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

NCT07104396 | Recruiting

• 1 other identifier: 1R43DA060729-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Substance Use Disorders (SUDs)

Keywords

digital therapeutics; substance use disorders; development platform

Outcome Measures

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".

  To be completed immediately after usability feedback session

Secondary Outcomes (1)

• Visual Analog Scales

  To be completed immediately after usability feedback session

Interventions

Cogito digital therapeutics development platform OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Square2 Systems, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Square 2 Systems

Hanover, New Hampshire, 03755, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Square2 Systems

CONTACT

(802) 526-4608

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: July 2, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

US (1)