NCT04271111

Brief Summary

This study assesses whether a computerized intervention can be used to decrease perceived hostility in hostile individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

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

March 25, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

March 25, 2019

Last Update Submit

August 6, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Changes in Cook Medley Hostility Inventory

    Self-report measure assessing hostility using a true/false scale with higher scores indicating higher levels of hostility.

    Baseline, one hour, one week, one month

  • Changes in Word Sentence Association Paradigm-Hostility

    Self-report measure assessing hostility using a 6-point scale with higher scores indicating higher levels of hostile interpretation bias.

    Baseline, one hour, one week, one month

  • Changes in Alcohol Use Disorders Identification Test

    Self-report measure assessing symptoms of alcohol use disorder with higher scores indicating more severe symptoms.

    Baseline, one hour, one week, one month

  • Changes in Drinking Motives Questionnaires

    Self-report measure assessing motives for drinking, including social, recreational, and coping. Higher scores indicate greater likelihood of drinking for each motive.

    Baseline, one hour, one week, one month

  • Changes in alcohol use

    Participants will provide the number of standard drinks of alcohol they drank each day in the past month.

    Baseline, one hour, one week, one month

Secondary Outcomes (2)

  • Changes in Self Stigma of Seeking Help

    Baseline, one hour, one week, one month

  • Changes in Perceived Stigma and Barriers to Care for Psychological Treatment

    Baseline, one hour, one week, one month

Study Arms (2)

Active treatment

EXPERIMENTAL

Computerized intervention aimed at reducing perceived hostility.

Behavioral: Online Treatment for Interpersonal Stress

Control condition

ACTIVE COMPARATOR

Computerized intervention aimed at increasing overall physical health.

Behavioral: Physical Health Education Tool

Interventions

Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships

Active treatment

Intervention designed to improve physical health through exercise, eating habits, and sleep

Control condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Increased hostility based on the Buss Perry Aggression Questionnaire

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know what condition they are assigned to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized into active treatment or control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

March 25, 2019

First Posted

February 17, 2020

Study Start

October 10, 2019

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations