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Observational StudyMobile Technologies Extending Reach of Primary Care for Substance Use Disorders

Sponsor:

Chess Mobile Health

Code:

NCT06208839

Conditions

Substance-Related Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SBIRT/eIntervention for those with moderate risk drug or alcohol use

SBIRT/eIntervention those assessed with high risk.

SBIRT/TAU for those with moderate risk drug or alcohol use

SBIRT/TAU for those assessed with high risk.

Study Details

Brief summary:

The goal of this clinical trial is to evaluate efficacy of our enhanced version of the CHESS Health eIntervention in a clinical setting for those with moderate risk drug or alcohol use and those at high risk or with Substance Use Disorder (SUD) as measured by the ASSIST and the AUDIT assessment tools. The clinical trial is designed to determine whether SBIRT/eIntervention is significantly more effective than SBIRT/Treatment as usual (TAU) as delivered in a primary care setting. While it is not feasible or practical to individually test all components and features of the planned eIntervention, this design will permit testing of efficacy for reduction of substance use in both risk groups and increased enrollment in treatment for the high risk/SUD group in the SBIRT/eIntervention cohorts compared to the SBIRT/TAU cohorts. Note that the investigators are not including a screening/assessment only or other control condition, as the purpose of this clinical trial is not to test the efficacy of SBIRT itself, but rather to test whether SBIRT/eIntervention improves outcomes and successful referral relative to SBIRT/TAU delivery alone.

Conditions

Substance-Related Disorders

Study ID

NCT06208839

Start date

Mar 25, 2024

Status verified date

Aug, 2024

Completion date

Apr, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

adults aged 18 or over
receiving primary care at Western Michigan
identified as having a substance-specific NIDA Modified Assist score of 27 or greater.

Exclusion Criteria:

non-English speaking
cannot read at a 3rd grade level,
have current participation in addiction treatment
determined to be psychiatrically or medically unstable such that completion of the trial is unlikely.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: SBIRT/TAU for those with moderate risk drug or alcohol use

This moderate risk group will receive the standard Screening and Brief Intervention Treatment (SBIRT) along with Treatment as Usual (TAU) at the clinic.

experimental: SBIRT/eIntervention for those with moderate risk drug or alcohol use

Subjects assigned to this condition will be instructed by the research assistant in how to download and use the eIntervention app, which they will be free to use as they like for the duration of the study. The app will contain a personalized suite of programs and activities. Unlike the TAU condition, the patient's referral to treatment would be managed through eIntervention. For example, the app will show the patient their referral details (if a referral to treatment was made), including details on the provider, referred services, and contact information, and will offer them videos of peers and professionals educating them on addiction, treatment, and sharing personal stories of recovery.

active comparator: SBIRT/TAU for those assessed with high risk.

This high risk group will receive the standard Screening and Brief Intervention Treatment (SBIRT) along with Treatment as Usual (TAU) at the clinic.

experimental: SBIRT/eIntervention those assessed with high risk.

Interventions

SBIRT/eIntervention for those with moderate risk drug or alcohol use

The Connections App is available on iOS or Android and will be offered to the patient during the referral process and contains the following functionalities:

Online view of the referrals made for them e.g. to healthcare provider
Secure messaging with the referring provider
Secure messaging with the destination provider(s) to support them to adhere to the referral, and/or the patient can seek assistance with the destination provider,
Informative multimedia content filtered from a library to fit the patient including testimonial content from peers thus showing the patient that others like them have shared their addiction experience and successfully received treatment and achieved recovery,
Capture structured feedback from the patient

The patient may access more functionality within the Connections App for those who wish to modify behavior using eTherapy and eRecovery. eRecovery includes ecological momentary assessments (EMA) selected by the provider.

SBIRT/eIntervention those assessed with high risk.

The Connections App is available on iOS or Android and will be offered to the patient during the referral process and contains the following functionalities:

Online view of the referrals made for them e.g. to healthcare provider
Secure messaging with the referring provider
Secure messaging with the destination provider(s) to support them to adhere to the referral, and/or the patient can seek assistance with the destination provider,
Informative multimedia content filtered from a library to fit the patient including testimonial content from peers thus showing the patient that others like them have shared their addiction experience and successfully received treatment and achieved recovery,
Capture structured feedback from the patient

SBIRT/TAU for those with moderate risk drug or alcohol use

Treatment as usual

SBIRT/TAU for those assessed with high risk.

Treatment as usual for high risk group

Primary outcome measure

NIDA Quick Screen [ Time Frame: Screening ]
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [ Time Frame: Screening, 3-month, and 6-month ]
The Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Screening, 3-month, and 6-month ]
Demographics [ Time Frame: Baseline ]
Demographics [ Time Frame: Baseline ]
Demographics [ Time Frame: Baseline ]
Demographics [ Time Frame: Baseline ]
TimeLine Follow-back method [ Time Frame: Baseline, 3-month, and 6-month ]
Healthcare utilization [ Time Frame: Baseline, 3-month, and 6-month ]
Contemplation ladder [ Time Frame: Baseline, 3-month, and 6-month ]
Satisfaction survey [ Time Frame: 3-month, 6 month ]

Central Contacts and Locations

Central contacts

Andrew Quanbeck, PhD

6086097308 andrew.quanbeck@gmail.com

Hans Morefield

hmorefield@chess.health

Locations

WMed Health Family Medicine

Recruiting

Kalamazoo, Michigan, United States, 49008

More Information

Sponsor

Chess Mobile Health

Last update posted

Aug 29, 2024

Last verified

Aug, 2024

Keywords

Substance Use Disorder
Screening, Brief Intervention, Referral, and Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Chess Mobile Health on 2024-08-29.