APPENDIX D. Protocol of the Planned RCT (NCT07276451)

This appendix reproduces the official protocol of the planned randomized controlled trial evaluating the Opendialogue.space platform, as registered on ClinicalTrials.gov.

The study is being conducted as part of my doctoral program at Nova University Lisbon (14th Doctoral Program in Public Health). Its findings are intended to be the next step in building the method’s evidence base.

D.1. Study Identification

D.2. Brief Summary

“RCT to evaluate the efficacy of a digital mental health intervention platform with open peer support in improving participant quality of life.”

D.3. Conditions

• Anxiety;

• Depression and Quality of Life;

• Quality of Life — general.

D.4. Intervention

Type: OTHER (behavioral / digital).

Name: Participation in digital mental health intervention and open peer support platform.

Description: participation in the program on the Opendialogue.space digital platform, comprising:

• Daily mindfulness exercises;

• Open dialogue group sessions (the method now called Functional Systems Facilitation; registered under its former name);

• A peer-support forum;

• Mentor chat;

• A resource library of pre-recorded videos and guides.

(Total intervention duration: 30 days.)

D.5. Study Design

D.6. Primary Outcome

Change in overall quality of life as measured by the WHOQOL-BREF from baseline (day 0) to post-intervention assessment (day 31).

Instrument: WHOQOL-BREF (the World Health Organization’s abbreviated 26-item quality-of-life questionnaire, covering four domains: physical, psychological, social relationships, and environment).

Variable type: continuous.

Pre-specified threshold for clinically meaningful improvement: a ≥10% increase in total score from baseline, used here as a working definition (not a formally validated WHOQOL-BREF minimal clinically important difference).

Timeframe: 1 month.

D.7. Secondary Outcomes

All measured over a 1-month timeframe (from day 0 to day 31):

D.8. Other Outcome Measures

Effect mediators:

• Adherence to platform — measured by the frequency of platform interactions;

• Concomitant medication use — concurrent use of medications.

These measures let us estimate what proportion of the effect is mediated by the degree of platform engagement, and whether the effects are independent of any potential pharmacological influence.

D.9. Participant Criteria

Sex and Age

• Sex: ALL;

• Age: ADULT, OLDER_ADULT (adults and older adults — 18 years and over).

Inclusion Criteria

• Aged 18 years or older;

• No current clinical diagnosis of a mental health disorder;

• No mental-health treatment or psychotropic medication initiated within the past 3 months;

• Able to access the internet and provide informed consent.

Exclusion Criteria

• Current engagement with a mental-health professional or therapy;

• Inability to access the platform or to provide informed consent;

• PHQ-9 score ≥15 or GAD-7 score ≥15 at baseline — these participants are referred to specialist services and excluded from further participation.

These criteria correspond to the limits of the method’s applicability described in Part VII of this document.

Sample size. For a dichotomous endpoint (improvement vs. no improvement), an anticipated improvement incidence of 45% in the intervention group versus 75% in the control group, 95% confidence, a 5% margin of error, 80% power, and a 1:1 enrolment ratio, a total of 82 participants (41 intervention, 41 control) was chosen.

D.10. Statistical Analysis

Primary approach: Intention-to-Treat (ITT) — analysis of all randomized participants according to their originally assigned treatment, regardless of actual adherence.

Primary analysis method: ANCOVA (analysis of covariance), controlling for:

• Baseline values of the primary outcome measure;

• Potential confounders: age, sex, and other clinically relevant variables.

Handling of missing data: Multiple Imputation — the standard approach for RCTs, which allows rigorous handling of the missing data that inevitably arise in longitudinal studies.

D.11. Timeline

D.12. Research Team Structure

Sponsor: Universidade Nova de Lisboa (Nova University of Lisbon).

Principal Investigator: Dmitry Shamenkov, MD, within the 14th Doctoral Program in Public Health.

Research team (described in Part V, Section 24):

• Alexander Lebedev, MD PhD (Barcelona) — Director of Science, psychiatrist, data scientist;

• Mikhail Sinelnikov, MD PhD (New York) — Editor-in-Chief of BioMedCentral, biomedical research expert;

• Elena Pogosyan, MD (Moscow) — researcher at the Center for Information and Social Technologies in Medicine, Sechenov University;

• Fyodor Buzinov — Lead Developer of the platform.

D.13. Ethical Considerations

The study is reviewed by the Ethics Committee of Nova University Lisbon. All participants sign informed consent. Data confidentiality is ensured in accordance with GDPR and Portuguese national law.

All participants in the control (waitlist) group are guaranteed access to the platform once the control measurement period concludes — an ethically sound, standard practice for waitlist control designs.

Should a participant experience clinically significant deterioration (suicidal ideation, acute symptomatology), emergency referral protocols are in place.

D.14. Expected Contribution to the Method’s Scientific Base

It is worth noting at the outset that the principal investigator is also the method’s author; the trial is therefore not an independent evaluation, and its results should be read with that in mind. If completed, and depending on its results, this RCT could provide:

1. The first registered RCT of this digital FSF platform — distinct from the Finnish Open Dialogue approach in psychiatry — raising the evidence base from uncontrolled pre-post data toward a controlled, RCT-level test;

2. A controlled test of the effects suggested by the pre-post data on the platform (Section 21 of the main document), to confirm or disconfirm them under randomization;

3. Data on effect mediators — what proportion of the outcomes is attributable to platform use rather than to other factors;

4. Publication in an international peer-reviewed journal — for external expert evaluation and broader academic visibility of the method;

5. A foundation for further research — comparative effectiveness studies, long-term follow-up, and meta-analyses.

D.15. How to Follow the Study’s Progress

Official study page: clinicaltrials.gov/study/NCT07276451

Study updates: will be published on the Opendialogue.space platform and in my academic publications as the study progresses.

Results publication: upon completion of the RCT, the findings will be published in an international peer-reviewed journal, with a preprint posted in advance on medRxiv. The publication will be announced through all of the program’s channels.

This protocol is current as of December 11, 2025 (the date of first registration on ClinicalTrials.gov). All protocol updates will be reflected on the study’s official page.

END OF DOCUMENT

© Dmitry Shamenkov. The Functional Systems Facilitation Method. Lisbon, April 2026.

Contact: shamenkov@opendialogue.space · opendialogue.space