Development of a Mobile Health Intervention to Support Functioning of Veterans With Substance Use Disorders
2026년 6월 8일 업데이트: 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.
연구 개요
상세 설명
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).
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Shannon Schrader, PhD
- 전화번호: (203) 892-3624
- 이메일: shannon.schrader@va.gov
연구 장소
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Connecticut
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West Haven, Connecticut, 미국, 06516-2770
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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연락하다:
- Shannon Schrader, PhD
- 전화번호: 203-892-3624
- 이메일: shannon.schrader@va.gov
-
수석 연구원:
- Shannon Schrader, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention
Intervention condition
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Motivational Enhancement Therapy Skills for Veterans mobile app based intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intervention Usability (Systems Usability Scale)
기간: 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.
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Through 3-month follow-up assessment
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Intervention Acceptability (mHealth Satisfaction Questionnaire)
기간: Through 3-month follow-up assessment
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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)
기간: Through 6-month follow-up assessment
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Psychosocial functioning (Brief Inventory of Psychosocial Functioning)
기간: Through 6-month follow-up
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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
기간: Through 6-month follow-up
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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
기간: Through 6-month follow-up
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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)
기간: Through 6-month follow-up
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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.
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Through 6-month follow-up
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Quality of Life (VAS)
기간: Through 6-month follow-up
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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.
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Through 6-month follow-up
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Substance Use (ASI)
기간: Through 6-month follow-up
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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
기간: Through 6-month follow-up
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Shannon Schrader, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2031년 9월 30일
연구 완료 (추정된)
2031년 9월 30일
연구 등록 날짜
최초 제출
2026년 6월 2일
QC 기준을 충족하는 최초 제출
2026년 6월 8일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 8일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .