Web-based Addiction Treatment: Cultural Adaptation With American Indians

NCT ID: NCT03363256

Last Updated: 2021-11-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2020-09-30

Brief Summary

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The purpose of the current study is to evaluate the preliminary efficacy of the Therapeutic Education System-Native Version (TES-NAV) (an efficacious web-delivered psychosocial intervention for substance use disorders adapted with American Indians/Alaska Natives \[AI/AN\]) to determine whether a future large-scale effectiveness trial is warranted. Specifically, a randomized controlled trial among urban AI/AN (N=80) attending outpatient addiction treatment services will be conducted to (1) estimate preliminary effect size of 12 weeks of TES-NAV on substance use disorder outcomes; (2) explore relevant moderators of TES-NAV outcomes; and (3) assess cultural factors that may correspond to variation in outcome.

Detailed Description

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Conditions

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Substance Use Disorders

Keywords

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Digital therapeutics Adaptation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAU+TES-NAV

Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN

Group Type EXPERIMENTAL

TES-NAV

Intervention Type BEHAVIORAL

Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN

TAU

Intervention Type BEHAVIORAL

Standard outpatient addiction treatment

TAU

Standard outpatient addiction treatment

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type BEHAVIORAL

Standard outpatient addiction treatment

Interventions

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TES-NAV

Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN

Intervention Type BEHAVIORAL

TAU

Standard outpatient addiction treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Identify as American Indian or Alaska Native
* Recent alcohol or drug use
* Within first 30 days of current outpatient treatment episode

Exclusion Criteria

* Planned treatment episode of less than 3 months
* Insufficient ability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Aimee Campbell

Associate Professor of Clinical Psychiatric Social Work

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Native American Rehabilitation Association of the Northwest, Inc.

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Campbell AN, Turrigiano E, Moore M, Miele GM, Rieckmann T, Hu MC, Kropp F, Ringor-Carty R, Nunes EV. Acceptability of a web-based community reinforcement approach for substance use disorders with treatment-seeking American Indians/Alaska Natives. Community Ment Health J. 2015 May;51(4):393-403. doi: 10.1007/s10597-014-9764-1. Epub 2014 Jul 15.

Reference Type BACKGROUND
PMID: 25022913 (View on PubMed)

Campbell AN, Nunes EV, Matthews AG, Stitzer M, Miele GM, Polsky D, Turrigiano E, Walters S, McClure EA, Kyle TL, Wahle A, Van Veldhuisen P, Goldman B, Babcock D, Stabile PQ, Winhusen T, Ghitza UE. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014 Jun;171(6):683-90. doi: 10.1176/appi.ajp.2014.13081055.

Reference Type BACKGROUND
PMID: 24700332 (View on PubMed)

Campbell ANC, Rieckmann T, Pavlicova M, Choo TH, Molina K, McDonell M, West AE, Daw R, Marsch LA, Venner KL. Culturally tailored digital therapeutic for substance use disorders with urban Indigenous people in the United States: A randomized controlled study. J Subst Use Addict Treat. 2023 Dec;155:209159. doi: 10.1016/j.josat.2023.209159. Epub 2023 Sep 9.

Reference Type DERIVED
PMID: 37690525 (View on PubMed)

Other Identifiers

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R34DA040831

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#7555

Identifier Type: -

Identifier Source: org_study_id