Substance UseNCT07645131
Development of a Mobile Health Intervention to Support Functioning of Veterans With Substance Use Disorders
A study testing METS4Vets in people with Substance Use, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This project will involve the development, refinement, and preliminary testing of a mobile health intervention (Motivational Enhancement Therapy Skills for Veterans; "METS4Vets"), which will be delivered through a smartphone app. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- METS4Vets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 30 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- current Substance Use Disorder (SUD) diagnosis according to chart review
- current enrollment in VACHS residential Substance Use Disorder (SUD) treatment program
- competent to provide written informed consent
- a working smartphone with wireless capabilities or willingness to use a study-provided smartphone
Who cannot join
- current psychosis
- current active suicidal/homicidal ideation
- physical disability (e.g., uncorrected vision) that would preclude use of smartphones and/or smartphone applications
- cognitive impairment that would interfere with study participation or ability to provide informed consent, as determined by clinical interview
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Shannon Schrader, PhD, (203) 892-3624, shannon.schrader@va.gov
Shannon Schrader, PhD
About this study
This project will involve the development, refinement, and preliminary testing of a mobile health intervention (Motivational Enhancement Therapy Skills for Veterans; "METS4Vets"), which will be delivered through a smartphone app. The intervention will aim to support Veterans who are navigating the critical transition from structured residential substance use treatment to outpatient settings.
Read the detailed description
This project will involve the development, refinement, and pilot testing of a beta version of a mobile health intervention (Motivational Enhancement Therapy Skills for Veterans; "METS4Vets"), which will be delivered through a smartphone app.
Phase I: Preliminary METS4Vets content will be developed by the research team. Content will be developed by integrating research literature on digital interventions, evidence-based skills content derived from Motivational Enhancement Therapy, the "spirit" of Motivational Interviewing (e.g., using non-judgmental phrasing), and VA's existing My Recovery Plan framework. After preliminary content is developed, the research team will then solicit feedback on the proposed content through qualitative interviews with Veterans engaged in residential substance use treatment programming at VA (n=10) and VA clinicians who treat Veterans with substance use disorders (n=10).
Phase II: Using the content developed in Phase I, the investigators will conduct iterative, single session system acceptability and usability testing with Veterans engaged in residential substance use treatment programming at VA (n=12-15).
- Conditions
- Substance Use
- Being tested
- METS4Vets
- Keywords
- Substance use, mHealth, Functioning, Veterans
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METS4VetsBehavioural
Motivational Enhancement Therapy Skills for Veterans mobile app based intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention condition Receives: Behavioral: METS4Vets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Usability (Systems Usability Scale)
The Systems Usability Scale (SUS) will be used to assess the perceived usability of the intervention. The SUS is a 10-item Likert-type self-report measure that generates a subjective score to assess whether the system is sufficiently usable in its current form. Responses range from 0 to 4 with a total score ranging from 0 - 100. A score above 68 is considered above average while scores above 80 are considered highly favorable and indicative of recommending the product to friends.
Measured: Through 3-month follow-up assessment
Intervention Acceptability (mHealth Satisfaction Questionnaire)
The mHealth Satisfaction Questionnaire will be used to assess acceptability of the intervention. The mHealth Satisfaction Questionnaire is a 14-item self-report measure that assesses the level of user satisfaction and acceptability with the app, its interface, and its content. Responses range from 1 (strongly disagree) to 5 (strongly agree) Higher scores reflect greater satisfaction. Total scores can range from 14 to 70.
Measured: Through 3-month follow-up assessment
Study Feasibility (rates of attrition)
The rate of participant attrition across the total study period. Rates could potentially range from 0%-100% with higher attrition rates representing worse feasibility.
Measured: Through 6-month follow-up assessment
Secondary outcomes (7)
Psychosocial functioning (Brief Inventory of Psychosocial Functioning)
Changes from pre-intervention to 6 month follow-up in self-reported psychosocial functioning will be assessed via the Brief Inventory of Psychosocial Functioning (B-IPF), which is a 7-item scale with each item ranging from 0 ("not at all") to 6 ("very much"). Total scores can range from 0 to 42 with higher scores indicating worse psychosocial functioning. The B-IPF assesses different domains of psychosocial functioning including social functioning, occupational functioning, and participation in daily tasks.
Measured: Through 6-month follow-up
Substance use
Changes from pre-intervention to 6-month follow-up in self-reported substance use including frequency and quantity of alcohol use and frequency of drug use. This will be collected by asking Veterans (yes/no) whether they drank alcohol or used any illicit substances in the past 24 hours. For Veterans who endorse alcohol use, they will be asked how many standard drinks they consumed. For Veterans who respond affirmatively to illicit substance use, they will be asked to indicate which substance(s) they used (e.g., cannabis, cocaine, heroin).
Measured: Through 6-month follow-up
Sleep
Changes from pre-intervention to 6-month follow-up in self-reported sleep quality. This will be assessed by asking Veterans to 1) rate their perceived sleep quality on a 0 ("extremely poor") to 8 ("extremely rested") Likert-type scale; total scores can range from 0 to 8 with higher scores representing better subjective sleep quality; and 2) indicate how many hours of sleep they got on an average night in the assessment timeframe period.
Measured: Through 6-month follow-up
Quality of Life (VR-12)
Changes from pre-intervention to 6-month follow-up in self-reported quality of life assessed via the Veterans RAND 12-Item Health Survey (VR-12), which assesses health-related quality of life including domains of physical functioning, bodily pain, and social functioning. The VR-12 consists of 12 items on a 5-point Likert scale (0 to 5) with higher scores representing better quality of life. Total scores can range from 0 to 60.
Measured: Through 6-month follow-up
Quality of Life (VAS)
Changes from pre-intervention to 6-month follow-up in self-reported quality of life assessed via a single-item Visual Analog Scale (VAS). The VAS asks respondents to rate their global quality of life on a scale from 0 ("worst possible quality of life") to 100 ("best possible quality of life"). Total scores can range from 0 to 100 with higher scores representing better quality of life.
Measured: Through 6-month follow-up
Substance Use (ASI)
Changes from pre-intervention to 6-month follow-up in substance use will be assessed using the Addiction Severity Index (ASI). The ASI queries about seven potential problem areas impacted by substance use. Scores on the seven domains can range from 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. Total scores can range from 0 to 49 with higher scores representing worse substance use severity.
Measured: Through 6-month follow-up
Treatment engagement
Changes from pre-intervention to 6-month follow-up in self-reported treatment engagement. This will be collected by asking Veterans (yes/no) whether they attended any treatment appointments in the follow-up assessment timeframe including self-help groups (AA, NA), VA appointments, or community-based appointments.
Measured: Through 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jun 2027 (estimated)
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm open pilot trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shannon Schrader, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645131
- Sponsor's protocol ID
- RRD9-008-25W
- Other IDs
- RD001916-01A1
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Oct 2026
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mobile Health Intervention to Support Functioning of Veterans With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07645131
- Acronym / sponsor ID
- RRD9-008-25W
- Conditions
- Substance Use
- Keywords
- Substance use, mHealth, Functioning, Veterans
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 12 Jun 2026 (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 project will involve the development, refinement, and preliminary testing of a mobile health intervention (Motivational Enhancement Therapy Skills for Veterans; "METS4Vets"), which will be delivered through a smartphone app. The intervention will aim to support Veterans who are navigating the critical transition from structured residential substance use treatment to outpatient settings.
Detailed description
This project will involve the development, refinement, and pilot testing of a beta version of a mobile health intervention (Motivational Enhancement Therapy Skills for Veterans; "METS4Vets"), which will be delivered through a smartphone app.
Phase I: Preliminary METS4Vets content will be developed by the research team. Content will be developed by integrating research literature on digital interventions, evidence-based skills content derived from Motivational Enhancement Therapy, the "spirit" of Motivational Interviewing (e.g., using non-judgmental phrasing), and VA's existing My Recovery Plan framework. After preliminary content is developed, the research team will then solicit feedback on the proposed content through qualitative interviews with Veterans engaged in residential substance use treatment programming at VA (n=10) and VA clinicians who treat Veterans with substance use disorders (n=10).
Phase II: Using the content developed in Phase I, the investigators will conduct iterative, single session system acceptability and usability testing with Veterans engaged in residential substance use treatment programming at VA (n=12-15).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm open pilot trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: METS4VetsIntervention condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- current Substance Use Disorder (SUD) diagnosis according to chart review
- current enrollment in VACHS residential Substance Use Disorder (SUD) treatment program
- competent to provide written informed consent
- a working smartphone with wireless capabilities or willingness to use a study-provided smartphone
Key exclusion criteria (4 listed)
- current psychosis
- current active suicidal/homicidal ideation
- physical disability (e.g., uncorrected vision) that would preclude use of smartphones and/or smartphone applications
- cognitive impairment that would interfere with study participation or ability to provide informed consent, as determined by clinical interview
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 |
|---|---|---|
| METS4VetsMotivational Enhancement Therapy Skills for Veterans mobile app based intervention | Behavioural | Intervention |
Primary outcome
Intervention Usability (Systems Usability Scale)
Time frame: Through 3-month follow-up assessment
The Systems Usability Scale (SUS) will be used to assess the perceived usability of the intervention. The SUS is a 10-item Likert-type self-report measure that generates a subjective score to assess whether the system is sufficiently usable in its current form. Responses range from 0 to 4 with a total score ranging from 0 - 100. A score above 68 is considered above average while scores above 80 are considered highly favorable and indicative of recommending the product to friends.
Intervention Acceptability (mHealth Satisfaction Questionnaire)
Time frame: Through 3-month follow-up assessment
The mHealth Satisfaction Questionnaire will be used to assess acceptability of the intervention. The mHealth Satisfaction Questionnaire is a 14-item self-report measure that assesses the level of user satisfaction and acceptability with the app, its interface, and its content. Responses range from 1 (strongly disagree) to 5 (strongly agree) Higher scores reflect greater satisfaction. Total scores can range from 14 to 70.
Study Feasibility (rates of attrition)
Time frame: Through 6-month follow-up assessment
The rate of participant attrition across the total study period. Rates could potentially range from 0%-100% with higher attrition rates representing worse feasibility.
7 secondary outcomes
Psychosocial functioning (Brief Inventory of Psychosocial Functioning)
Time frame: Through 6-month follow-up
Substance use
Time frame: Through 6-month follow-up
Sleep
Time frame: Through 6-month follow-up
Quality of Life (VR-12)
Time frame: Through 6-month follow-up
Quality of Life (VAS)
Time frame: Through 6-month follow-up
Substance Use (ASI)
Time frame: Through 6-month follow-up
Treatment engagement
Time frame: Through 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Healthy Volunteers
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.
Shannon Schrader, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing METS4Vets in people with Substance Use, run by VA Office of Research and Development 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Schrader, PhD ((203) 892-3624, shannon.schrader@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Usability (Systems Usability Scale) (time frame: Through 3-month follow-up assessment). 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 5 Oct 2026.