24. The Scale of the Program and Its Scientific Infrastructure

24. The Scale of the Program and Its Scientific Infrastructure

Beyond the effectiveness data, one further factor matters: the scale at which the program operates and the scientific infrastructure within which it is developing.

Scale

At the time of writing, the FSF program has the following quantitative characteristics¹⁷:

For comparison, most psychotherapeutic methods, in the first 15–20 years of their existence, reach a scale of hundreds or a few thousand people. A reach of 60,000+ participants across 67 countries indicates broad uptake and operational maturity — though scale alone speaks to durability and adoption, not to effectiveness, which is the work of the preceding sections.

Scientific Infrastructure

In addition to my own publications (54 published works, 2 monographs, 18 patents on inventions related to information and social technologies in medicine)¹⁸, the program is now developing within an academic infrastructure.

The Lisbon doctoral study. I am pursuing a PhD at Nova University Lisbon (14th Doctoral Program in Public Health), devoted to digital mental-health interventions based on dialogical and mindfulness practices. The study encompasses the development of a digital intervention, the RCT protocol, and the statistical analysis¹⁹.

The scientific team working on the method today includes:

• Alexander Lebedev, MD PhD (Barcelona) — psychiatrist and data scientist with 16+ years of experience in biomedical research, including population studies and clinical trials in mental health. Director of Science.

• Mikhail Sinelnikov, MD PhD (New York) — editor-in-chief at BioMedCentral and a researcher in translational science, reparative regeneration, and clinical-trial management. An expert in biomedical research and research transparency.

• Elena Poghosyan, MD (Moscow) — plastic surgeon, medical translator, and researcher at the Center for Information and Social Technologies in Medicine at Sechenov University.

• Fyodor Buzinov — Lead Developer, responsible for the technological development of the platform.

This is not “one author and his method” but an international team of specialists in biomedical research, psychiatry, clinical studies, methodology, and technology.

The Planned RCT

As part of my PhD research at Nova University Lisbon, a randomized controlled trial (RCT) of the Opendialogue.space platform is planned²⁰. The protocol:

• Design: a randomized controlled trial with a 30-day intervention and a waitlist control;

• Groups: Intervention (access to the platform) vs. Control (waitlist);

• Inclusion criteria: aged 18 or older; no current clinical diagnosis of a mental health disorder; no mental-health treatment or psychotropic medication started in the past 3 months; able to access the internet and give informed consent;

• Exclusion criteria: current engagement with a mental-health professional or therapy; inability to access the platform or to consent; PHQ-9 ≥ 15 or GAD-7 ≥ 15 at baseline (referred to specialist services and excluded);

• Analysis: Intention-to-treat (ITT); ANCOVA adjusting for baseline measures and potential confounders (age, sex); handling of missing data through multiple imputation;

• Outcomes: primary — change in WHOQOL-BREF total score (day 0 to day 31; ≥ 10% improvement pre-specified); secondary — SWLS, PSS, GAD-7, PHQ-9, the Communitas Scale (social connectedness), and the MLQ; mediators — platform adherence and concomitant medication use; planned enrollment 82 (41 + 41);

• Registration & status: registered on ClinicalTrials.gov as NCT07276451 (Org Study ID 21/2025; sponsor Universidade Nova de Lisboa; responsible party: PI Dmitry Shamenkov). Status: NOT_YET_RECRUITING — registered, recruitment not yet begun, no results.

The trial is registered but not yet recruiting (estimated start January 2026, completion September 2026), and no results exist yet; once completed it will provide the first controlled, RCT-level test of the method.

Partnerships and Infrastructure

The program is also developing in partnership with:

• Sechenov University (I. M. Sechenov First Moscow State Medical University) — the Research and Educational Center “Information and Social Technologies in Medicine,” which I headed and which continues its work in this direction;

• Nova University Lisbon — the Doctoral Program in Public Health.