CClinicalTrials.gg
RecruitingNCT07104396Updated Aug 11, 2025

Cogito: A Turnkey Solution for Rapidly Developing, Evaluating, Deploying, and Scaling Digital Therapeutics

An observational study in Substance Use Disorders (SUDs), sponsored by Square2 Systems, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Square2 Systems, Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

This is a research study to evaluate the usability of the Cogito digital therapeutics development platform.

The Cogito platform is designed to allow researchers who are seeking to embed an evidence-based behavioral therapy into a digital delivery platform to do so via a drag and drop interface with no programming skills necessary. It will provide the components for building a digital therapeutic for any health condition and population.

And in this initial study, the research team plans to examine the usability of Cogito in building a digital therapeutic for substance use disorders (SUDs).

Read the detailed description

Each participant will be asked to:

  • Complete an interactive tutorial describing what Cogito is and how to create a sample guide, sample activities, and a sample survey.
  • Explore using the various Cogito processes by completing a "functionality scavenger hunt". In this scavenger hunt, participants will be walked through a series of activities to create new guides, activities and surveys.
  • Complete surveys to provide feedback on participants' experience using Cogito
02

Conditions studied

  • Substance Use Disorders (SUDs)

Keywords

  • digital therapeutics
  • substance use disorders
  • development platform
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 20 is below the median of 250 across 296 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Square2 Systems, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The research team will recruit 20 (> 18 years) clinical researchers/clinicians to utilize Cogito to provide feedback on its usability, utility, and likability and relevance as a development and hosting platform. Participants must be PhD and/or MD-level scientists at academic institutions or digital health companies at the level of Post-doctoral Fellow or higher. Participants must be trained/training in SUD research. Participants must state a specific interest in digital therapeutics for SUDs. The researchers expect participants will have interests ranging from developing novel behavioral digital therapies for SUDs to digital therapeutics that promote adherence to SUD medications to digital therapeutics for SUDs and co-occurring conditions to digital management tools which help individuals with care transitions.

Inclusion criteria

  • At least 18 years
  • PhD and/or MD-level (or equivalent) scientists at academic institutions or digital health companies at the level of Post-doctoral Fellow or higher.
  • Training or trained in substance use disorder (SUDs) research.
  • Must state a specific interest in digital therapeutics for SUDs.

Exclusion criteria

Exclusion Criteria:

  • Those who do not meet inclusion criteria.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • OtherCogito digital therapeutics development platform

    Cogito will provide a turnkey solution for rapidly developing, evaluating, deploying, and scaling digital therapeutics for the prevention, treatment and/or management of any disease or disorder. This platform will allow researchers who are seeking to embed an evidence-based behavioral therapy into a digital delivery platform to do so via a drag and drop interface with no programming skills necessary. It will provide all the components for building a digital therapeutic for any health condition and population. Overall, Cogito offers great promise to markedly accelerate the pace and impact of science based digital therapeutics.

06

What researchers measure

Primary outcomes

  1. System Usability Scale

    Each participant will be asked to complete the standardized 10-item System Usability Scale (SUS) to evaluate the usability of Cogito (e.g., "I think I would like to use this system frequently"), ranging from "strongly agree" to "strongly disagree".

    Time frame: To be completed immediately after usability feedback session

Secondary outcomes

  1. Visual Analog Scales

    100 mm Visual Analog measures, ranging from "Not at All" anchored at 0 to "Very" anchored at 100 for each question, with every question worded positively to assess how (1) easy to use, (2) understandable, (3) likable, (4) useful (5) relevant they found the Cogito development functionality in each stage of the scavenger hunt as well as (6) how likely they would be to use Cogito as a digital therapeutics development and hosting platform.

    Time frame: To be completed immediately after usability feedback session

07

Study locations

1 of 1 sites recruiting
  • Square 2 Systems
    Hanover, New Hampshire 03755, United States
    • Research Coordinator · Contact · (802) 526-4608
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07104396
Lead sponsor
Square2 Systems, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Grabinski (Principal Investigator, Square2 Systems, Inc.) — Principal investigator
First posted
Aug 5, 2025
Start date
Jul 2, 2025
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Aug 11, 2025

Study contacts

Square2 Systems
Contact
(802) 526-4608

Oversight

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

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