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

7 Generation Games

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Depressive Symptoms; Substance Use Disorders; Anxiety

Treatments: Combination Product: DSPT - Digital Support for Problem-solving Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06346431

20240301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

App Intervention group

Experimental group

Description:

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.

Treatment:

Combination Product: DSPT - Digital Support for Problem-solving Therapy

Control group

No Intervention group

Description:

Data will be collected on symptoms at baseline, three and six months post. As individuals have a diagnosis of mental illness they may be receiving "Treatment as usual" for their reservation/ service provider, but no additional services will be provided by the sponsor.