Cognitive Bias Modification for Youth Anxiety

Anxiety Clinical Trial

— TeenCBM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02156531
• Other study ID #: 1R01MH101118-01A1
• Secondary ID: 1R01MH101118-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2019

Study information

• Verified date: August 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 488
• Est. completion date: November 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Self-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.
• Self-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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploration of moderators associated with CBM effects	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.	12 months post intervention
Other	Exploration of mediators associated with CBM effects	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.	12 months post intervention
Other	Exploration of process variables associated with CBM effects	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.	12 months post intervention
Primary	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	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