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Not yet recruiting NCT07645131

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

No phase Interventional Substance Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: METS4Vets.
Who it may be relevant to
Registry conditions: Substance Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • Behavioral METS4Vets
    Motivational Enhancement Therapy Skills for Veterans mobile app based intervention

Primary outcome measures

  • Intervention Usability (Systems Usability Scale) [Time frame: Through 3-month follow-up assessment]
  • Intervention Acceptability (mHealth Satisfaction Questionnaire) [Time frame: Through 3-month follow-up assessment]
  • Study Feasibility (rates of attrition) [Time frame: Through 6-month follow-up assessment]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven

Identifiers

NCT: NCT07645131 · RRD9-008-25W · RD001916-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗