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Other Drug Substance AbuseNCT02823535

Iwin: Individual Well-Being Navigator

A study testing Iwin: Individual Well-Being Navigator in people with Other Drug Substance Abuse, run by Pro-Change Behavior Systems at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Other Drug Substance Abuse
What is being tested?
Iwin: Individual Well-Being Navigator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
4 sitesUnited States
Study dates
17 Jun 2017to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Pilot Media

    Norfolk, Virginia, 23510

  • Military Media Inc.

    Poughkeepsie, New York, 12601

  • Pro-Change Behavior Systems, Inc.

    South Kingstown, Rhode Island, 02879

  • RallyPoint.com

    Watertown, Massachusetts, 02472

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Iwin: Individual Well-Being Navigator
Keywords
military, veteran, military spouse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iwin: Individual Well-Being NavigatorBehavioural

    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).

Study groups in NCT02823535
Study groupRoleWhat they receive
Iwin: Individual Well-Being NavigatorExperimentalIwin intervention during 6-month intervention period plus study assessments at baseline, 6, and 9 months.
Receives: Behavioral: Iwin: Individual Well-Being Navigator
Control groupNo interventionStudy assessments at baseline, 6 months, and 9 months, plus two short surveys unrelated to the study behaviors at 4 and 5 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 6 and 9 months

Secondary outcomes (12)

  1. 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.

    Measured: Baseline, 6 and 9 months

  2. 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)

    Measured: Baseline, 6 and 9 months

  3. 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.

    Measured: Baseline, 6 and 9 months

  4. 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)

    Measured: Baseline, 6 and 9 months

  5. 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)

    Measured: Baseline, 6 and 9 months

  6. 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)

    Measured: Baseline, 6 and 9 months

  7. 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)

    Measured: Baseline, 6 and 9 months

  8. 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)

    Measured: Baseline, 6 and 9 months

  9. 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)

    Measured: Baseline, 6 and 9 months

  10. 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)

    Measured: Baseline, 6 and 9 months

  11. 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.

    Measured: Baseline, 6 and 9 months

  12. Brief Resilience Scale (BRS)

    The BRS is a reliable means of assessing resilience as the ability to bounce back or recover from stress.

    Measured: Baseline, 6 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study start17 Jun 2017
  3. Primary completion12 Jul 2018
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823535
Sponsor's protocol ID
271201500061C-0-0-1
Status last verified
Mar 2020
First submitted
30 Jun 2016
Last updated
4 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.

    PubMed 12199834

  • Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikarn J, de Lacerda RB, Ling W, Marsden J, Monteiro M, Nhiwatiwa S, Pal H, Poznyak V, Simon S. Validation of the Alcohol, Smoking And Substance Involvement Screening Test (ASSIST). Addiction. 2008 Jun;103(6):1039-47. doi: 10.1111/j.1360-0443.2007.02114.x. Epub 2008 Mar 28.

    PubMed 18373724

  • Humeniuk, R., Dennington, v., ali R., The Effectiveness of a brief Intervention for Illicit Drugs Linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in Primary Health Care Settings: A Technical Report of Phase III Findings of the WHO ASSIST Randomized Controlled Trial. Geneva: World Health Organization. 2008. Available at http://www.who.int/substance_abuse/activities/assist_techhnicalreport_phase3_final.pdf (access 24 February 2015).

  • Evers KE, Prochaska JO, Johnson JL, Mauriello LM, Padula JA, Prochaska JM. A randomized clinical trial of a population- and transtheoretical model-based stress-management intervention. Health Psychol. 2006 Jul;25(4):521-9. doi: 10.1037/0278-6133.25.4.521.

    PubMed 16846327

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PubMed 18696313

  • Prochaska JO, DiClemente CC, Velicer WF, Rossi JS. Standardized, individualized, interactive, and personalized self-help programs for smoking cessation. Health Psychol. 1993 Sep;12(5):399-405. doi: 10.1037//0278-6133.12.5.399.

    PubMed 8223364

  • Prochaska J, Prochaska J, Prochaska J. Building a science for multiple-risk behavior change. In: Riekert KA, Ockene JK, Pbert L, editors. The handbook of health behavior change. 4 ed. New York: Springer; 2014. p. 245-67.

  • Prochaska JO, Redding C, Evers K. The Transtheoretical model and stages of change. In: Glanz K, Rimer BK, Viswanath K, editors. Health Behavior and Health Education: Theory, Research and Practice. 4 ed. San Francisco, CA: Jossey-Bass; 2008. p. 97-122.

Questions about this trial

What is this clinical trial studying?

A study testing Iwin: Individual Well-Being Navigator in people with Other Drug Substance Abuse, run by Pro-Change Behavior Systems at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Risk Behaviors Index (time frame: Baseline, 6 and 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823535, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020; AzTrials last refreshed its copy on 29 Oct 2026.

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