Trial Outcomes & Findings for Using Attentional Bias Modification to Address Trauma Symptoms (NCT NCT02615717)

Last Updated: 2017-02-03

Results Overview

Assesses symptoms and severity of Posttraumatic Stress Disorder Range: 0-80; total score utilized. Higher values indicate higher severity Subscales are summed to create a total score; subscales made up of different facets of PTSD.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

within three days

Results posted on

2017-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Attentional Bias Modification In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word). Attention Bias Modification: comparison of treatment versus control	Attentional Control Condition Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc. Attention Bias Modification: comparison of treatment versus control
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Attentional Bias Modification to Address Trauma Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Attentional Bias Modification n=3 Participants In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word). Attention Bias Modification: comparison of treatment versus control	Attentional Control Condition n=3 Participants Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc. Attention Bias Modification: comparison of treatment versus control	Total n=6 Participants Total of all reporting groups
Age, Continuous	19.7 years STANDARD_DEVIATION 1.2 • n=5 Participants	21.7 years STANDARD_DEVIATION 2.9 • n=7 Participants	20.7 years STANDARD_DEVIATION 2.2 • n=5 Participants
Gender Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: within three days

Outcome measures

Outcome measures
Measure	Attentional Bias Modification n=3 Participants In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word). Attention Bias Modification: comparison of treatment versus control	Attentional Control Condition n=3 Participants Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc. Attention Bias Modification: comparison of treatment versus control
Clinician-Administered PTSD Scale (CAPS-5)	10.3 units on a scale Standard Deviation 10.2	10.0 units on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: within three days

Self-report of PTSD symptom severity Scale range: 0-80 Total score utilized, all items summed. Higher score indicates higher severity.

Outcome measures

Outcome measures
Measure	Attentional Bias Modification n=3 Participants In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word). Attention Bias Modification: comparison of treatment versus control	Attentional Control Condition n=3 Participants Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc. Attention Bias Modification: comparison of treatment versus control
PTSD Checklist (PCL-5)	11.0 units on a scale Standard Deviation 8.2	10.0 units on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: within three days

Self-report measure of 9 symptoms related to depression Range: 0-27, all items summed Higher score indicates higher severity

Outcome measures

Outcome measures
Measure	Attentional Bias Modification n=3 Participants In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word). Attention Bias Modification: comparison of treatment versus control	Attentional Control Condition n=3 Participants Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc. Attention Bias Modification: comparison of treatment versus control
Patient Health Questionnaire (PHQ-9)	5.3 units on a scale Standard Deviation 3.8	6.7 units on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: within three days

Self-report measure of 20 symptoms of anxiety Range: 0-60 all items summed Higher score indicates higher severity

Outcome measures

Outcome measures
Measure	Attentional Bias Modification n=3 Participants In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word). Attention Bias Modification: comparison of treatment versus control	Attentional Control Condition n=3 Participants Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc. Attention Bias Modification: comparison of treatment versus control
Beck Anxiety Inventory (BAI)	29.0 units on a scale Standard Deviation 7.9	29.0 units on a scale Standard Deviation 6.0

Adverse Events

Attentional Bias Modification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attentional Control Condition

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

Christina Hein, M.A.

University of Nebraska, Lincoln

Phone: 7036184722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place