Cognitive Bias Modification for Youth Anxiety

NCT02156531 | Unknown DMC

• 1 other identifier: 1R01MH101118-01A1
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; Youth Anxiety; CBM; Cognitive Bias Modification; Adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost Effectiveness

  12 months post intervention

Other Outcomes (3)

• Exploration of moderators associated with CBM effects

  12 months post intervention

• Exploration of mediators associated with CBM effects

  12 months post intervention

• Exploration of process variables associated with CBM effects

  12 months post intervention

Study Arms (3)

Attention Control Condition

PLACEBO COMPARATOR

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.

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

Arm 2: Self-administered CBM only

EXPERIMENTAL

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.

Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM)

Arm 3: Self-administered CBM + Adherence Promotion

EXPERIMENTAL

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.

Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM)

Interventions

Self-Administered, Active Cognitive Bias Modification (CBM) 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 2: Self-administered CBM only; Arm 3: Self-administered CBM + Adherence Promotion

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

Attention Control Condition

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (1)

• 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.

  PMID: 31640613 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Greg Clarke, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Robin Weersing, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Nader Amir, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 5, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

US (1)