Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07645131

Development of a Mobile Health Intervention to Support Functioning of Veterans With Substance Use Disorders

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location contact

Shannon Schrader, PhD

CONTACT

[email protected]

203-892-3624

Shannon Schrader, PhD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • current SUD diagnosis according to chart review
  • current enrollment in VACHS residential SUD treatment program
  • competent to provide written informed consent
  • a working smartphone with wireless capabilities or willingness to use a study-provided smartphone

Exclusion criteria

  • 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

Treatment and study plan

METS4Vets

Behavioral

Motivational Enhancement Therapy Skills for Veterans mobile app based intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Psychosocial functioning (Brief Inventory of Psychosocial Functioning)

    Time frame: Through 6-month follow-up

    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.

  2. Substance use

    Time frame: Through 6-month follow-up

    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).

  3. Sleep

    Time frame: Through 6-month follow-up

    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.

  4. Quality of Life (VR-12)

    Time frame: Through 6-month follow-up

    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.

  5. Quality of Life (VAS)

    Time frame: Through 6-month follow-up

    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.

  6. Substance Use (ASI)

    Time frame: Through 6-month follow-up

    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.

  7. Treatment engagement

    Time frame: Through 6-month follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon Schrader, PhD

CONTACT

[email protected]

(203) 892-3624

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.