Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
253 participants
INTERVENTIONAL
2017-06-17
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Iwin: Individual Well-Being Navigator
Iwin intervention during 6-month intervention period plus study assessments at baseline, 6, and 9 months.
Iwin: Individual Well-Being Navigator
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).
Control group
Study assessments at baseline, 6 months, and 9 months, plus two short surveys unrelated to the study behaviors at 4 and 5 months.
No interventions assigned to this group
Interventions
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Iwin: Individual Well-Being Navigator
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).
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
54 Years
ALL
Yes
Sponsors
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IMS Health
OTHER
Pro-Change Behavior Systems
OTHER
Responsible Party
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Kerry E. Evers
Co-President & CEO
Principal Investigators
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Kerry E. Evers, PhD
Role: PRINCIPAL_INVESTIGATOR
Pro-Change Behavior Systems, Inc.
Locations
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RallyPoint.com
Watertown, Massachusetts, United States
Military Media Inc.
Poughkeepsie, New York, United States
Pro-Change Behavior Systems, Inc.
South Kingstown, Rhode Island, United States
Pilot Media
Norfolk, Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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