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Clinical Evidence

The science behind Somana

Somana is built on established, peer-reviewed clinical methodologies. We do not invent new psychology - we structure the delivery of proven techniques into an accessible, measurable digital wellness platform.

1. Validated Methodologies

Every core component of Somana is grounded in published clinical evidence.

PHQ-9 - Patient Health Questionnaire

Depression screening

A 9-item validated instrument for measuring depression severity. Widely adopted in primary care, psychiatric settings, and clinical research globally.

Kroenke, K., Spitzer, R.L., & Williams, J.B. (2001). The PHQ-9: Validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606-613.

GAD-7 - Generalised Anxiety Disorder

Anxiety screening

A 7-item validated instrument for measuring anxiety severity. Recommended by NICE guidelines and used extensively in both clinical and research settings.

Spitzer, R.L., Kroenke, K., Williams, J.B., & Lowe, B. (2006). A brief measure for assessing generalised anxiety disorder: the GAD-7. Archives of Internal Medicine, 166(10), 1092-1097.

WHO-5 - World Health Organization Wellbeing Index

General wellbeing

A 5-item positive wellbeing index developed by the WHO. Validated across diverse populations and widely used as a screening tool for depression and as an outcome measure in clinical trials.

World Health Organization (1998). WHO-Five Well-being Index. WHO Regional Office for Europe, Copenhagen.

Expressive Writing / Journaling

Therapeutic journaling

Structured expressive writing has demonstrated measurable benefits for psychological wellbeing, stress reduction, and emotional processing in controlled studies.

Pennebaker, J.W. (1997). Writing about emotional experiences as a therapeutic process. Psychological Science, 8(3), 162-166.

Controlled Breathing / Breathwork

Stress and anxiety reduction

Diaphragmatic and paced breathing techniques have established efficacy for reducing physiological stress responses, improving heart rate variability, and lowering cortisol levels.

Ma, X., et al. (2017). The effect of diaphragmatic breathing on attention, negative affect, and stress in healthy adults. Frontiers in Psychology, 8, 874.

Behavioural Activation

CBT core component

A structured approach within CBT that encourages engagement in valued activities to counteract withdrawal and avoidance patterns common in depression.

Jacobson, N.S., et al. (2001). Behavioral activation treatment for depression: Returning to contextual roots. Clinical Psychology: Science and Practice, 8(3), 255-270.

Mindfulness Meditation

Evidence-based practice

Systematic reviews and meta-analyses support the use of meditation programmes for reducing anxiety, depression, and pain, with moderate evidence of improved stress and mental health quality of life.

Goyal, M., et al. (2014). Meditation programs for psychological stress and well-being: A systematic review and meta-analysis. JAMA Internal Medicine, 174(3), 357-368.

2. Measurable Outcomes

Somana does not claim to cure or treat mental health conditions. Instead, we focus on a measurable and defensible claim: "Somana improves engagement, adherence, and consistency between therapeutic sessions."

This is measurable through the following data points collected within the platform:

  • Engagement Frequency - Sessions per week, daily active usage, feature utilisation across meditation, journaling, breathwork, and mood tracking.
  • Adherence Rate - Tasks assigned by healthcare providers versus tasks completed.
  • Consistency Streaks - Consecutive days of engagement, gap frequency analysis, and streak recovery patterns over time.
  • Session Completion - Percentage of started sessions that are completed.
  • Between-Session Engagement - Activity levels between scheduled therapy appointments.

3. Outcome Correlation

By correlating engagement metrics with longitudinal clinical assessment scores (PHQ-9, GAD-7, WHO-5), Somana can surface patterns such as:

  • Users with higher weekly session counts showing greater symptom score improvement over 30-day periods
  • Correlation between streak consistency and wellbeing score stability
  • Engagement drops preceding score deterioration, providing early intervention signals
  • Session completion rates as predictors of assessment score trajectory

4. Research Readiness

Somana provides a ready-made digital infrastructure for clinical research partnerships:

  • Structured Data Collection - Automated, timestamped recording of engagement events, mood changes, session metrics, and clinical assessment completions.
  • Validated Assessment Instruments - PHQ-9, GAD-7, and WHO-5 with automated baseline scheduling, monthly follow-up, and provider-requested ad-hoc assessments.
  • Longitudinal Outcome Tracking - Correlation analytics linking engagement patterns to symptom score trajectories over time.
  • Privacy-First Architecture - GDPR Article 9 compliance. Journal content remains exclusively on-device. Only anonymised metadata is available for research analysis.
  • Cohort Analytics - Aggregate, anonymised outcome data across user populations.
  • Healthcare Professional Integration - Secure provider dashboard with clinical notes, medication tracking, therapy session records, and patient-provider linking.

5. National & International Research Alignment

Somana operates within an active, government-backed digital mental health ecosystem.

Sources: Presentations and proceedings from the 3rd National Digital Mental Health Conference, "Realising the Vision of Digital Mental Health," Limerick, Ireland, 20 February 2026.

Ireland's Digital Mental Health Strategy 2026-2030

Ireland's "Sharing the Vision" mental health policy explicitly calls for digital tools to enhance service delivery. Recommendation 2 states that "evidence-based digital and social media channels should be used to the maximum to promote mental health." Recommendation 31 calls for "digital health solutions to enhance service delivery and empower service users." Somana's approach aligns directly with both.

Department of Health / HSE (2026). National Digital Mental Health Strategy 2026-2030. Launched at the 3rd National Digital Mental Health Conference, Limerick, 20 February 2026.

Jigsaw PROACT Study

Jigsaw, Ireland's primary youth mental health service, uses PHQ-9 and GAD-7 for routine outcome measurement across its national network - the same validated instruments integrated into Somana. Their PROACT study applies advanced data analytics to predict mental health outcomes and personalise supports, an approach directly parallel to Somana's outcome correlation analytics.

Moore, J., Duffy, J., & Lyng, J. (2026). Building a Digital Learning System in Youth Mental Health. 3rd National Digital Mental Health Conference, Limerick.

MOST Digital Intervention Study

A pilot randomised controlled trial (N=74) of a digital mental health intervention for university students with pre-existing mental health difficulties. Used PHQ-9 and GAD-7 as outcome measures. Results showed reduced symptom severity (GAD-7: d = -0.5, PHQ-9: d = -0.34) with 74% of participants engaging beyond 12 weeks.

Donohoe, G. & Dwan-O'Reilly, M. (2026). Advances in Digital Interventions in Youth Mental Health. University of Galway.

MHRA Digital Mental Health Technologies Framework

The UK's MHRA, funded by the Wellcome Trust, is developing classification guidance and clinical evaluation standards for Digital Mental Health Technologies (DMHTs). Somana's privacy-first architecture, use of validated instruments, and clear positioning as a wellness engagement platform align with emerging regulatory best practice for non-medical-device digital health tools.

YouthDMH COST Action (CA23153)

A pan-European research network spanning 34 countries with 549 working group members, dedicated to digital youth mental health. Working groups cover help-seeking behaviour, contextual assessment, intervention design, and policy impact - all areas directly relevant to Somana's clinical model.

Irish Market Context

  • 1 in 5 Irish adults report a probable mental health disorder
  • 59% of Irish university students experience depressive symptoms; 28.5% report suicidal ideation
  • 79% of digital mental health users access platforms via mobile - validating mobile-first design
  • Neurodivergent young people are 2.5x more likely to seek digital mental health support
  • spunout Navigator reached 36,809 users in 8 months, demonstrating strong demand for digital mental health tools in Ireland

Summary

  • Ingredient Validation: Every core methodology is clinically validated with published peer-reviewed evidence.
  • Efficacy Validation: Engagement, adherence, and consistency are continuously measured and quantifiable.
  • Mechanism Validation: Correlation between structured engagement and symptom score improvement is observable and publishable.
  • Ecosystem Validation: Somana's instruments, methodology, and approach are aligned with active national policy, government-funded research programmes, and pan-European clinical networks.

For research partnership enquiries: info@somanaapp.com

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