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

Early Phase 1

Not yet recruiting

• Conditions: Anxiety; Substance Use Disorders; Depressive Symptoms
• Interventions: Combination Product: DSPT - Digital Support for Problem-solving Therapy

• Registration Number: NCT06346431
• Lead Sponsor: 7 Generation Games

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-04
• Study Start: 2026-03
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App Intervention group	DSPT - Digital Support for Problem-solving Therapy	A project coordinator will meet with the participant to assist in installing the app on device and provide instruction in use. Participants will be able to access support from the app continuously. When in proximity, during service hours to an organization meeting needs identified by the individual, the app will prompt to take action. Data will be collected on symptoms at baseline, three and six months post.

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder Scale-7	Six months	Measure of Anxiety Symptoms
Drug Abuse Screening Test	Six months	Screening instrument for abuse of drugs other than alcohol
Michigan Alcohol Screening Test	Six months	Screening instrument for abuse of alcohol
Center for Epidemiological Studies Depression Scale	Six months	Measure of Depression Symptoms