NCT07645131

Brief 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. The intervention will aim to support Veterans who are navigating the critical transition from structured residential substance use treatment to outpatient settings.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
61mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2031

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

5 years

First QC Date

June 2, 2026

Last Update Submit

June 8, 2026

Conditions

Substance Use

Keywords

Substance usemHealthFunctioningVeterans

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Through 6-month follow-up assessment

Secondary Outcomes (7)

  • Psychosocial functioning (Brief Inventory of Psychosocial Functioning)

    Through 6-month follow-up

  • Substance use

    Through 6-month follow-up

  • Sleep

    Through 6-month follow-up

  • Quality of Life (VR-12)

    Through 6-month follow-up

  • Quality of Life (VAS)

    Through 6-month follow-up

  • +2 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention condition

Behavioral: METS4Vets

Interventions

METS4VetsBEHAVIORAL

Motivational Enhancement Therapy Skills for Veterans mobile app based intervention

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Shannon Schrader, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Schrader, PhD

CONTACT

(203) 892-3624shannon.schrader@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm open pilot trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 12, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2031

Study Completion (Estimated)

September 30, 2031

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)