Development of a Mobile Health Intervention to Support Functioning of Veterans With Substance Use Disorders
8 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Shannon Schrader, PhD
- Numero di telefono: (203) 892-3624
- Email: shannon.schrader@va.gov
Luoghi di studio
-
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Connecticut
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West Haven, Connecticut, Stati Uniti, 06516-2770
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Contatto:
- Shannon Schrader, PhD
- Numero di telefono: 203-892-3624
- Email: shannon.schrader@va.gov
-
Investigatore principale:
- Shannon Schrader, PhD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Intervention
Intervention condition
|
Motivational Enhancement Therapy Skills for Veterans mobile app based intervention
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Intervention Usability (Systems Usability Scale)
Lasso di tempo: Through 3-month follow-up assessment
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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)
Lasso di tempo: 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.
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Through 3-month follow-up assessment
|
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Study Feasibility (rates of attrition)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Psychosocial functioning (Brief Inventory of Psychosocial Functioning)
Lasso di tempo: 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.
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Through 6-month follow-up
|
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Substance use
Lasso di tempo: 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).
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Through 6-month follow-up
|
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Sleep
Lasso di tempo: 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.
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Through 6-month follow-up
|
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Quality of Life (VR-12)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Shannon Schrader, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
30 settembre 2031
Completamento dello studio (Stimato)
30 settembre 2031
Date di iscrizione allo studio
Primo inviato
2 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
8 giugno 2026
Primo Inserito (Effettivo)
12 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RRD9-008-25W
- RD001916-01A1 (Identificatore di registro: Department of Veteran Affairs)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .