Cognitive Bias Modification for Youth Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-11-30

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.

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Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Attention Control Condition

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.

Group Type PLACEBO_COMPARATOR

Self-Administered, minimally effective attention-control version of the CBM program

Intervention Type BEHAVIORAL

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.

Arm 2: Self-administered CBM only

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.

Group Type EXPERIMENTAL

Self-Administered, Active Cognitive Bias Modification (CBM)

Intervention Type BEHAVIORAL

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.

Arm 3: Self-administered CBM + Adherence Promotion

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.

Group Type EXPERIMENTAL

Self-Administered, Active Cognitive Bias Modification (CBM)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No