Clinical trial NCT02156531: Cognitive Bias Modification for Youth Anxiety
Official title: An Efficacy-Effectiveness Trial of Cognitive Bias Modification for Youth Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Youth Anxiety
CBM
Cognitive Bias Modification
Adolescents
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-06-05
Enrollment: 488
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical effectiveness
timeFrame: 6 month follow up (post intervention)
Secondary outcomes:
measure: Cost Effectiveness
timeFrame: 12 months post intervention
Other outcomes:
measure: Exploration of moderators associated with CBM effects
timeFrame: 12 months post intervention
measure: Exploration of mediators associated with CBM effects
timeFrame: 12 months post intervention
measure: Exploration of process variables associated with CBM effects
timeFrame: 12 months post intervention
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Greg Clarke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Robin Weersing, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Nader Amir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reetz S, Clarke G, Weersing R, Amir N, Dickerson J, Lynch FL, Leo MC, Rawlings AM, Lee MH, Gille S. The ReThink study: a 3-arm parallel randomized trial of cognitive bias modification, with and without adherence promotion, for adolescent anxiety disorder: trial design and protocol. BMC Psychiatry. 2019 Oct 22;19(1):306. doi: 10.1186/s12888-019-2296-z.