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NCT Number: NCT06346431

Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms

The focus of this study is the impact of usage of a mobile application to support problem-solving therapy on symptoms of anxiety, depression and substance use.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Depressive Symptoms Mental Disorders Substance Use Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

Tribal communities have a problem. They experience a disproportionate rate of substance use and mental illness. Research shows that customized digital tools designed with the community, integrating local culture and resources are more effective in reducing symptoms of anxiety and depression. However, the cost of design and development renders quality app creation for small markets infeasible. Digital Support for Problem-Solving Therapy in a Tribal Community (DSPT) solves this problem through dramatically reducing software design time by using AI for task analysis and to combine tasks, service programs' geographic coordinates and hours and applying the proprietary 7 Gen Blocks software components to reduce development time. The resulting mobile application will be used by intervention groups on two reservations. At baseline, three months and six months post, both the intervention and randomly assigned control group (total N =100) will complete standardized, validated measures of depression, anxiety and substance use disorder symptoms. All participants will be enrolled members in a federally recognized tribe, over 18 years of age and have a diagnosis of an anxiety, depression or substance use disorder.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of anxiety, depression or substance use disorder. Resident on or near Turtle Mountain or Spirit Lake reservation. Enrolled in federally recognized tribe.

Exclusion criteria

  • Literacy below fourth-grade level. Diagnosis of personality disorder or schizophrenia, or other impaired perception of reality.

Treatment and study plan

DSPT - Digital Support for Problem-solving Therapy

Combination Product

Mobile app breaking major treatment and social needs into subtasks, providing information, prompts and in-app payment to complete those tasks.

Primary outcomes

  1. Generalized Anxiety Disorder Scale-7

    Time frame: Six months

    Measure of Anxiety Symptoms

  2. Center for Epidemiological Studies Depression Scale

    Time frame: Six months

    Measure of Depression Symptoms

  3. Drug Abuse Screening Test

    Time frame: Six months

    Screening instrument for abuse of drugs other than alcohol

  4. Michigan Alcohol Screening Test

    Time frame: Six months

    Screening instrument for abuse of alcohol

Study contacts

Contact information is provided by the study sponsor or research team.

AnnMaria Demars, Ph.D.

CONTACT

[email protected]

3107179089

Maria Burns Ortiz, BA

CONTACT

[email protected]

2604021172

Sponsors and collaborators

Lead sponsor

7 Generation Games

Industry

Registry information

Acronym: Efficacy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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