Trial Outcomes & Findings for Hostile Bias Modification Training Online Study II (NCT NCT04015440)

Results Overview

Adapted from the "Angry Cognitions Scale" (Martin and Dahlen 2007). Volunteers read hypothetical scenarios where another person acted aggressively but with unclear intent (e.g., "You are driving through a residential area when someone backs their car out of a driveway and nearly hits you."). Volunteers respond to items (from "Very Unlikely" to "Very Likely") to indicate how they would think about the situation (e.g., "He/she did that just so I'd have to stop. He/she was trying to scare me."). Volunteers responded to one set (4 scenarios) at time point one and a second set (5 scenarios) at time point two. Reponses were summed within each scenario and averaged across scenarios to indicate level of hostile attribution bias. Individual scores at each time point could range from 0 (no hostile attribution bias) to 24 (high hostile attribution bias).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

229 participants

Primary outcome timeframe

24-96 hours post HBMT

Results posted on

2021-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	HBMT HBMT: Individual is presented with words with some letters missing and told to complete the word for form non-hostile words.	Placebo Alternative to HBMT training. Volunteers is presented with words with some letters missing and told to complete them with whatever comes to mind (no specific instructions).
Overall Study STARTED	117	112
Overall Study COMPLETED	109	108
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only volunteers who completed all measures were analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HBMT n=117 Participants HBMT: Individual is presented with words with some letters missing and told to complete the word.	Placebo n=112 Participants Other Training: Alternative to HBMT training	Total n=229 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 12.2 • n=109 Participants • Only volunteers who completed all measures were analyzed.	36.3 years STANDARD_DEVIATION 11.4 • n=108 Participants • Only volunteers who completed all measures were analyzed.	38.4 years STANDARD_DEVIATION 11.8 • n=217 Participants • Only volunteers who completed all measures were analyzed.
Sex: Female, Male Female	48 Participants n=109 Participants • Only volunteers who completed all measured wee analyzed/reported. Note: one volunteer refused to report sex.	49 Participants n=107 Participants • Only volunteers who completed all measured wee analyzed/reported. Note: one volunteer refused to report sex.	97 Participants n=216 Participants • Only volunteers who completed all measured wee analyzed/reported. Note: one volunteer refused to report sex.
Sex: Female, Male Male	61 Participants n=109 Participants • Only volunteers who completed all measured wee analyzed/reported. Note: one volunteer refused to report sex.	58 Participants n=107 Participants • Only volunteers who completed all measured wee analyzed/reported. Note: one volunteer refused to report sex.	119 Participants n=216 Participants • Only volunteers who completed all measured wee analyzed/reported. Note: one volunteer refused to report sex.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 24-96 hours post HBMT

Adapted from the "Angry Cognitions Scale" (Martin and Dahlen 2007). Volunteers read hypothetical scenarios where another person acted aggressively but with unclear intent (e.g., "You are driving through a residential area when someone backs their car out of a driveway and nearly hits you."). Volunteers respond to items (from "Very Unlikely" to "Very Likely") to indicate how they would think about the situation (e.g., "He/she did that just so I'd have to stop. He/she was trying to scare me."). Volunteers responded to one set (4 scenarios) at time point one and a second set (5 scenarios) at time point two. Reponses were summed within each scenario and averaged across scenarios to indicate level of hostile attribution bias. Individual scores at each time point could range from 0 (no hostile attribution bias) to 24 (high hostile attribution bias).

Outcome measures

Outcome measures
Measure	HBMT n=109 Participants HBMT: Individual is presented with words with some letters missing and told to complete the word for form non-hostile words.	Placebo n=108 Participants Alternative to HBMT training. Volunteers is presented with words with some letters missing and told to complete them with whatever comes to mind (no specific instructions).
Hostile Attribution Bias	9.4 score on a scale Standard Deviation 3.9	10.8 score on a scale Standard Deviation 3.9

PRIMARY outcome

Timeframe: 24-96 hours post HBMT

State Aggression Survey: This survey is adapted from several others in the literature to measure variance along the normal spectrum of aggressive behaviors in daily life that the average person might display (Álvarez-García, et al., 2016; Deffenbacher, et al., 2001; Deffenbacher, J. et al., 2002). The survey specifically asks about driving behaviors (e.g., yelling at other drivers). Scoring is count of aggressive behaviors during reporting period.

Outcome measures

Outcome measures
Measure	HBMT n=109 Participants HBMT: Individual is presented with words with some letters missing and told to complete the word for form non-hostile words.	Placebo n=108 Participants Alternative to HBMT training. Volunteers is presented with words with some letters missing and told to complete them with whatever comes to mind (no specific instructions).
Driving Aggression	3.0 Number of aggressive driving behaviors Standard Deviation 3.6	3.6 Number of aggressive driving behaviors Standard Deviation 3.9

PRIMARY outcome

Timeframe: 24-96 hours post treatment

Seven items adapted from the Cyber-Aggression Questionnaire for Adolescents by Álvarez-García et al. (2016). Volunteers reported at time point two how often (during preceding 24 h) they engaged in various aggressive online behaviors (e.g., posted rude comments about someone on a social network). Response choices ranged from 1 = never to 4 = always. Scores were recorded dichotomously to represent whether a volunteer reported any online aggression during the reporting period (i.e. "never" was recoded as "0" to indicate no aggression, and all other responses were recoded as "1" to indicate at least some aggression. A higher percentage of volunteers in a study condition reporting usage of aggression on social media indicates a worse outcome for that study condition.

Outcome measures

Outcome measures
Measure	HBMT n=109 Participants HBMT: Individual is presented with words with some letters missing and told to complete the word for form non-hostile words.	Placebo n=108 Participants Alternative to HBMT training. Volunteers is presented with words with some letters missing and told to complete them with whatever comes to mind (no specific instructions).
Aggression On Social Media	15 Participants	24 Participants

SECONDARY outcome

Timeframe: 24-96 hours post HBMT

Trait Anger Scale: Brief measure of trait anger validated by Wilk et al., (2015). Scale (1-5, strongly disagree to strongly agree); Two questions regarding individual's perspective on their anger. Higher values indicate greater anger.

Outcome measures

Outcome measures
Measure	HBMT n=109 Participants HBMT: Individual is presented with words with some letters missing and told to complete the word for form non-hostile words.	Placebo n=108 Participants Alternative to HBMT training. Volunteers is presented with words with some letters missing and told to complete them with whatever comes to mind (no specific instructions).
Anger	1.9 score on a scale Standard Deviation 1.1	1.7 score on a scale Standard Deviation .9

Adverse Events

HBMT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Jeffrey M Osgood, Ph.D. Associate Director of Military Psychiatry Branch

Walter Reed Army Institute of Research

Phone: 301-319-7475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place