HostilityNCT04271111
Computerized Intervention for Interpersonal Stress
A study testing Online Treatment for Interpersonal Stress and Physical Health Education Tool in people with Hostility, run by Florida State University at 1 site in United States.
Trial summary
This study assesses whether a computerized intervention can be used to decrease perceived hostility in hostile individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hostility
- What is being tested?
- Online Treatment for Interpersonal Stress and Physical Health Education Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Increased hostility based on the Buss Perry Aggression Questionnaire
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
This study assesses whether a computerized intervention can be used to decrease perceived hostility in hostile individuals.
Read the 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.
- Conditions
- Hostility
- Being tested
- Online Treatment for Interpersonal Stress, Physical Health Education Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Treatment for Interpersonal StressBehavioural
Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships
Physical Health Education ToolBehavioural
Intervention designed to improve physical health through exercise, eating habits, and sleep
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Computerized intervention aimed at reducing perceived hostility. Receives: Behavioral: Online Treatment for Interpersonal Stress |
| Control condition | Active comparator | Computerized intervention aimed at increasing overall physical health. Receives: Behavioral: Physical Health Education Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cook Medley Hostility Inventory
Self-report measure assessing hostility using a true/false scale with higher scores indicating higher levels of hostility.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, one hour, one week, one month
Secondary outcomes (2)
Changes in Self Stigma of Seeking Help
Self-report measure assessing stigma associated with seeking help for psychological problems. Higher scores indicate greater negative attitudes toward psychosocial treatment.
Measured: Baseline, one hour, one week, one month
Changes in Perceived Stigma and Barriers to Care for Psychological Treatment
Self-report measure assessing stigma associated with seeking help for psychological problems. Higher scores indicate greater negative attitudes toward psychosocial treatment.
Measured: Baseline, one hour, one week, one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start10 Oct 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HostilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into active treatment or control condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittany Mathes, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271111
- Sponsor's protocol ID
- 2018.26213
- Other IDs
- 2018
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Intervention for Interpersonal Stress
- ClinicalTrials.gov ID
- NCT04271111
- Acronym / sponsor ID
- 2018.26213
- Conditions
- Hostility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses whether a computerized intervention can be used to decrease perceived hostility in hostile individuals.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized into active treatment or control condition.
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Behavioral: Online Treatment for Interpersonal StressComputerized intervention aimed at reducing perceived hostility. |
| Control condition | Active comparator | Behavioral: Physical Health Education ToolComputerized intervention aimed at increasing overall physical health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Increased hostility based on the Buss Perry Aggression Questionnaire
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Treatment for Interpersonal StressIntervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships | Behavioural | Active treatment |
| Physical Health Education ToolIntervention designed to improve physical health through exercise, eating habits, and sleep | Behavioural | Control condition |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Changes in Self Stigma of Seeking Help
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Treatment for Interpersonal Stress and Physical Health Education Tool in people with Hostility, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cook Medley Hostility Inventory (time frame: Baseline, one hour, one week, one month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.