Development of a Mobile Health Intervention to Support Functioning of Veterans With Substance Use Disorders
8. juni 2026 oppdatert av: VA Office of Research and Development
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shannon Schrader, PhD
- Telefonnummer: (203) 892-3624
- E-post: shannon.schrader@va.gov
Studiesteder
-
-
Connecticut
-
West Haven, Connecticut, Forente stater, 06516-2770
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
-
Ta kontakt med:
- Shannon Schrader, PhD
- Telefonnummer: 203-892-3624
- E-post: shannon.schrader@va.gov
-
Hovedetterforsker:
- Shannon Schrader, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention
Intervention condition
|
Motivational Enhancement Therapy Skills for Veterans mobile app based intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intervention Usability (Systems Usability Scale)
Tidsramme: 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.
|
Through 3-month follow-up assessment
|
|
Intervention Acceptability (mHealth Satisfaction Questionnaire)
Tidsramme: 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.
|
Through 3-month follow-up assessment
|
|
Study Feasibility (rates of attrition)
Tidsramme: 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.
|
Through 6-month follow-up assessment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Psychosocial functioning (Brief Inventory of Psychosocial Functioning)
Tidsramme: 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.
|
Through 6-month follow-up
|
|
Substance use
Tidsramme: 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).
|
Through 6-month follow-up
|
|
Sleep
Tidsramme: 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.
|
Through 6-month follow-up
|
|
Quality of Life (VR-12)
Tidsramme: 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.
|
Through 6-month follow-up
|
|
Quality of Life (VAS)
Tidsramme: 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.
|
Through 6-month follow-up
|
|
Substance Use (ASI)
Tidsramme: 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.
|
Through 6-month follow-up
|
|
Treatment engagement
Tidsramme: 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.
|
Through 6-month follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Shannon Schrader, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
30. september 2031
Studiet fullført (Antatt)
30. september 2031
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
8. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RRD9-008-25W
- RD001916-01A1 (Registeridentifikator: Department of Veteran Affairs)
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