Iwin: Individual Well-Being Navigator

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
The overarching objective of this project 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. Military personnel, veterans, and military spouses recruited will be asked to complete a series of screening questions on their personal mobile devices. An estimated 476 Personnel will need to be screened to arrive at an eligible sample of 238. Randomization of the eligible sample will occur within the online baseline assessment at the individual level as soon as a participant completes the Informed Consent form. Those randomized to the Control Group (n=119) will complete assessments at baseline, 6 months, and 9 months. Additionally, the control group will complete a short survey unrelated to the study behaviors at 4 and 5 months to match incentives given to the intervention group. Those randomized to the Intervention Group (n=119) will complete the same schedule of assessments as the control group and in addition will have access to the Iwin application (app) in between the baseline and 6 month assessments. The assessments include a variety of questions on health, wellness, substance use and well-being. Users randomized into the intervention group will be able to download the Iwin app for free onto their personal device. The Pro-Change Iwin application has been built using the IMS Health AppNucleus™ Platform. AppNucleus is a patented, federally certified (FIPS 140-2, DIACAP MAC II Sensitive), secure application platform that enables Pro-Change to rapidly deploy secure mHealth solutions to users via web portal and commercial mobile technologies (such as iOS, Android, Windows Phone, Blackberry). The application provides an innovative, tailored program 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 for their individual needs. It delivers assessments and tailored feedback immediately on eleven different risk behaviors as well as mobile interactive staged matched activities, engaging game-like features and in-app notifications on each behavior they are at risk for over the course of 6 months. The app will provide reminders for users to return to the program as set time points. Both intervention and control participants will receive e-mail reminders to complete follow-up assessments at 6 and 9 months. PRIVACY All information shared with us will be kept confidential to the extent provided by law. Names will not be connected to survey answers. Instead, a code will be used in place of a name in the research study records. Access to the research records will be limited to the research study team. The research records will be deleted three years after the submission of the final financial report in accordance with OMB Circular A-110. To help us protect participant privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that may identify a participant in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify a partcipant. There is one exception to the promise of confidentiality: if we see or are told that someone is planning to harm themselves or someone else, we will disclose this information to the proper authorities. The Certificate cannot be used to resist a demand for information from personnel of the United States federal or state government agency sponsoring the project and that will be used for auditing or program evaluation of agency funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). A Certificate of Confidentiality does not prevent a participant or a member of their family from voluntarily releasing information about the participant or their involvement in this research. If an insurer, medical care provider, or other person obtains a participants written consent to receive research information, then the researchers will not use the Certificate to withhold that information.

Official Title
-----------------
iWin: Navigating Your Path to Well-Being

Conditions
-----------------
Other Drug Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Iwin: Individual Well-Being Navigator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Between 18 and 54 years of age Member of the U.S. Military (active duty, active reservist), Veteran, Military Spouse (only one member of each household is eligible) Have access to a mobile device with Internet connectivity Comfortable using applications on a mobile device Have access to an email account they check at least weekly. Exclusion Criteria: Pregnant Significant head injury or other condition that could prevent using mobile device Admitted to an inpatient mental health facility in the past two years Suicidal ideation Moderately severe depression - i.e., score of > 15 on the Patient Health Questionnaire-8 (PHQ-8) Severe PTSD symptoms (PCL-5 score > 61).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iwin: Individual Well-Being Navigator<br>Iwin intervention during 6-month intervention period plus study assessments at baseline, 6, and 9 months. | Behavioral: Iwin: Individual Well-Being Navigator<br>* Immediately following the baseline assessment, the Intervention Group will receive a secure link to download the IWin app. The app provides three types of integrated interventions: 1) stage-matched feedback on the participant's risk behaviors as determined via the assessments; 2) up to two in app messages a day determined by a series of algorithms that control the timing, content, and cadence of the messages; and 3) up to two prompts a week to complete stage-matched activities that foster behavior change (e.g., quizzes, calculators, guided visualizations, info-graphics, testimonials, and more).<br>|
| No Intervention: Control group<br>Study assessments at baseline, 6 months, and 9 months, plus two short surveys unrelated to the study behaviors at 4 and 5 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
military, veteran, military spouse