VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770, United States
Location contact
Shannon Schrader, PhD
CONTACT
Shannon Schrader, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07645131
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
West Haven, Connecticut, 06516-2770, United States
Shannon Schrader, PhD
CONTACT
Shannon Schrader, PhD
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Motivational Enhancement Therapy Skills for Veterans mobile app based intervention
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
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