Clinical trial NCT06346431: Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms
Official title: Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Anxiety
Depressive Symptoms
Substance Use Disorders
Lead sponsor: 7 Generation Games
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Generalized Anxiety Disorder Scale-7
timeFrame: Six months
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Six months
measure: Drug Abuse Screening Test
timeFrame: Six months
measure: Michigan Alcohol Screening Test
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 7 Generation Games
name: AnnMaria Demars, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rousey, A. M. & Longie, E. S. (2001). The tribal college as family support system. American Behavioral Scientist,44 (9), 1492-1504.
citation: De Mars, A. & Longie, E. S. (2018). The value of perseverance: Using Dakota culture to teach mathematics. Transmotion, 4 (1), 113-131.