Trial Outcomes & Findings for Attention-Bias Modification Treatment for PTSD (NCT NCT01888653)
NCT ID: NCT01888653
Last Updated: 2022-04-13
Results Overview
Measures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
4 weeks
Results posted on
2022-04-13
Participant Flow
Participant milestones
| Measure |
Comparison-Training-Program
Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes
Attention control training (ACT): In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.
|
Attention Biased Modification
Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.
Attention Bias Modification (ABM): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contingent on the bias measure.
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|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Comparison-Training-Program
n=24 Participants
Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes
Attention control training (ACT): In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.
|
Attention Biased Modification
n=26 Participants
Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.
Attention Bias Modification (ABM): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contingent on the bias measure.
|
Total
n=50 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=24 Participants
|
26 Participants
n=26 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
37.21 years
STANDARD_DEVIATION 10.29 • n=24 Participants
|
34.27 years
STANDARD_DEVIATION 10.15 • n=26 Participants
|
35.68 years
STANDARD_DEVIATION 10.22 • n=50 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=24 Participants
|
17 Participants
n=26 Participants
|
31 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=24 Participants
|
9 Participants
n=26 Participants
|
19 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
26 participants
n=26 Participants
|
50 participants
n=50 Participants
|
|
Clinician-Administered PTSD Scale (CAPS)
|
65.00 units on a scale
STANDARD_DEVIATION 12.08 • n=24 Participants
|
62.23 units on a scale
STANDARD_DEVIATION 10.39 • n=26 Participants
|
63.56 units on a scale
STANDARD_DEVIATION 11.21 • n=50 Participants
|
|
Hamilton Rating Scale for Depression (HRSD)
|
13.00 units on a scale
STANDARD_DEVIATION 4.82 • n=24 Participants
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11.77 units on a scale
STANDARD_DEVIATION 5.18 • n=26 Participants
|
12.36 units on a scale
STANDARD_DEVIATION 5.00 • n=50 Participants
|
|
PTSD Checklist Civilian Version (PCL-C)
|
62.12 units on a scale
STANDARD_DEVIATION 11.16 • n=24 Participants
|
57.31 units on a scale
STANDARD_DEVIATION 9.66 • n=26 Participants
|
59.62 units on a scale
STANDARD_DEVIATION 10.58 • n=50 Participants
|
|
Beck Depression Inventory-II (BDI-II)
|
25.87 units on a scale
STANDARD_DEVIATION 11.34 • n=24 Participants
|
24.58 units on a scale
STANDARD_DEVIATION 12.36 • n=26 Participants
|
25.20 units on a scale
STANDARD_DEVIATION 11.78 • n=50 Participants
|
PRIMARY outcome
Timeframe: 4 weeksMeasures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Outcome measures
| Measure |
Comparison-Training-Program
n=24 Participants
Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes
Attention control training (ACT): In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.
|
Attention Biased Modification
n=26 Participants
Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.
Attention Bias Modification (ABM): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contingent on the bias measure.
|
|---|---|---|
|
Primary Outcome: Clinician Administered PTSD Scale (CAPS)
|
26.44 units on a scale
Standard Deviation 16.09
|
15.96 units on a scale
Standard Deviation 15.75
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SECONDARY outcome
Timeframe: 4 weeksMeasures severity of posttraumatic stress disorder symptoms from 0 (least severe) to 80 (most severe).
Outcome measures
| Measure |
Comparison-Training-Program
n=24 Participants
Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes
Attention control training (ACT): In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.
|
Attention Biased Modification
n=26 Participants
Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.
Attention Bias Modification (ABM): The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contingent on the bias measure.
|
|---|---|---|
|
Secondary Outcome: PTSD Check List-Civilian (PCL-C)
|
20.22 units on a scale
Standard Deviation 15.07
|
7.84 units on a scale
Standard Deviation 10.24
|
Adverse Events
Comparison-Training-Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Biased Modification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Yuval Neria
Columbia University Medical Center/New York State Psychiatric Institute
Phone: 6467748092
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place