Trial Outcomes & Findings for Attention Bias Modification Training for Young People (NCT NCT02270671)
NCT ID: NCT02270671
Last Updated: 2018-11-20
Results Overview
The bias measurement protocol consists of 120 trials (80 angry-neutral and 40 neutral-neutral presentations). Angry face location, probe location, probe type and actor are all fully counterbalanced in presentation. The participant must perform with more than 70% accuracy on the first 10 trials.The threat bias measurement consisted of 120 trials of the dot-probe task, 80 of which contained angry-neutral face pairs and 40 of which contained neutral-neutral face pairs. The threat bias score equal the mean of neutral NT trials minus mean of threat NT trials. A threat bias scores \>0 indicate a bias towards threat, whereas scores \<0 mean that the participant is slower to respond to threatening stimuli than neutral stimuli. Reaction times were measured in milliseconds.
COMPLETED
NA
130 participants
Post-intervention (week 4), and 12-week follow-up
2018-11-20
Participant Flow
Approximately 2,900 students were invited to take part through Irish second-level schools. N=545 provided assent and parental consent. N=12 were excluded based on exclusion criteria and N=36 were absent for screening. N=497 completed screening of which N=130 met the inclusion criteria. Data were collected between September 2014 and May 2015.
Participant milestones
| Measure |
Placebo
The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
Placebo: Placebo Training
|
Intervention
The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
ABMT: Attention Bias Modification Training
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
66
|
|
Overall Study
COMPLETED
|
59
|
61
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Placebo
The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
Placebo: Placebo Training
|
Intervention
The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
ABMT: Attention Bias Modification Training
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Missed Post-intervention Data Collection
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Attention Bias Modification Training for Young People
Baseline characteristics by cohort
| Measure |
Placebo
n=59 Participants
The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
Placebo: Placebo Training
|
Intervention
n=61 Participants
The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
ABMT: Attention Bias Modification Training
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.97 years
STANDARD_DEVIATION .74 • n=5 Participants
|
15.93 years
STANDARD_DEVIATION .68 • n=7 Participants
|
15.95 years
STANDARD_DEVIATION .71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
59 participants
n=5 Participants
|
61 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Previously Used Mental Health Services
Yes
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Previously Used Mental Health Services
No
|
46 participants
n=5 Participants
|
53 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Threat Bias Measurement
|
4.01 milliseconds
STANDARD_DEVIATION 28.35 • n=5 Participants
|
-.06 milliseconds
STANDARD_DEVIATION 19.03 • n=7 Participants
|
1.94 milliseconds
STANDARD_DEVIATION 24.05 • n=5 Participants
|
|
Social Phobia and Anxiety
|
29.15 units on a scale
STANDARD_DEVIATION 7.47 • n=5 Participants
|
31.49 units on a scale
STANDARD_DEVIATION 7.53 • n=7 Participants
|
30.34 units on a scale
STANDARD_DEVIATION 7.56 • n=5 Participants
|
|
Fear of Negative Evaluation
|
31.29 units on a scale
STANDARD_DEVIATION 10.38 • n=5 Participants
|
31.80 units on a scale
STANDARD_DEVIATION 9.67 • n=7 Participants
|
31.55 units on a scale
STANDARD_DEVIATION 9.99 • n=5 Participants
|
|
Anxiety Related Disorders
|
36.05 units on a scale
STANDARD_DEVIATION 12.31 • n=5 Participants
|
39.46 units on a scale
STANDARD_DEVIATION 13.81 • n=7 Participants
|
37.78 units on a scale
STANDARD_DEVIATION 13.15 • n=5 Participants
|
|
Depression Symptoms
|
11.64 units on a scale
STANDARD_DEVIATION 5.99 • n=5 Participants
|
12.84 units on a scale
STANDARD_DEVIATION 7.31 • n=7 Participants
|
12.25 units on a scale
STANDARD_DEVIATION 6.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post-intervention (week 4), and 12-week follow-upThe bias measurement protocol consists of 120 trials (80 angry-neutral and 40 neutral-neutral presentations). Angry face location, probe location, probe type and actor are all fully counterbalanced in presentation. The participant must perform with more than 70% accuracy on the first 10 trials.The threat bias measurement consisted of 120 trials of the dot-probe task, 80 of which contained angry-neutral face pairs and 40 of which contained neutral-neutral face pairs. The threat bias score equal the mean of neutral NT trials minus mean of threat NT trials. A threat bias scores \>0 indicate a bias towards threat, whereas scores \<0 mean that the participant is slower to respond to threatening stimuli than neutral stimuli. Reaction times were measured in milliseconds.
Outcome measures
| Measure |
Placebo
n=59 Participants
The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
Placebo: Placebo Training
|
Intervention
n=61 Participants
The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
ABMT: Attention Bias Modification Training
|
|---|---|---|
|
Threat Bias Measurement at 4-week Post-intervention and 12-week Follow-up
Post-intervention
|
1.77 milliseconds
Standard Deviation 17.65
|
1.72 milliseconds
Standard Deviation 17.07
|
|
Threat Bias Measurement at 4-week Post-intervention and 12-week Follow-up
Follow-up
|
1.17 milliseconds
Standard Deviation 15.94
|
2.27 milliseconds
Standard Deviation 18.29
|
PRIMARY outcome
Timeframe: Post-intervention (week 4), and 12-week follow-upThe Social Phobia and Anxiety Inventory for Children (SPAI-C)(Beidel et al., 1998, 2000) is a 26-item, self-report measure exploring anxiety in social situations. Responses are indicated using a 3-point Likert scale from 0 = never or hardly ever to 2 = most of the time or always with scores ranging from 0-52. Higher scores on the SPAI-C represent higher levels of social anxiety.
Outcome measures
| Measure |
Placebo
n=59 Participants
The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
Placebo: Placebo Training
|
Intervention
n=61 Participants
The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
ABMT: Attention Bias Modification Training
|
|---|---|---|
|
Social Phobia and Anxiety at 4-week Post-intervention and 12-week Follow-up
Post-intervention
|
29.24 units on a scale
Standard Deviation 7.89
|
30.67 units on a scale
Standard Deviation 8.22
|
|
Social Phobia and Anxiety at 4-week Post-intervention and 12-week Follow-up
Follow-up
|
27.12 units on a scale
Standard Deviation 8.89
|
29.74 units on a scale
Standard Deviation 9.10
|
SECONDARY outcome
Timeframe: Post-intervention (week 4), and 12-week follow-upA 12-item self-report questionnaire to measure fear of negative evaluation - Brief Fear of Negative Evaluation Questionnaire -II (BFNE-II; Carleton et al., 2007). The BFNE-R (Carleton, McCreary, Norton, \& Asmundson, 2006) is a 12-item, revised version of the BFNE (Leary, 1983) used to elicit respondents' fear of negative evaluation. Responses are indicated using a 5-point Likert scale response format from 0 = not at all characteristics of me to 4 = entirely characteristic of me. Scores range from 0 to 48. Higher scores indicate higher fear of negative evaluation
Outcome measures
| Measure |
Placebo
n=59 Participants
The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
Placebo: Placebo Training
|
Intervention
n=61 Participants
The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
ABMT: Attention Bias Modification Training
|
|---|---|---|
|
Fear of Negative Evaluation at 4-week Post-Intervention and 12-week Follow-Up
Post-intervention
|
32.73 units on a scale
Standard Deviation 13.72
|
31.5 units on a scale
Standard Deviation 10.88
|
|
Fear of Negative Evaluation at 4-week Post-Intervention and 12-week Follow-Up
Follow-up
|
31.36 units on a scale
Standard Deviation 11.83
|
30.6 units on a scale
Standard Deviation 11.21
|
SECONDARY outcome
Timeframe: Post-intervention (week 4), and 12-week follow-upThe Screen for Child Anxiety Related Emotional Disorders (SCARED)(Birmaher et al., 1997) is a 41-item measure which has five subscales. Responses use a 3-point Likert scale, 0 = not true, or hardly ever true to 2 = very true or often true. The subscales are: Generalized Anxiety Disorder (GAD) (9 items, range 0-18); Panic Disorder (13 items, 0-26); Separation Anxiety Disorder (8 items, 0-16); and Social Phobia (7 items, 0-14), and School Avoidance (4 items, 0-8). Subscales are summed to provide a total score (range 0-82; while scores over 25 may be indicative of an anxiety disorder).
Outcome measures
| Measure |
Placebo
n=59 Participants
The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
Placebo: Placebo Training
|
Intervention
n=61 Participants
The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
ABMT: Attention Bias Modification Training
|
|---|---|---|
|
Anxiety Related Disorders at 4-week Post-intervention and 12-week Follow-up
Post-intervention
|
35.05 units on a scale
Standard Deviation 13.95
|
37.49 units on a scale
Standard Deviation 14.37
|
|
Anxiety Related Disorders at 4-week Post-intervention and 12-week Follow-up
Follow-up
|
33.71 units on a scale
Standard Deviation 14.78
|
35.41 units on a scale
Standard Deviation 14.59
|
SECONDARY outcome
Timeframe: Post-intervention (week 4), and 12-week follow-upThe Revised Child Anxiety and Depression Scale - Major Depressive Disorder (RCADS-MDD). The major depressive disorder subscale of the RCADS (Chorpita, Yim, Moffitt, Umemoto, \& Francis, 2000) is a 10-item subscale exploring symptoms of MDD as characterised by the DSM-IV, with on a 4-point Likert scale ranging from 0 = never to 3 = always. Scores range from 0 to 30. A score of 11 or higher has been shown to optimise sensitivity and specificity for the prediction of MDD (Ebesutani et al., 2012).
Outcome measures
| Measure |
Placebo
n=59 Participants
The placebo protocol consists of 160 trials (120 angry-neutral face pair and 40 neutral-neutral face pair presentations). In this condition, angry-face location, probe location and actor are fully counterbalanced in presentation. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
Placebo: Placebo Training
|
Intervention
n=61 Participants
The attention bias modification training (ABMT) protocol consists of 160 trials (120 angry-neutral face pair presentations and 40 neutral-neutral face pair presentations). In the ABM condition, the target-probe appears at the neutral-face locations in all angry-neutral trials. A short break is delivered every 40 trials (1 block). An accuracy of 70% or above for each block is necessary to continue training. The task takes 7 minutes.
ABMT: Attention Bias Modification Training
|
|---|---|---|
|
Depression Symptoms at 4-week Post-intervention and 12-week Follow-up
Post-intervention
|
12.71 units on a scale
Standard Deviation 6.23
|
13.30 units on a scale
Standard Deviation 7.78
|
|
Depression Symptoms at 4-week Post-intervention and 12-week Follow-up
Follow-up
|
11.88 units on a scale
Standard Deviation 6.86
|
12.57 units on a scale
Standard Deviation 7.76
|
Adverse Events
Placebo
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place