mHealth App for Changing Alcohol Use in Alaska Native American Indian People

NCT05326438 | Unknown

• 1 other identifier: 2021-12-056
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

For many people who have trouble with alcohol, peer support - the opportunity to share challenges, problem-solving strategies, and successes with supportive others - can be helpful. Building on Southcentral Foundation's (SCF's) established learning circles for sobriety support, the goal of this study is to culturally adapt and test the acceptability and feasibility of a smartphone app for sobriety support among Alaska Native and American Indian (AN/AI) people. In Aims 1 and 2 of this study, the investigators used input from patients and providers to culturally adapt a commercially available mHealth app for AN/AI people dealing with alcohol misuse. The investigators then merged culturally relevant content (e.g., stories and music) and skill-building modules based on the Community Reinforcement Approach with the existing informational and peer support features of the Connections app, a product of CHESS Health accessible on smartphones and tablets. The investigators will work with up to 125 SCF patients to assess the acceptability, feasibility, and measurable effects of the culturally-adapted app among AN/AI adults 21 and older, relying on questionnaires and interviews to evaluate the app features and utility. The study's primary outcome is the feasibility and acceptability of the modified CHESS app for AN/AI people as a tool for sobriety. The secondary outcomes are to examine changes in quality of life, alcohol use and problems, self-efficacy in sobriety, and stages of change over the course of using the app. The investigators will also explore whether alcohol use and problems are mediated by frequency of app use, app satisfaction, and alcohol self-efficacy.

Conditions

Alcohol Use Disorder

Keywords

Alaska Native; mHealth app; behavioral interventions; alcohol use disorder

Outcome Measures

Primary Outcomes (7)

• Feasibility and acceptability of the app

  Through qualitative interviews, determine the feasibility and acceptability of the Connections app with Alaska Native and American Indian people to modify drinking behavior. 25 participants will be interviewed after they have trialed the app over a 6 month time period.

  6 months post app use

• Changes in alcohol and drug use over time

  Examine changes in alcohol and drug use with the Alcohol Use Disorders Identification Test - 3 (3 items). The scale is scored from 0-12 (where scores of 0 reflect no alcohol use). The higher the score, the more likely it is that the person's drinking is affecting his/her health and safety; higher scores thus reflect greater use of alcohol and is a worse outcome. All participants will be queried.

  Baseline, 3 months after using app, 6 months after using app

• Changes in self-efficacy to avoid drinking

  Examine changes in self-efficacy to modify behavior over time of app use using a single item: "How confident are you that you will be able to manage your drinking in the next 90 days, or 3 months?" Scores range from 1 (no confidence) to 10 (very confident). Higher scores indicate greater confidence and better outcome. All participants will be queried.

  Baseline, 3 months after using app, 6 months after using app

• Changes in alcohol associated problems

  Examine whether problems associated with drinking changes over time using the Short Inventory of Problems - Revised. This questionnaire has 6 items and responses are answered from "0" (never) to "3" (always), with answers ranging from 0 to 18. Lower scores mean fewer problems; higher scores mean greater problems and suggest a worse outcome. All participants will be queried.

  Baseline, 3 months after using app, 6 months after using app

• Changes in motivation to change alcohol use

  Examine whether readiness for treatment changes over time using the Stages of Change Readiness and Treatment Eagerness Scale (19 items). Lower scores indicate poorer readiness, higher scores indicate better outcome and higher motivation. Scores range from 19 to 95. All participants will be queried.

  Baseline, 3 months after using app, 6 months after using app

• Changes in quality of life scores

  Examine World Health Organization Quality-of-Life Scale to evaluate physical, psychological, social, environmental changes in quality of life, as well as overall quality of life and health. The 26-item instrument covers four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains quality of life and general health items. Each individual item of the scale is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher scores indicate better outcome, or better quality of life. All participants will be queried.

  Baseline, 3 months after using app, 6 months after using app

• Changes in positive and negative affect scores

  Examine positive and negative affect using the short form of the positive and negative affect schedule. There are two subscales, five items for positive affect and five items for negative affect. The scale is answered from "1" for very slightly or not at all to "5" for extreme. Scores on each scale can range from 5 to 25. Lower scores indicate less of this type of affect. Higher positive affect scores is a better outcome for the study; higher negative affect scores is a poorer outcome for the study. All participants will be queried.

  Baseline, 3 months after using app, 6 months after using app

Study Arms (1)

CIRCLE mHealth app

EXPERIMENTAL

The investigators will trial a modified version of the mHealth app called "Connections" with Alaska Native/American Indian people who want to change the way they use alcohol.

Behavioral: CIRCLE mHealth app

Interventions

CIRCLE mHealth app BEHAVIORAL

For the intervention, participants will be given access to an mHealth sobriety app that has been modified for Alaska Native/American Indian people. The app allows people to track their sobriety, learn new recovery skills, track treatment plans, set reminders, journal about their recovery, and discover helpful videos and testimonials through an extensive resource library that includes culturally meaningful content, graphics, music, videos, recovery tools, and testimonials. Users can also participate in an interactive peer platform and/or participate in group chats to engage participants in facilitated discussions about sobriety, lifestyle changes, cultural content, and Community Reinforcement Approach skill-building.

Also known as: Connections, created by CHESS Health

CIRCLE mHealth app

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alaska Native/American Indian;
• ≥ 21 years of age;
• Having a desire to change drinking behavior;
• Receiving services at Southcentral Foundation and reside in the Anchorage Service Unit (urban and rural);
• English-speaking;
• Having access to a smartphone or tablet.

You may not qualify if:

• Not Alaska Native/American Indian;
• Non-English speaking;
• Having a medical or severe psychiatric condition that the PIs determine would make it difficult for the individual to use the app or participate in the interview;
• Not having access to a smartphone or tablet (e.g., iPad, Kindle Fire, etc.).

Sponsors & Collaborators

• Southcentral Foundation: lead
• University of Washington: collaborator

Study Sites (1)

Southcentral Foundation

Anchorage, Alaska, 99508, United States

Location

Related Publications (5)

• Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.

  PMID: 9738608 RESULT

• Hoeppner BB, Kelly JF, Urbanoski KA, Slaymaker V. Comparative utility of a single-item versus multiple-item measure of self-efficacy in predicting relapse among young adults. J Subst Abuse Treat. 2011 Oct;41(3):305-12. doi: 10.1016/j.jsat.2011.04.005. Epub 2011 Jun 22.

  PMID: 21700411 RESULT

• Kiluk BD, Dreifuss JA, Weiss RD, Morgenstern J, Carroll KM. The Short Inventory of Problems - revised (SIP-R): psychometric properties within a large, diverse sample of substance use disorder treatment seekers. Psychol Addict Behav. 2013 Mar;27(1):307-14. doi: 10.1037/a0028445. Epub 2012 May 28.

  PMID: 22642856 RESULT

• Maisto SA, Conigliaro J, McNeil M, Kraemer K, O'Connor M, Kelley ME. Factor structure of the SOCRATES in a sample of primary care patients. Addict Behav. 1999 Nov-Dec;24(6):879-92. doi: 10.1016/s0306-4603(99)00047-7.

  PMID: 10628520 RESULT

• Thompson, E. R. (2007). Development and validation of an internationally reliable short-form of the positive and negative affect schedule (PANAS). Journal of cross-cultural psychology, 38(2), 227-242.

  RESULT

Related Links

• WHO Quality of Life Scale, BREF version

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ann D Collier, Ph.D.

  Southcentral Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 13, 2022
• Study Start: August 10, 2022
• Primary Completion: June 15, 2024
• Study Completion: July 30, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)