Other Drug Substance Abuse Clinical Trial
Official title:
iWin: Navigating Your Path to Well-Being
| Verified date | March 2020 |
| Source | Pro-Change Behavior Systems |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The overarching objective of this proposal is to conduct a randomized trial to evaluate the effectiveness of the Individual Well-Being Navigator (Iwin) mobile application, a substance abuse prevention and well-being enhancement program designed specifically for military personnel, veterans, and military spouses. Iwin provides an innovative, tailored mobile application using best practices in behavior change science and innovative technology to assist users in preventing substance abuse and enhancing well-being by providing them with the most appropriate intervention content at the right time. It integrates Transtheoretical Model of Behavior Change based tailoring, in app messaging, stage of change matched activities, and engaging game-like features in a cutting edge multiple behavior change program. The efficacy of the Iwin program will be determined by tests of statistical significance indicating that participants in the Treatment condition had lower scores on an index of substance use and other behavioral risks. The overall design is a 2 group (treatment and control group) by 3 Occasions with repeated measures across occasions.
| Status | Completed |
| Enrollment | 253 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | July 12, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 54 Years |
| Eligibility |
Inclusion Criteria: 1. English speaking 2. Between 18 and 54 years of age 3. Member of the U.S. Military (active duty, active reservist), Veteran, Military Spouse (only one member of each household is eligible) 4. Have access to a mobile device with Internet connectivity 5. Comfortable using applications on a mobile device 6. Have access to an email account they check at least weekly. Exclusion Criteria: 1. Pregnant 2. Significant head injury or other condition that could prevent using mobile device 3. Admitted to an inpatient mental health facility in the past two years 4. Suicidal ideation 5. Moderately severe depression - i.e., score of > 15 on the Patient Health Questionnaire-8 (PHQ-8) 6. Severe PTSD symptoms (PCL-5 score > 61). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pilot Media | Norfolk | Virginia |
| United States | Military Media Inc. | Poughkeepsie | New York |
| United States | Pro-Change Behavior Systems, Inc. | South Kingstown | Rhode Island |
| United States | RallyPoint.com | Watertown | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Pro-Change Behavior Systems | IMS Health |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Personal Financial Wellness Scale™ (PFW Scale™) | The Personal Financial Wellness Scale™ (PFW Scale™) is an eight-question, self-report measure of perceived financial distress and financial well-being. The instrument measures how people are doing along a continuum extending from negative to positive feelings about and reactions to their financial situations. The tool has been scientifically determined to be a valid and reliable measure of personal financial wellness. | Baseline, 6 and 9 months | |
| Other | Mindful Attention Awareness Scale (MAAS), trait version | The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. | Baseline, 6 and 9 months | |
| Other | AUDIT-C | Alcohol Use Disorders Identification Test-Consumption (AUDIT-C): a three-item scale used to assess drinking severity and as an indicator of dependence. | Baseline, 6 and 9 months | |
| Other | Personal Wellbeing Index (PWI) | The PWI scale contains seven items of satisfaction, each one corresponding to a quality of life domain as: standard of living, health, achieving in life, relationships, safety, community-connectedness, and future security. | Baseline, 6 and 9 months | |
| Other | Current Tobacco Use Status | Assessment of current tobacco use (all forms) | Baseline, 6 and 9 months | |
| Primary | Health Risk Behaviors Index | Assesses risk status and stage of change for eleven health risk behaviors including: smoking, alcohol (risky drinking), financial well-being, other substance use, stress management, pain management, depression management, sleep management, regular exercise). Previous research has used this measure as an indicator of the effectiveness of an intervention for overall multiple behavior change. | Baseline, 6 and 9 months | |
| Secondary | The Assist | The ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test) is an 8 item questionnaire that takes about 5-10 minutes to complete. Originally developed by the World Health Organization primarily for use in primary care settings to identify patients who substance use may be classified as moderate level, it has been adapted in a range of studies for use in other populations and research . This tool has also been adapted by NIDA and published online as a tool for clinicians. It screens for problem or risky use of tobacco, alcohol, cannabis, cocaine, ATS, sedatives, hallucinogens, inhalants, opioids, and other drugs. A risk score is developed for each category, as well as an overall risk score . Previous studies have used changes in this score as at test of effectiveness of interventions successfully. | Baseline, 6 and 9 months | |
| Secondary | Progress to the Action stage for smoking cessation | Will only be assessed among patients smoking at baseline (exploratory analysis; study is not powered to find significance) | Baseline, 6 and 9 months | |
| Secondary | Change in Well-Being | Change in well-being will be computed by taking the difference in the Cantril Self-Anchoring Scale (Cantril, 1965) from baseline to 12 months follow-up. The measure asks participants to imagine a ladder with steps numbered from zero to ten, with the top representing the best possible life and the bottom representing the worst possible life, and to indicate where they feel their life falls currently and where it will be in five years. | Baseline, 6 and 9 months | |
| Secondary | Progress to the Action stage for drinking within recommended limits | Will only be assessed among patients exceeding recommended limits at baseline (exploratory analysis; study is not powered to find significance) | Baseline, 6 and 9 months | |
| Secondary | Progress to the Action stage for meeting national guidelines for physical activity | Will only be assessed among patients not meeting national guidelines for physical activity at baseline (exploratory analysis; study is not powered to find significance) | Baseline, 6 and 9 months | |
| Secondary | Progress to the Action stage for managing depression | Will only be assessed among patients with at least mild depression (PHQ-8 score of 5 or higher) at baseline (exploratory analysis; study is not powered to find significance) | Baseline, 6 and 9 months | |
| Secondary | Progress to the Action stage for drug use | Will only be assessed among those indicating drug use at baseline (exploratory analysis; study is not powered to find significance) | Baseline, 6 and 9 months | |
| Secondary | Progress to the Action stage sleep management | Will only be assessed among patients not meeting recommended hours at baseline (exploratory analysis; study is not powered to find significance) | Baseline, 6 and 9 months | |
| Secondary | Progress to the Action stage stress management | Will only be assessed among patients not managing their stress effectively at baseline (exploratory analysis; study is not powered to find significance) | Baseline, 6 and 9 months | |
| Secondary | Change in level of depression | Will be assessed using the Patient Health Questionnaire (PHQ-8) (Kroenke, Strine, Spritzer, Williams, Berry, & Mokdad, 2009) only among patients with at least mild depression (PHQ-8 score of 5 or higher) at baseline (exploratory analysis; study is not powered to find significance) | Baseline, 6 and 9 months | |
| Secondary | WHO-5 Well-being Index | The 5-item World Health Organization Well-Being Index (WHO-5) is among the most widely used questionnaires assessing subjective psychological well-being. | Baseline, 6 and 9 months | |
| Secondary | Brief Resilience Scale (BRS) | The BRS is a reliable means of assessing resilience as the ability to bounce back or recover from stress. | Baseline, 6 and 9 months |