Development of a Mobile Health Intervention to Support Functioning of Veterans With Substance Use Disorders

ConditionSubstance Use
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

current Substance Use Disorder (SUD) diagnosis according to chart review

current enrollment in VACHS residential Substance Use Disorder (SUD) treatment program

competent to provide written informed consent

a working smartphone with wireless capabilities or willingness to use a study-provided smartphone

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • METS4Vets

    Behavioral

    Motivational Enhancement Therapy Skills for Veterans mobile app based intervention

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intervention Usability (Systems Usability Scale)

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
2

Intervention Acceptability (mHealth Satisfaction Questionnaire)

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 3-month follow-up assessment
3

Study Feasibility (rates of attrition)

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 assessment

Secondary outcomes

1

Psychosocial functioning (Brief Inventory of Psychosocial Functioning)

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
2

Substance use

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
3

Sleep

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
4

Quality of Life (VR-12)

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

Other outcomes

Sponsors and contacts

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