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

Primary Purpose

Alcohol Use Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CIRCLE mHealth app
Sponsored by
Southcentral Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alaska Native, mHealth app, behavioral interventions, alcohol use disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (self-reported as):

  • 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.

Exclusion Criteria (self-reported as):

  • 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.).

Sites / Locations

  • Southcentral Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CIRCLE mHealth app

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2022
Last Updated
May 22, 2023
Sponsor
Southcentral Foundation
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05326438
Brief Title
mHealth App for Changing Alcohol Use in Alaska Native American Indian People
Acronym
CIRCLE
Official Title
Cultural Innovations for Recovery in Community-Based Learning Environments (CIRCLE) Phase 3: Testing an Online Learning Community Application
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southcentral Foundation
Collaborators
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Southcentral Foundation (SCF) has a long history of stakeholder engagement, recognizing that engaged patients seek out information, work collaboratively with providers, and are more likely to demonstrate healthy choices and disease-specific self-management behaviors. SCF has used qualitative methods to identify and meet the changing needs of patients. Building on work in Aim 1 and Aim 2, which provided patient feedback about both the Connections app and the intended measurement tools, work in this Aim will include testing a modified version of the app with SCF patients. The Connections app supports individuals in recovery by reducing relapse and promoting prosocial engagement. 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. The app also has a "recovery help button" that can be pressed whenever the participant needs urgent help. Examples of Connections content include motivational talks, meditations, addiction recovery speakers, stress management, and anger management. The study team added additional culturally meaningful content, graphics, music, videos, recovery tools, and testimonials. Connections uses a HIPAA and HITRUST compliant interactive peer platform, which allows users to privately message one another and/or participate in group chats. The investigators will utilize the app's mass messaging and group chat capabilities to engage participants in facilitated discussions that are consistent with the policies, services, and treatment philosophies of SCF. The study team will add additional topics such as sobriety, lifestyle changes, cultural content, and skill-building modules based on the Community Reinforcement Approach. Participants will be asked to utilize the app for at least 3 months, with a 6-month follow-up. Participation in the study will be entirely voluntary and confidential. The investigators plan to recruit no more than 125 AN/AI adults who report a desire to change their alcohol use patterns. The investigators will attempt to recruit at SCF in such a way as to have adequate representation from urban and rural residing customer-owners. Individuals may or may not be engaged in or have a history of treatment services specifically for alcohol use disorders. The investigators will not access customer-owners' medical records for recruitment purposes. The investigators also plan to interview up to 25 participants at the 6-month mark, gathering qualitative data about their experiences using the app. Data Analytic Plan: Interviews will be transcribed verbatim and de-identified prior to analysis. Transcripts will be validated for accuracy and uploaded to ATLAS.ti for data management and coding, with categorical demographic information. Members of the qualitative research team will conduct analysis in four iterative steps: (1) familiarizing themselves with the data, (2) generating or applying a priori and emergent codes to the data, (3) searching for thematic patterns, and (4) searching for demographic patterns. Consistency will be maintained through a shared codebook, team coding of selected transcripts, and regular meetings to discuss and resolve discrepancies. Data analysis of feasibility and acceptability of the Connections app will include descriptive statistics of counts of interaction with the app and total number of days the app was accessed. Bivariate descriptive statistics will be used to examine differences in feasibility by demographics and baseline observations. Data analysis for survey data will include descriptive statistics and mixed effects modeling to account for correlation of repeated measures within customer-owner participants for quality of life, alcohol use and problems, self-efficacy in sobriety, and stages of change completed in partnership with our external consultants. As part of this analysis, data will be evaluated for selection bias, and measurement error or misclassification bias that are common challenges in repeated measures and longitudinal public health datasets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Alaska Native, mHealth app, behavioral interventions, alcohol use disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CIRCLE mHealth app
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CIRCLE mHealth app
Other Intervention Name(s)
Connections, created by CHESS Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and acceptability of the app
Description
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.
Time Frame
6 months post app use
Title
Changes in alcohol and drug use over time
Description
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.
Time Frame
Baseline, 3 months after using app, 6 months after using app
Title
Changes in self-efficacy to avoid drinking
Description
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.
Time Frame
Baseline, 3 months after using app, 6 months after using app
Title
Changes in alcohol associated problems
Description
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.
Time Frame
Baseline, 3 months after using app, 6 months after using app
Title
Changes in motivation to change alcohol use
Description
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.
Time Frame
Baseline, 3 months after using app, 6 months after using app
Title
Changes in quality of life scores
Description
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.
Time Frame
Baseline, 3 months after using app, 6 months after using app
Title
Changes in positive and negative affect scores
Description
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.
Time Frame
Baseline, 3 months after using app, 6 months after using app

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (self-reported as): 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. Exclusion Criteria (self-reported as): 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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann D Collier, Ph.D.
Organizational Affiliation
Southcentral Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southcentral Foundation
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9738608
Citation
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.
Results Reference
result
PubMed Identifier
21700411
Citation
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.
Results Reference
result
PubMed Identifier
22642856
Citation
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.
Results Reference
result
PubMed Identifier
10628520
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Links:
URL
https://www.who.int/tools/whoqol/whoqol-bref
Description
WHO Quality of Life Scale, BREF version

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

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