Development of a Mobile Health Intervention to Support Functioning of Veterans With Substance Use Disorders
8 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Shannon Schrader, PhD
- Numéro de téléphone: (203) 892-3624
- E-mail: shannon.schrader@va.gov
Lieux d'étude
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Connecticut
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West Haven, Connecticut, États-Unis, 06516-2770
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Contact:
- Shannon Schrader, PhD
- Numéro de téléphone: 203-892-3624
- E-mail: shannon.schrader@va.gov
-
Chercheur principal:
- Shannon Schrader, PhD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
Intervention condition
|
Motivational Enhancement Therapy Skills for Veterans mobile app based intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention Usability (Systems Usability Scale)
Délai: 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)
Délai: 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
|
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Study Feasibility (rates of attrition)
Délai: 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.
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Through 6-month follow-up assessment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Psychosocial functioning (Brief Inventory of Psychosocial Functioning)
Délai: 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
|
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Substance use
Délai: 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
Délai: 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
|
|
Quality of Life (VR-12)
Délai: 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)
Délai: 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
|
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Substance Use (ASI)
Délai: 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.
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Through 6-month follow-up
|
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Treatment engagement
Délai: 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.
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Through 6-month follow-up
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Shannon Schrader, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
30 septembre 2031
Achèvement de l'étude (Estimé)
30 septembre 2031
Dates d'inscription aux études
Première soumission
2 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RRD9-008-25W
- RD001916-01A1 (Identificateur de registre: Department of Veteran Affairs)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .