Iwin: Individual Well-Being Navigator

NCT02823535 | Completed DMC

• 1 other identifier: 271201500061C-0-0-1
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 4

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.

Conditions

Other Drug Substance Abuse

Keywords

military; veteran; military spouse

Outcome Measures

Primary Outcomes (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.

  Baseline, 6 and 9 months

Secondary Outcomes (12)

• The Assist

  Baseline, 6 and 9 months

• Progress to the Action stage for smoking cessation

  Baseline, 6 and 9 months

• Change in Well-Being

  Baseline, 6 and 9 months

• Progress to the Action stage for drinking within recommended limits

  Baseline, 6 and 9 months

• Progress to the Action stage for meeting national guidelines for physical activity

  Baseline, 6 and 9 months

Other Outcomes (5)

• Personal Financial Wellness Scale™ (PFW Scale™)

  Baseline, 6 and 9 months

• Mindful Attention Awareness Scale (MAAS), trait version

  Baseline, 6 and 9 months

• AUDIT-C

  Baseline, 6 and 9 months

Study Arms (2)

Iwin: Individual Well-Being Navigator

EXPERIMENTAL

Iwin intervention during 6-month intervention period plus study assessments at baseline, 6, and 9 months.

Behavioral: Iwin: Individual Well-Being Navigator

Control group

NO INTERVENTION

Study assessments at baseline, 6 months, and 9 months, plus two short surveys unrelated to the study behaviors at 4 and 5 months.

Interventions

Iwin: Individual Well-Being Navigator BEHAVIORAL

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).

Iwin: Individual Well-Being Navigator

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pro-Change Behavior Systems: lead
• IMS Health: collaborator

Study Sites (4)

RallyPoint.com

Watertown, Massachusetts, 02472, United States

Location

Military Media Inc.

Poughkeepsie, New York, 12601, United States

Location

Pro-Change Behavior Systems, Inc.

South Kingstown, Rhode Island, 02879, United States

Location

Pilot Media

Norfolk, Virginia, 23510, United States

Location

Related Publications (9)

• 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.

  PMID: 12199834 BACKGROUND

• 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.

  PMID: 18373724 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 16846327 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 18696313 BACKGROUND

• 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.

  PMID: 8223364 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Kerry E. Evers, PhD

  Pro-Change Behavior Systems, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-President & CEO

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 6, 2016
• Study Start: June 17, 2017
• Primary Completion: July 12, 2018
• Study Completion: December 31, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)