Anxiety
Conditions
Keywords
Anxiety, Youth Anxiety, CBM, Cognitive Bias Modification, Adolescents
Brief summary
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.
Interventions
BEHAVIORALSelf-Administered, Active Cognitive Bias Modification (CBM)
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.
BEHAVIORALSelf-Administered, minimally effective attention-control version of the CBM program
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.
Sponsors
National Institute of Mental Health (NIMH)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical effectiveness | 6 month follow up (post intervention) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness | 12 months post intervention | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploration of moderators associated with CBM effects | 12 months post intervention | We will focus on moderators that may influence future dissemination, including whether CBM is robust to variation in youth clinical severity (e.g., baseline Clinical Global Impressions scale (CGI), severity of cognitive biases), comorbidity (e.g., depression), and demographics (e.g., gender, socioeconomic status, race/ethnicity). Our large sample allows for substantial variability on these characteristics. |
| Exploration of mediators associated with CBM effects | 12 months post intervention | We will examine whether change in attentional bias mediates CBM effects and leads to improved anxiety, as posited by information-processing theories underlying the intervention. |
| Exploration of process variables associated with CBM effects | 12 months post intervention | We will examine youth adherence to CBM, benchmarked against lab-based delivery of similar interventions (i.e., acceptable error rates) - this will include testing whether the CBM+AP condition results in higher participant engagement and compliance (e.g., high completion rates, low error rates) compared to conditions without AP (Arm 3 vs. Arms 1 + 2) and assessment of whether these process variables are associated with outcomes. |
Countries
United States
Outcome results
None listed