NCT04997356

Brief Summary

The primary objective of the present protocol is to evaluate the effectiveness of real HBMT versus placebo on reducing HAB and aggression. The secondary objectives of the present protocol are:

  1. 1.Investigate the role of individual difference variables on HAB, interpersonal aggression, and effects of HBMT.
  2. 2.Collect vocal recording data to inform the development of algorithms to predict emotional stress from changes in speech.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 12, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

July 29, 2021

Last Update Submit

December 14, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Essay Feedback Questionnaire

    8-item self-reported hostile attribution bias to ambiguously hostile or unambiguously hostile feedback (0-4). Higher scores indicate more bias.

    average of 30 minutes post-intervention

  • Taylor Aggression Paradigm (TAP)

    The TAP objectively elicits and measures participant's aggression in response to provocation from an opponent. Aggression is operationalized as setting higher volumes and/or longer durations for tones (0-10). Higher scores indicate more aggression.

    average of 45 minutes post-intervention

Study Arms (4)

Hostile Bias Modification (HBM) Training plus Unambiguous Feedback

EXPERIMENTAL

Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They are instructed not to respond if only an aggressive word can be formed. They will receive unambiguously hostile feedback to an essay.

Behavioral: Hostile Bias Modification Training

Other training plus Unambiguous Feedback

PLACEBO COMPARATOR

Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words. They will receive unambiguously hostile feedback to an essay.

Behavioral: Other training

Hostile Bias Modification (HBM) Training plus Ambiguous Feedback

EXPERIMENTAL

Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They are instructed not to respond if only an aggressive word can be formed. They will receive ambiguously hostile feedback to an essay.

Behavioral: Hostile Bias Modification Training

Other training plus Ambiguous Feedback

PLACEBO COMPARATOR

Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words. They will receive ambiguously hostile feedback to an essay.

Behavioral: Other training

Interventions

Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They will refrain from making words that can only form aggressive words.

Also known as: HBMT
Hostile Bias Modification (HBM) Training plus Ambiguous FeedbackHostile Bias Modification (HBM) Training plus Unambiguous Feedback
Other trainingBEHAVIORAL

Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words.

Other training plus Ambiguous FeedbackOther training plus Unambiguous Feedback

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male or female, ages 18-39 (inclusive)
  • Must confirm when asked by the experimenter that they are of normal hearing without the use of a hearing aid or have been diagnosed with any condition that produces a strong sensitivity to sound (e.g., misophonia, hyperacusis) to the best of their knowledge.
  • Must be able to provide written informed consent before commencing with experimental procedures and perform experimental writing and reading tasks (i.e., must be able to fluently read/write in English).
  • Must demonstrate satisfactory comprehension of the Informed Consent Document (ICD) by achieving a score of 100% correct on a short multiple-choice quiz .

You may not qualify if:

  • not between ages 18-39
  • not able to read/write fluently in English
  • not of normal hearing without use of a hearing aid
  • have been diagnosed with any condition that produces a strong sensitivity to sound (e.g., misophonia, hyperacusis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Margeaux V Auslander, PhD

    Walter Reed Army Institute of Research (WRAIR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded to study condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 9, 2021

Study Start

August 12, 2021

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations