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Behavioral Intervention

Arm 2: Self-administered CBM only for Anxiety (TeenCBM Trial)

N/A
Waitlist Available
Led By Nader Amir, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post intervention
Awards & highlights

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.

Eligible Conditions
  • Anxiety

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical effectiveness
Secondary study objectives
Cost Effectiveness
Other study objectives
Exploration of mediators associated with CBM effects
Exploration of moderators associated with CBM effects
Exploration of process variables associated with CBM effects

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3: Self-administered CBM + Adherence PromotionExperimental Treatment1 Intervention
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 II: Arm 2: Self-administered CBM onlyExperimental Treatment1 Intervention
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 III: Attention Control ConditionPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
551 Previous Clinical Trials
27,690,472 Total Patients Enrolled
7 Trials studying Anxiety
1,843 Patients Enrolled for Anxiety
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,048 Total Patients Enrolled
86 Trials studying Anxiety
39,835 Patients Enrolled for Anxiety
Nader Amir, PhDPrincipal InvestigatorSan Diego State University
2 Previous Clinical Trials
62 Total Patients Enrolled
~44 spots leftby Sep 2025