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

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

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06346431
Acronym
Efficacy
Enrollment
100
Registered
2024-04-04
Start date
2026-03-31
Completion date
2026-12-31
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depressive Symptoms, Substance Use Disorders

Brief summary

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.

Detailed description

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.

Interventions

COMBINATION_PRODUCTDSPT - Digital Support for Problem-solving Therapy

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

Sponsors

7 Generation Games
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Generalized Anxiety Disorder Scale-7Six monthsMeasure of Anxiety Symptoms
Center for Epidemiological Studies Depression ScaleSix monthsMeasure of Depression Symptoms
Drug Abuse Screening TestSix monthsScreening instrument for abuse of drugs other than alcohol
Michigan Alcohol Screening TestSix monthsScreening instrument for abuse of alcohol

Contacts

Primary ContactAnnMaria Demars, Ph.D.
annmaria@7generationgames.com3107179089
Backup ContactMaria Burns Ortiz, BA
maria@7generationgames.com2604021172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026