Anxiety Disorders
Conditions
Brief summary
This project will test Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder. The purpose of this project is to determine whether ABMT leads to reductions in anxiety and related impairment, relative to a placebo task condition.
Detailed description
This application proposes a pilot test of Attention Bias Modification Training (ABMT) among children and adolescents who have completed a full protocol of cognitive behavior therapy (CBT) for anxiety and still meet criteria for a primary diagnosis of an anxiety disorder a full year after completion of CBT. There is currently not a single empirical study in the youth anxiety treatment literature that has systematically examined a treatment augment for youth who fail to respond to a full course of CBT. Empirical efforts to address this issue are important because youths who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders, experience frustration and demoralization by perceived failure, and likely pose a financial burden on the health care system. ABMT is a novel translational treatment for anxiety based on experimental and neuroscience research findings on attention processes. Research demonstrates that ABMT leads to reductions in anxiety and its disorders. Based on recent theory and research demonstrating an attention bias toward threat predicts CBT nonresponse among anxious youth, researchers have postulated that ABMT may hold promise as an augment to CBT because of its specific focus on attention bias that targets both frontal-cortical and subcortical circuitry. This study will recruit an estimated 70 children and adolescents who have completed a 12-14 week CBT trial for anxiety disorders and at the one year follow-up continue to meet criteria for a primary diagnosis of an anxiety disorders. These 70 children and adolescents (ages 8-16 years) will be randomly assigned to complete eight biweekly sessions of either ABMT or a placebo control (PC) task. Clinician ratings on youth anxiety severity will be collected and evaluated as the primary outcome. Youth self ratings on anxiety symptoms and parent ratings on youth anxiety symptoms will be collected and evaluated as secondary outcomes. All measures will be collected before condition assignment (pretreatment), at immediate posttreatment, and at an eight week follow up. The following specific aims will be addressed. Aim 1: Test whether ABMT leads to significantly lower levels of anxiety at posttreatment as compared to a Placebo Control Task. Aim 2: Examine whether ABMT leads to significantly lower levels of anxiety as compared to a Placebo Control Task at a follow up evaluation eight weeks posttreatment. This would suggest the maintenance of ABMT effects after eight weeks of no treatment. Aim 3: Gain perspective on the viability of variables as potential mediators and moderator of ABMT so as to inform decisions about whether to pursue these variables in a future R01. The variables proposed as potential mediators are attention bias toward threat and threat-related interpretation bias. The variable proposed as a potential moderator is attention control. Overall, this project will provide critically needed data on ABMT as a treatment augment for youth with anxiety disorders who do not respond CBT. With these data in hand, the field will be in a better position to determine whether and how ABMT may be used optimally among anxious youth who are likely to need more than CBT.
Interventions
At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
Sponsors
Study design
Eligibility
Inclusion criteria
* 8-16 years old * completed a 12-14 week cognitive behavioral therapy for anxiety * a primary DSM-IV diagnosis of generalized anxiety disorder, social anxiety disorder, or separation anxiety disorder * if other psychiatric disorders are present, they must be treated with medication and stable
Exclusion criteria
* meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation * a high likelihood of harming self or others * not been living with a primary caregiver for at least 6 months who is legally able to give consent for the child's participation * previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services; * involved currently in another psychosocial/behavioral treatment * a serious vision problem that is not corrected with prescription lenses * a physical disability that interferes with the ability to click a mouse button rapidly and repeatedly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Rating on the Pediatric Anxiety Rating Scale | post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification) | The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screen for Child Anxiety Related Emotional Disorders - Parent Version | post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification) | The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity. |
| Screen for Child Anxiety Related Emotional Disorders - Child Version | post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification) | The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Attention Bias Modification Attention Bias Modification is a computer-based attention training program
Attention Bias Modification: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders. | 33 |
| Placebo Attention Task The Placebo Attention Task uses the same computer-based format and stimuli as the Attention Bias Modification Task, but does not train attention toward or away from stimuli.
Placebo Attention Task: At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability. | 31 |
| Total | 64 |
Baseline characteristics
| Characteristic | Attention Bias Modification | Placebo Attention Task | Total |
|---|---|---|---|
| Age, Continuous | 12.18 years STANDARD_DEVIATION 2.69 | 11.26 years STANDARD_DEVIATION 2.16 | 11.8 years STANDARD_DEVIATION 2.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 27 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pediatric Anxiety Rating Scale | 14.55 units on a scale STANDARD_DEVIATION 3.63 | 13.12 units on a scale STANDARD_DEVIATION 3.9 | 13.96 units on a scale STANDARD_DEVIATION 3.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 28 Participants | 27 Participants | 55 Participants |
| Screen for Child Anxiety and Related Emotional Disorders - Child Version | 23.03 units on a scale STANDARD_DEVIATION 12.81 | 22.87 units on a scale STANDARD_DEVIATION 15.65 | 22.99 units on a scale STANDARD_DEVIATION 14.92 |
| Screen for Child Anxiety and Related Emotional Disorders - Parent Version | 27.74 units on a scale STANDARD_DEVIATION 14.57 | 26.24 units on a scale STANDARD_DEVIATION 12.46 | 26.76 units on a scale STANDARD_DEVIATION 13.68 |
| Sex: Female, Male Female | 18 Participants | 12 Participants | 30 Participants |
| Sex: Female, Male Male | 15 Participants | 19 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 31 |
| other Total, other adverse events | 0 / 33 | 0 / 31 |
| serious Total, serious adverse events | 1 / 33 | 0 / 31 |
Outcome results
Clinician Rating on the Pediatric Anxiety Rating Scale
The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.
Time frame: 8-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Clinician Rating on the Pediatric Anxiety Rating Scale | 9.50 units on a scale | Standard Deviation 6.05 |
| Placebo Attention Task | Clinician Rating on the Pediatric Anxiety Rating Scale | 5.95 units on a scale | Standard Deviation 4.39 |
Clinician Rating on the Pediatric Anxiety Rating Scale
The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.
Time frame: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Clinician Rating on the Pediatric Anxiety Rating Scale | 8.88 units on a scale | Standard Deviation 5.64 |
| Placebo Attention Task | Clinician Rating on the Pediatric Anxiety Rating Scale | 8.12 units on a scale | Standard Deviation 5.03 |
Screen for Child Anxiety Related Emotional Disorders - Child Version
The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.
Time frame: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Screen for Child Anxiety Related Emotional Disorders - Child Version | 14.15 units on a scale | Standard Deviation 12.78 |
| Placebo Attention Task | Screen for Child Anxiety Related Emotional Disorders - Child Version | 12.83 units on a scale | Standard Deviation 13.6 |
Screen for Child Anxiety Related Emotional Disorders - Child Version
The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.
Time frame: 8-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Screen for Child Anxiety Related Emotional Disorders - Child Version | 17.75 units on a scale | Standard Deviation 16.45 |
| Placebo Attention Task | Screen for Child Anxiety Related Emotional Disorders - Child Version | 12.09 units on a scale | Standard Deviation 12.18 |
Screen for Child Anxiety Related Emotional Disorders - Parent Version
The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.
Time frame: post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Screen for Child Anxiety Related Emotional Disorders - Parent Version | 22.22 units on a scale | Standard Deviation 14.23 |
| Placebo Attention Task | Screen for Child Anxiety Related Emotional Disorders - Parent Version | 18.05 units on a scale | Standard Deviation 12.49 |
Screen for Child Anxiety Related Emotional Disorders - Parent Version
The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.
Time frame: 8-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Bias Modification | Screen for Child Anxiety Related Emotional Disorders - Parent Version | 21.05 units on a scale | Standard Deviation 14.12 |
| Placebo Attention Task | Screen for Child Anxiety Related Emotional Disorders - Parent Version | 17.98 units on a scale | Standard Deviation 13.16 |