- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04271111
Computerized Intervention for Interpersonal Stress
August 6, 2021 updated by: Brittany Mathes, Florida State University
This study assesses whether a computerized intervention can be used to decrease perceived hostility in hostile individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will investigate whether a brief computerized intervention can decrease perceived hostility of interpersonal situations.
Participants will be randomized into an active treatment or control condition.
We hypothesize that participants in the treatment condition will have lower perceived hostility at post treatment than those in the waitlist condition.
Study Type
Interventional
Enrollment (Actual)
111
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32304
- Florida State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Increased hostility based on the Buss Perry Aggression Questionnaire
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active treatment
Computerized intervention aimed at reducing perceived hostility.
|
Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships
|
|
Active Comparator: Control condition
Computerized intervention aimed at increasing overall physical health.
|
Intervention designed to improve physical health through exercise, eating habits, and sleep
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Cook Medley Hostility Inventory
Time Frame: Baseline, one hour, one week, one month
|
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
Time Frame: Baseline, one hour, one week, one month
|
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
Time Frame: Baseline, one hour, one week, one month
|
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
Time Frame: Baseline, one hour, one week, one month
|
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
Time Frame: Baseline, one hour, one week, one month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Self Stigma of Seeking Help
Time Frame: Baseline, one hour, one week, one month
|
Self-report measure assessing stigma associated with seeking help for psychological problems.
Higher scores indicate greater negative attitudes toward psychosocial treatment.
|
Baseline, one hour, one week, one month
|
|
Changes in Perceived Stigma and Barriers to Care for Psychological Treatment
Time Frame: Baseline, one hour, one week, one month
|
Self-report measure assessing stigma associated with seeking help for psychological problems.
Higher scores indicate greater negative attitudes toward psychosocial treatment.
|
Baseline, one hour, one week, one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2019
Primary Completion (Actual)
February 28, 2021
Study Completion (Actual)
February 28, 2021
Study Registration Dates
First Submitted
March 25, 2019
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
August 9, 2021
Last Update Submitted That Met QC Criteria
August 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2018.26213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hostility
-
Walter Reed Army Institute of Research (WRAIR)Enrolling by invitation
-
University of UtahTerminated
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Hostility
-
Massachusetts General HospitalBenson-Henry Institute for Mind Body MedicineCompletedDepression | Quality of Life | Stress | Atrial Fibrillation | Anxiety | HostilityUnited States
-
Universidad Internacional de ValenciaUniversity of ValenciaRecruitingDepression | Obsessive-Compulsive Disorder | Anxiety | Posttraumatic Stress Disorder | Dissociative Disorder | Hostility | SomatizationSpain
Clinical Trials on Online Treatment for Interpersonal Stress
-
Lea Nørgaard SørensenGødstrup HospitalRecruiting
-
University of PittsburghNational Institute of Mental Health (NIMH)CompletedEvaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With DepressionDepressionUnited States
-
VU University of AmsterdamCompleted
-
Hong Kong Baptist UniversityStockholm University; Research Grants Council, Hong KongCompletedPsychological DistressHong Kong
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)Completed
-
Celal Bayar UniversityCompletedAbused WomenTurkey (Türkiye)
-
Amasya UniversityCompletedThe Effect of Online Stress Management Program on Nurses' Individual Workload Perception, and StressStress | Nursing | Stress ManagementTurkey (Türkiye)
-
University Hospital, Basel, SwitzerlandSwiss National Science Foundation; Krebsforschung Schweiz, Bern, SwitzerlandCompletedCancer | Psychological DistressSwitzerland
-
Florida State UniversityCompletedPerfectionismUnited States