MVP RCT: Mind and Voice Project Randomized Control Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04018807|
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Physical Health Mental Health Alcohol; Use, Problem Interpersonal Violence||Other: Resource pamphlet Behavioral: Remote Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MVP RCT: Mind and Voice Project Randomized Control Trial|
|Actual Study Start Date :||July 22, 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||July 2020|
Participants will receive a pamphlet detailing mental health and social service providers at the local, state, and national level.
Other: Resource pamphlet
The pamphlet will list violence prevention, mental health, and substance abuse services.
Experimental: Remote Therapy
Participants will receive eight 30-minute remote therapy sessions over the course of twelve weeks.
Behavioral: Remote Therapy
Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018807
|Contact: Mandilyn Grahamfirstname.lastname@example.org|
|United States, Michigan|
|Hurley Medical Center||Recruiting|
|Flint, Michigan, United States, 48503|
|Contact: Mandilyn Graham 773-301-3640 email@example.com|
|Principal Investigator:||Quyen Ngo, PhD||University of Michigan|