation of the trails where a disgusted face is present, the probe will appear with equal frequency (50-50) in the position of disgusted or neutral face. This, the balanced (random) presentation of the probe in this condition is not designed to explicitly train attention away from threat and toward neutral stimuli, in contrast to the active version of CBM.<br>|
| Experimental: Arm 2: Self-administered CBM only<br>3.c.14.6. Arm 2: Self-Administered CBM Only. Youth assigned to this arm will receive the self-administered active CBM intervention. As described above in detail, in the 80% of CBM trials where a neutral and disgust face are both presented, the probe always replaces the neutral face. Thus, participants are trained to disengage their attention from threat. These youth do not receive Adherence Promotion telephone calls. | Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM)<br>* Cognitive Bias Modification (CBM) is a novel treatment delivered via a downloadable computer program. CBM retrains individuals' attention away from negative/threatening stimuli and toward more balanced attention toward neutral stimuli.<br>|
| Experimental: Arm 3: Self-administered CBM + Adherence Promotion<br>3.c.14.7. Arm 3: Self-Administered CBM + Adherence Promotion. Youth assigned to this arm will receive both the self-administered active CBM intervention and the telephone coach calls to deliver the Adherence Promotion (AP) procedures. AP procedures are intended to compensate for the important nonspecific 'scaffolding' provided by research staff when CBM has been traditionally delivered in laboratories. This includes technical assistance with use of the program, support/encouragement, motivational enhancement, and brainstorming solutions to barriers to regular sessions. The addition of AP to the 3rd arm of this trial attempts to recreate much of this nonspecific, yet likely important, support of in-person interventions, which we hypothesize will lead to greater participant adherence to the program and therefore better clinical outcomes. | Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM)<br>* Cognitive Bias Modification (CBM) is a novel treatment delivered via a downloadable computer program. CBM retrains individuals' attention away from negative/threatening stimuli and toward more balanced attention toward neutral stimuli.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness | We hypothesize that CBM can be successfully delivered in this health-care setting, and that active CBM will demonstrate clinical effectiveness. Hypothesis 1a: The combined active CBM conditions will lead to greater rates of remission for anxiety diagnoses and to greater improvement on secondary indices of symptoms, diagnoses, and functioning, compared to the control condition (Arms 2 + 3 vs. Arm 1). Hypothesis 1b: CBM+AP will result in greater rates of remission for anxiety diagnoses (primary outcome) and greater improvement in secondary clinical indices, compared to CBM-only (Arm 3 vs. Arm 2). | 6 month follow up (post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost Effectiveness | Overall, we expect that active CBM will be cost-effective from the healthcare organization perspective, including patient direct and indirect costs. Hypothesis 2a: Incremental cost-per-unit of anxiety-free-days (AFDs) and health-related quality of life (QALYS) will be lower for active CBM (Arm 2 + Arm 3), relative to the control condition (Arm 1) due to improvements in anxiety symptomology. Hypothesis 2b: Cost-per-unit of improved AFDs and QALYS will be lower in CBM-only (Arms 2) relative to CBM+AP (Arm 3). Although we expect both active CBM arms to improve anxiety, we expect that CBM+AP (Arm 3) will be considerably more costly due to increased labor costs of AP phone coaching, while producing only a moderate incremental clinical benefit beyond the effects of CBM only (Arm 2) | 12 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Youth Anxiety, CBM, Cognitive Bias Modification, Adolescents