Physical HealthNCT04018807
MVP RCT: Mind and Voice Project Randomized Control Trial
A study testing Resource pamphlet and Remote Therapy in people with Physical Health and Mental Health, run by University of Michigan at 1 site in United States.
Trial summary
The study seeks to learn more about the health behaviors of young adults. Health behaviors include relationships, physical and mental health, alcohol use, and conflicts with others. The purpose of this study is to improve prevention and intervention programs for young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Health, Mental Health, Alcohol; Use, Problem
- What is being tested?
- Resource pamphlet and Remote Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 31 Jul 2020
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prior Alcohol Use
- Interpersonal Violence
Who cannot join
- Person does not understand/speak English
- Prisoner or person being taken into custody/under house arrest
- Person or parent/guardian unable to give consent due to insufficient cognitive orientation due to unknown reasons
- Person unable to give consent due to insufficient cognitive orientation due to drug or alcohol use/ accidental overdose; given pain medications (fails MMSE)
- Person diagnosed with schizophrenia
- Person is actively suicidal or being treated for self-harm (includes overdose with the intent to harm self - not accidental)
Show all 13Show fewer
- Person being treated for child abuse situation
- Deaf or visually impaired/illiterate/can't speak
- Screened within last month or already in study
- Combative
- Patient died
- Too sick in emergency department to approach (e.g. - never stabilizes, in trauma bay, intubated, on ventilator, or a Level 1 trauma)
- Person has already refused 2 times
Trial locations and contacts
1 site in 1 country.
About this study
The study seeks to learn more about the health behaviors of young adults. Health behaviors include relationships, physical and mental health, alcohol use, and conflicts with others. The purpose of this study is to improve prevention and intervention programs for young adults.
- Being tested
- Resource pamphlet, Remote Therapy
- Medical subject headings
- Psychological Well-Being, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource pamphletOther
The pamphlet will list violence prevention, mental health, and substance abuse services.
Remote TherapyBehavioural
Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.
| Study group | Role | What they receive |
|---|---|---|
| Resource Pamphlet | Other | Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level. Receives: Other: Resource pamphlet |
| Remote Therapy | Experimental | Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks. Receives: Behavioral: Remote Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as Measured by Number of Sessions Completed
At least 80% of session content completed.
Measured: 12 weeks
Acceptability, as Measured by Client Satisfaction
Client satisfaction is measured by the Client Satisfaction Questionnaire Exit-8, an 8 question survey where a high score indicates client satisfaction.
Measured: 12 weeks
Usability, as Measured by a Modified Systems Usability Scale
System usability is measured by an adapted version of the Systems Usability Scale for the platform used.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start22 Jul 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical HealthStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Quyen Ngo, University of Michigan
- Investigators
- Quyen Ngo, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018807
- Sponsor's protocol ID
- HUM00155614
- Other IDs
- 5K23AA022641-05
- Status last verified
- Dec 2022
- First submitted
- 9 Jul 2019
- Last updated
- 12 Dec 2022
- Results posted
- 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 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MVP RCT: Mind and Voice Project Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04018807
- Acronym / sponsor ID
- HUM00155614
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Jul 2019 (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 study seeks to learn more about the health behaviors of young adults. Health behaviors include relationships, physical and mental health, alcohol use, and conflicts with others. The purpose of this study is to improve prevention and intervention programs for young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resource Pamphlet | Other | Other: Resource pamphletParticipants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level. |
| Remote Therapy | Experimental | Behavioral: Remote TherapyParticipants will receive eight 30-minute remote therapy sessions over the course of twelve weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Prior Alcohol Use
- Interpersonal Violence
Key exclusion criteria (13 listed)
- Person does not understand/speak English
- Prisoner or person being taken into custody/under house arrest
- Person or parent/guardian unable to give consent due to insufficient cognitive orientation due to unknown reasons
- Person unable to give consent due to insufficient cognitive orientation due to drug or alcohol use/ accidental overdose; given pain medications (fails MMSE)
- Person diagnosed with schizophrenia
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 |
|---|---|---|
| Resource pamphletThe pamphlet will list violence prevention, mental health, and substance abuse services. | Other | Resource Pamphlet |
| Remote TherapyRemote therapy sessions will include mindfulness exercises and motivational interviewing techniques. | Behavioural | Remote Therapy |
Primary outcome
Feasibility, as Measured by Number of Sessions Completed
Time frame: 12 weeks
At least 80% of session content completed.
Acceptability, as Measured by Client Satisfaction
Time frame: 12 weeks
Client satisfaction is measured by the Client Satisfaction Questionnaire Exit-8, an 8 question survey where a high score indicates client satisfaction.
Usability, as Measured by a Modified Systems Usability Scale
Time frame: 12 weeks
System usability is measured by an adapted version of the Systems Usability Scale for the platform used.
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 12 Dec 2022.
- 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.
Quyen Ngo, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resource pamphlet and Remote Therapy in people with Physical Health and Mental Health, run by University of Michigan 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 2 inclusion and 13 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 12 Dec 2022. 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?
Feasibility, as Measured by Number of Sessions Completed (time frame: 12 weeks). The study lists 3 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 12 Dec 2022.