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

Anxiety Clinical Trial

— Efficacy  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346431
• Other study ID #: 20240301
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 2026
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: 7 Generation Games
• Contact: AnnMaria Demars, Ph.D.
• Phone: 3107179089
• Email: annmaria[@]7generationgames.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Symptoms
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Combination Product:
• DSPT - 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
7 Generation Games

References & Publications (3)

De Mars, A. & Longie, E. S. (2018). The value of perseverance: Using Dakota culture to teach mathematics. Transmotion, 4 (1), 113-131.

De Mars, A. (2010). Internet usage by Native Americans with Disabilities living on American Indian reservations in the Great Plains. Rural Special Education Quarterly, 29 (2), 34-40.

Rousey, A. M. & Longie, E. S. (2001). The tribal college as family support system. American Behavioral Scientist,44 (9), 1492-1504.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generalized Anxiety Disorder Scale-7	Measure of Anxiety Symptoms	Six months
Primary	Center for Epidemiological Studies Depression Scale	Measure of Depression Symptoms	Six months
Primary	Drug Abuse Screening Test	Screening instrument for abuse of drugs other than alcohol	Six months
Primary	Michigan Alcohol Screening Test	Screening instrument for abuse of alcohol	Six months