Chapter 25 · Canonical English edition

25. An Honest Look at the Limits of the Current Evidence Base

Functional Systems Facilitation · Dmitry Shamenkov

Section 33 of 53version 1.1 · July 2026Source: Book_OD
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25. An Honest Look at the Limits of the Current Evidence Base

I deliberately close Part V not with a list of achievements but with an honest look at the limitations. This is not false modesty; it is a matter of scientific integrity, and of recognizing that a serious program develops by honestly acknowledging what is not yet there.

The Main Limitations

Sample sizes in the direct studies are small. The largest direct study is n = 55 (2014); the current pre-post study on the platform is n = 54. This is enough to detect significant effects (which has been done), but not enough for rigorous statistical generalization to the population level. Reaching full scale — thousands and tens of thousands of participants in studies — is a task for the coming years.

Most of our studies are pre-post without a control group. We can see that change occurs, but we cannot rigorously separate the effect of the program itself from the effects of time, expectation, regression to the mean, and placebo. That is exactly why the planned RCT with a waitlist control is such an important next step.

Long-term follow-up data are limited. We see effects during and immediately after the Intensive. The effects at 3 months, at one year, and at 3 years need to be studied separately, and the corresponding studies are planned.

Most of the qualitative data come from a Russian-speaking audience. Although the program operates in 67 countries across 8 languages, the main body of documented self-reflection is in Russian. This calls for cross-cultural validation in other settings.

The AI diagnostic is a new tool that requires validation. Although we observe strong emotional and behavioral responses in 55% of those who complete it, formal validation of the instrument (test–retest reliability, convergent and divergent validity, predictive validity against objective outcomes) remains a task for the coming years.

Not all of the method’s mechanisms are described with equal rigor. Some components (the lifestyle foundation, the regularity of practice, the group format) rest on a large meta-analytic base. Others (the recurring, self-similar structure of the Intensive, work with the ancestral theme, the “sandwich effect” when diagnostics are combined with live work) we have described empirically, but they require separate formal studies of the underlying mechanism.

What We Are Doing to Address These Limitations

  • The RCT within my PhD research in Lisbon — to obtain controlled-trial data;

  • Systematic accumulation and analysis of platform data — to increase sample sizes and enable long-term observation;

  • Collaboration with independent research groups in the United States, Europe, and Russia — for cross-cultural validation and to strengthen the scientific independence of the results;

  • Publications in international peer-reviewed journals — to obtain external expert review;

  • Development of validation protocols for the AI diagnostic — a separate line of research.

What This Means for the Participant

If you are a participant in the program, or thinking of becoming one, and you want to understand what these limitations mean for you personally, here is my direct answer.

The method has a sound conceptual foundation in contemporary neurobiology, the theory of functional systems, and the biology of collective intelligence (Parts I–IV).

The method has real, confirmed effects on the people who have gone through it (section 21).

These effects agree with what the meta-analyses on related mechanisms would predict (section 23).

The method works at a scale of 60,000+ people across 67 countries over more than 15 years (section 24) — which in itself speaks to its durability.

The method is not an alternative to medical care for acute conditions (psychosis, severe depression with a risk of suicide, active addiction). It is a complement and a supportive environment for the long-term, systemic work of improving quality of life.

A full, controlled evidence base is still taking shape — but that is normal for a method that is actively developing and embedded in an academic program. We are building toward it systematically.

A Metaphor

FSF today is a map of the terrain, drawn from the results of hundreds of expeditions, which we are turning into satellite imagery. The map is accurate and tested — we can make out the main ridges, rivers, roads, and dangerous spots. The satellite imagery (large RCTs, meta-analyses of our own method, long-term follow-up) is the next level of detail, and it is the level we are moving toward. But even now this map can be followed reliably — and thousands of people are following it.

Transition to Part VI

We have traveled the entire main line of the document: why FSF is needed (Part I), what it is (Part II), how its components are built (Part III), why they work together (Part IV), and what documented results it has (the present Part V).

If this picture is convincing, the next question arises naturally: how do I personally enter this practice, and what do I do within it? That is the subject of Part VI — a practical guide to how to begin, how to continue, what to rely on, and where to go next.

Notes and Sources for Part V

  1. Shamenkov D. A., Ulyanin A. Yu., Sudakov K. V. The result of the practical application of an innovative system for managing human health, developed on the basis of the theory of functional systems of Academician P. K. Anokhin // Rehabilitation and Prevention–2014: collected materials of a scientific conference. Moscow: Publishing House of the I. M. Sechenov First MSMU, 2014. Pp. 219–220 (my publication).

  2. Merkulieva T. A., Kozlov V. V., Shamenkov D. A. The dynamics of participants’ self-relation in a program for reducing burnout // Bulletin of Integrative Psychology. 2020. No. 21. Pp. 219–222. Merkulieva T. A. A study of quality of life before and after the “Open Dialogue Intensive” program // The Human Factor: Social Psychologist. 2020. No. 2(40). Pp. 222–227. Merkulieva T. A. The application of the “Open Dialogue” method for the prevention and correction of burnout states // Psychology of the 21st Century. Yaroslavl, 2020. Pp. 253–256. Also: Merkuliev M. Yu., Shamenkov D. A. The development of a technology for human-potential development on the basis of the theory of functional systems of Academician P. K. Anokhin // Social Psychologist. 2022. No. 1(43). Pp. 73–84 (my co-authored publication).

  3. Shamenkov, D. (2024). Development of the Digital Mental Health Intervention and Online Peer Support Platform. Presentation of my program, 14th Doctoral Program in Public Health, Lisbon, November 2024. Data from a sample of n = 54 intensive participants at Opendialogue.space; measurements via WHOQOL, GAD-7, PHQ-9, and stress scales.

  4. Archive of case discussions of the Open Dialogue School. 75+ recorded complete case discussions over the period 2024–2026. Used as training material for the preparation of facilitators and as a corpus for further scientific analysis.

  5. Gloster, A. T., Walder, N., Levin, M. E., Twohig, M. P., & Karekla, M. (2020). The empirical status of acceptance and commitment therapy: A review of meta-analyses. Journal of Contextual Behavioral Science, 18, 181–192.

  6. Akbari, M., Seydavi, M., Hosseini, Z. S., Krafft, J., & Levin, M. E. (2022). Experiential avoidance in depression, anxiety, obsessive-compulsive related, and posttraumatic stress disorders: A comprehensive meta-analysis. Journal of Contextual Behavioral Science, 24, 65–78. N = 135,347.

  7. Flückiger, C., Del Re, A. C., Wampold, B. E., & Horvath, A. O. (2018). The alliance in adult psychotherapy: A meta-analytic synthesis. Psychotherapy, 55(4), 316–340. N = 30,000+ across 295 studies.

  8. Klimecki, O. M., Leiberg, S., Lamm, C., & Singer, T. (2013). Functional neural plasticity and associated changes in positive affect after compassion training. Cerebral Cortex, 23(7), 1552–1561.

  9. Bhasin, M. K., Dusek, J. A., Chang, B.-H., et al. (2013, 2018). Relaxation response induces temporal transcriptome changes in energy metabolism, insulin secretion and inflammatory pathways. PLoS ONE.

  10. Holt-Lunstad, J., Smith, T. B., & Layton, J. B. (2010). Social Relationships and Mortality Risk: A Meta-analytic Review. PLoS Medicine, 7(7). N = 308,849.

  11. Aizer, A. A. et al. (2013). Marital Status and Survival in Patients With Cancer. Journal of Clinical Oncology, 31(31), 3869–3876. N = 1,280,898.

  12. Kim, E. S. et al. (2022). Sense of Purpose in Life and Subsequent Physical, Behavioral, and Psychosocial Health. JAMA Network Open. Confirmed: Shiba, K. et al. (2023), N = 13,159.

  13. Kaveladze, B. et al. (2026). Single-session interventions for depression: a large multi-arm study. Nature Human Behaviour.

  14. Shreesha, L. & Levin, M. (2024). Stress-sharing as cognitive glue for collective intelligences. Biochemical and Biophysical Research Communications.

  15. Tung, A. et al. (2024). Embryonic protection through collective Ca²⁺/ATP signalling. Nature Communications.

  16. Woolley, A. W., Chabris, C. F., Pentland, A., Hashmi, N., & Malone, T. W. (2010). Evidence for a Collective Intelligence Factor in the Performance of Human Groups. Science, 330(6004), 686–688.

  17. Data on the scale of the program is given according to my presentation to the Doctoral Program in Public Health (Lisbon, 2024) and the current operational metrics of the Opendialogue.space platform.

  18. The complete list of my publications — 54 published works, 2 monographs, 18 patents on inventions and software products in the field of medical and social technologies — is provided in the Appendix to this document.

  19. The author’s PhD research at Nova University Lisbon (14th Doctoral Program in Public Health, started 2024). Topic: digital mental-health interventions based on dialogical and mindfulness practices.

  20. Study registration: ClinicalTrials.gov, identifier NCT07276451. Design: an RCT with a 30-day intervention and a waitlist control; ITT analysis; ANCOVA adjusting for baseline measures and confounders; instruments — WHOQOL-BREF, GAD-7, PHQ-9, social-connectedness scales.