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

NCT ID: NCT06346431

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Anxiety Depressive Symptoms Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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App Intervention group

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.

Group Type EXPERIMENTAL

DSPT - Digital Support for Problem-solving Therapy

Intervention Type COMBINATION_PRODUCT

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

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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7 Generation Games

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AnnMaria Demars, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

7 Generation Games

Central Contacts

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AnnMaria Demars, Ph.D.

Role: CONTACT

3107179089

Maria Burns Ortiz, BA

Role: CONTACT

2604021172

References

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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.

Reference Type RESULT

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

Reference Type RESULT

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

Reference Type RESULT

Other Identifiers

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20240301

Identifier Type: -

Identifier Source: org_study_id

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