EmotionsNCT05730270
Effects of Smartphone-Based Stress Reduction Training on Social Relations
A study testing Stress reduction program 1 and Stress reduction program 2 in people with Emotions, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to find out how two different online stress reduction training programs affect people's daily experiences and social relations. The researchers think that people's thoughts, emotions, and behavior toward others may be influenced by stress reduction programs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotions
- What is being tested?
- Stress reduction program 1 and Stress reduction program 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 12 Apr 2024
- 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
- Virginia Commonwealth University students
- age 18 years or older
- Healthy
- English literate
- non-immigrant
- not practicing stress reduction techniques for more than 60 minutes a week
- ownership of a smartphone
Who cannot join
- People who are not Virginia Commonwealth University students
- major, uncorrected sensory impairments and cognitive deficits
- psychiatric disorders or history thereof
- new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
- current drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to find out how two different online stress reduction training programs affect people's daily experiences and social relations. The researchers think that people's thoughts, emotions, and behavior toward others may be influenced by stress reduction programs. This study will allow them to study the effectiveness of stress reduction programs for important real-world psychological outcomes.
- Conditions
- Emotions
- Being tested
- Stress reduction program 1, Stress reduction program 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress reduction program 1Behavioural
Participants will receive daily online lessons
Stress reduction program 2Behavioural
Participants will receive daily online lessons
| Study group | Role | What they receive |
|---|---|---|
| Stress reduction program 1 | Experimental | Participants will complete stress reduction lessons for two weeks Receives: Behavioral: Stress reduction program 1 |
| Stress reduction program 2 | Experimental | Participants will complete stress reduction lessons for two weeks Receives: Behavioral: Stress reduction program 2 |
| Waitlist | No intervention | Participants will have an opportunity to complete one of the two programs of stress reduction lessons after data collection is completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in state emotion regulation
Participants will complete a state emotion strategies measure which will ask them to check various actions they are taking to change their thoughts and feelings. Change in total number of actions checked will be calculated.
Measured: Baseline to post intervention, approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start30 Mar 2023
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730270
- Sponsor's protocol ID
- HM20021623
- Status last verified
- May 2024
- First submitted
- 6 Feb 2023
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smartphone-Based Stress Reduction Training on Social Relations
- ClinicalTrials.gov ID
- NCT05730270
- Acronym / sponsor ID
- HM20021623
- Conditions
- Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 15 Feb 2023 (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.
The purpose of this research study is to find out how two different online stress reduction training programs affect people's daily experiences and social relations. The researchers think that people's thoughts, emotions, and behavior toward others may be influenced by stress reduction programs. This study will allow them to study the effectiveness of stress reduction programs for important real-world psychological outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress reduction program 1 | Experimental | Behavioral: Stress reduction program 1Participants will complete stress reduction lessons for two weeks |
| Stress reduction program 2 | Experimental | Behavioral: Stress reduction program 2Participants will complete stress reduction lessons for two weeks |
| Waitlist | No intervention | –Participants will have an opportunity to complete one of the two programs of stress reduction lessons after data collection is completed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Virginia Commonwealth University students
- age 18 years or older
- Healthy
- English literate
- non-immigrant
Key exclusion criteria (5 listed)
- People who are not Virginia Commonwealth University students
- major, uncorrected sensory impairments and cognitive deficits
- psychiatric disorders or history thereof
- new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
- current drug abuse
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 |
|---|---|---|
| Stress reduction program 1Participants will receive daily online lessons | Behavioural | Stress reduction program 1 |
| Stress reduction program 2Participants will receive daily online lessons | Behavioural | Stress reduction program 2 |
Primary outcome
Change in state emotion regulation
Time frame: Baseline to post intervention, approximately 2 weeks
Participants will complete a state emotion strategies measure which will ask them to check various actions they are taking to change their thoughts and feelings. Change in total number of actions checked will be calculated.
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 29 May 2024.
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Healthy Adult Participants
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 Stress reduction program 1 and Stress reduction program 2 in people with Emotions, run by Virginia Commonwealth 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 7 inclusion and 5 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 29 May 2024. 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?
Change in state emotion regulation (time frame: Baseline to post intervention, approximately 2 weeks). 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 29 May 2024.