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Add plain-language depression trial summary (#464)#477

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Add plain-language depression trial summary (#464)#477
yehudalevy-collab wants to merge 2 commits into
OpenwaterHealth:mainfrom
yehudalevy-collab:codex/depression-trial-summary

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Summary

Closes #464.

Adds an 823-word plain-language summary of the University of Arizona Open-LIFU depression trial for prospective participants, IRB members, and other non-specialist readers.

  • Explains what the study tested, what researchers measured, and what they observed
  • Reports the cohort, schedule, symptom trajectory, response, and remission numbers from the primary paper
  • Separates observed improvement from causal or clinical claims
  • States the small, open-label, uncontrolled design and short follow-up prominently
  • Preserves the required regulatory disclaimer verbatim
  • Links the peer-reviewed paper and ClinicalTrials.gov record

The issue refers to a wiki "Clinical Resources" section. The public wiki does not currently expose that structure, while the maintainer guidance and repository-based delivery used for #459 / #475 place the Markdown in this repository. I followed that live precedent with a root-level file and am happy to relocate it if maintainers prefer another path.

Clinical-framing notes

The paper is internally inconsistent about why two participants withdrew: the abstract says time constraints, while the Results and Discussion say lack of symptom improvement. The summary reports both accounts and retains the point on which the paper is consistent: withdrawal was not attributed to an adverse event.

The paper does not print exact group-average BDI-II values for weeks 1 and 3. The summary therefore reports the exact baseline mean and modeled change, describes the visible trajectory in Figure 3, and does not estimate follow-up means from the chart.

Clinician review remains required before merge, as specified in #464. After the English clinical wording is approved, I would also be glad to prepare a Spanish version if that would be useful.

Test plan

  • Cross-check every numerical statement against Schachtner et al. (2025)
Summary statement Primary-paper location Source value
Cohort and age range Abstract, Methods: Participants 20 enrolled; ages 18–50
Existing medication Abstract; Table 1 50% reported current psychiatric medication use
Device and session schedule Methods: Overview; Ultrasound session procedures 128-element array; 10 minutes per session; 5 sessions in week 1, then 3 per week for 2 weeks if needed; up to 11 sessions
Baseline BDI-II and trajectory Table 1; Statistical analysis; Results; Figure 3 Mean 38.85 at baseline; modeled decrease 10.9 points per assessment-time step; largest visible decrease by week 1, followed by a smaller decrease through week 3
BDI-II response Results: Depression symptoms and RNT 60% (12/20) met response criteria
HDRS response Results: Depression symptoms and RNT 45% (9/20) met response criteria
Remission Methods: Remission criteria; Results 35% (7/20) met BDI-II <13 and HDRS <8 thresholds
Study duration and withdrawals Abstract; Results: Adverse events Up to 3 weeks; 2/20 withdrew after week 1; no withdrawal attributed to an adverse event
  • Confirm the regulatory disclaimer matches Plain-language summary of the depression trial outcomes (good first issue) #464 verbatim
  • Confirm all abbreviations and specialist terms are defined on first use
  • Confirm the 823-word document fits a five-minute read at approximately 165 words per minute
  • Verify the DOI and ClinicalTrials.gov links resolve successfully
  • Run pre-commit on depression_trial_summary.md (all applicable hooks pass, including Prettier and codespell)
  • Obtain clinician review before merge

yehudalevy-collab and others added 2 commits July 10, 2026 16:29
Address review feedback on OpenwaterHealth#464:
- The half-of-cohort medication note said 'for anxiety or depression', but
  Table 1 lists non-antidepressant medications too; the paper's own wording
  is neutral ('current psychiatric medication use').
- Add the C-SSRS suicidality-monitoring outcome (no imminent-risk ideation;
  one transient post-week-3 increase the authors attributed to an unrelated
  personal event), which the safety paragraph had omitted.

Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
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Plain-language summary of the depression trial outcomes (good first issue)

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