CClinicalTrials.gg
Not yet recruitingNCT06346431EfficacyUpdated Apr 4, 2024

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

An Early Phase 1 interventional study of DSPT - Digital Support for Problem-solving Therapy in Anxiety, Depressive Symptoms and Substance Use Disorders, sponsored by 7 Generation Games. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by 7 Generation Games · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety
  • Depressive Symptoms
  • Substance Use Disorders
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 100 is close to the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

This is the only study on the registry with 7 Generation Games as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Literacy below fourth-grade level. Diagnosis of personality disorder or schizophrenia, or other impaired perception of reality.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    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.

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

  • No intervention
    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.

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.

06

What researchers measure

Primary outcomes

  1. Generalized Anxiety Disorder Scale-7

    Measure of Anxiety Symptoms

    Time frame: Six months

  2. Center for Epidemiological Studies Depression Scale

    Measure of Depression Symptoms

    Time frame: Six months

  3. Drug Abuse Screening Test

    Screening instrument for abuse of drugs other than alcohol

    Time frame: Six months

  4. Michigan Alcohol Screening Test

    Screening instrument for abuse of alcohol

    Time frame: Six months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

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

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06346431
Lead sponsor
7 Generation Games
Responsible party
Sponsor
First posted
Apr 4, 2024
Start date
Mar 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 4, 2024

Study contacts

AnnMaria Demars, Ph.D.
Contact
annmaria@7generationgames.com
3107179089
Maria Burns Ortiz, BA
Contact
maria@7generationgames.com
2604021172
AnnMaria Demars, Ph.D.
principal investigator · 7 Generation Games

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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