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

NCT06346431 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 20240301
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety; Depressive Symptoms; Substance Use Disorders

Outcome Measures

Primary Outcomes (4)

• Generalized Anxiety Disorder Scale-7

  Measure of Anxiety Symptoms

  Six months

• Center for Epidemiological Studies Depression Scale

  Measure of Depression Symptoms

  Six months

• Drug Abuse Screening Test

  Screening instrument for abuse of drugs other than alcohol

  Six months

• Michigan Alcohol Screening Test

  Screening instrument for abuse of alcohol

  Six months

Study Arms (2)

App Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

DSPT - Digital Support for Problem-solving Therapy COMBINATION_PRODUCT

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

App Intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of anxiety, depression or substance use disorder. Resident on or near Turtle Mountain or Spirit Lake reservation. Enrolled in federally recognized tribe.

You may not qualify if:

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

Sponsors & Collaborators

• 7 Generation Games: lead

Related Publications (3)

• 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.

  RESULT

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

  RESULT

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

  RESULT

MeSH Terms

Conditions

Anxiety Disorders; Depression; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Chemically-Induced Disorders

Study Officials

• AnnMaria Demars, Ph.D.

  7 Generation Games

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AnnMaria Demars, Ph.D.

CONTACT

3107179089; annmaria@7generationgames.com

Maria Burns Ortiz, BA

CONTACT

2604021172; maria@7generationgames.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share